psychological therapies including dialectical behaviour therapy for borderline personality disorder

Health Technology Assessm

ent 2006;Vol. 10: No. 35

Psychological therapies for borderline personality disorder

Psychological therapies includingdialectical behaviour therapy forborderline personality disorder: a systematic review and preliminaryeconomic evaluation

J Brazier, I Tumur, M Holmes, M Ferriter, G Parry, K Dent-Brown and S Paisley

Health Technology Assessment 2006; Vol. 10: No. 35

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Psychological therapies includingdialectical behaviour therapy forborderline personality disorder: a systematic review and preliminaryeconomic evaluation

J Brazier,1* I Tumur,1 M Holmes,1 M Ferriter,2

G Parry,1 K Dent-Brown1 and S Paisley1

1 School of Health and Related Research (ScHARR), University of Sheffield,UK

2 Department of Research and Development, Nottinghamshire HealthcareNHS Trust, Retford, UK

* Corresponding author

Declared competing interests of authors: none

Published September 2006

This report should be referenced as follows:

Brazier J, Tumur I, Holmes M, Ferriter M, Parry G, Dent-Brown K, et al. Psychologicaltherapies including dialectical behaviour therapy for borderline personality disorder: a systematic review and preliminary economic evaluation. Health Technol Assess2006;10(35).

Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE,Excerpta Medica/EMBASE and Science Citation Index Expanded (SciSearch®) and Current Contents®/Clinical Medicine.

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Objectives: To summarise the available evidence onthe clinical effectiveness and cost-effectiveness ofpsychological therapies including dialectical behaviourtherapy (DBT) for borderline personality disorder(BPD).Data sources: Electronic databases were searched upto March 2005.Review methods: Relevant studies were assessedusing standard checklists and data were abstracted bytwo reviewers using standardised forms. Separateeconomic evaluations were undertaken for six selectedrandomised controlled trials (RCTs). Cost-effectivenesswas assessed in terms of cost per parasuicide eventavoided in all six trials and cost per quality-adjusted life-year (QALY) in four of them. All results are at2003–4 prices and for 12 months follow-up.Results: Nine RCTs and one non-RCT of moderate topoor quality were identified in the clinical effectivenessreview. They provided some evidence that DBT ismore effective than treatment as usual (TAU) for thetreatment of chronically parasuicidal and drug-dependent borderline women; that DBT-orientatedtherapy is more effective than client-centred therapy(CCT) for the treatment of BPD; and that DBT is aseffective as comprehensive validation therapy plus 12-Step for the treatment of opioid-dependent borderlinewomen. There was also some evidence that partialhospitalisation is more effective than TAU in thetreatment of BPD, good evidence that manual-assistedcognitive behavioural therapy (MACT) is no moreeffective than TAU in the treatment of BPD and someevidence that interpersonal group therapy is no more

effective than individual mentalisation-based partialhospitalisation (MBT) for the treatment of BPD.However, these results should be interpreted withcaution as not all studies were primarily targeted toborderline symptoms and there were considerabledifferences between the studies. The assessment ofcost-effectiveness found a mix of results in the fourtrials of DBT, along with the high levels of uncertaintyand the limitations in the analyses. The findings do notsupport the cost-effectiveness of DBT though theysuggest it has the potential to be cost-effective. Theresults for MBT are promising, though againsurrounded by a high degree of uncertainty and forMACT, the analysis suggests that the intervention isunlikely to be cost-effective.Conclusions: The overall efficacy of psychologicaltherapies is promising; however, at this stage theevidence is inconclusive. The cost-effectiveness of theintervention in six RCTs examined, however, does notsupport the cost-effectiveness of DBT althoughpotential is suggested. There is a need for considerableresearch in this area. This research should involveappropriately powered head-to-head RCTs ofpsychological therapies; a survey of current practiceand the use of the full range of services by people withBPD to inform future economic analyses; full resource-use data collected in the context of pragmatic clinicaltrials; psychometric assessment of the validity of theEQ-5D or other generic and condition-specificpreference-based measures in BPD, and thedevelopment of a more formal cost-effectivenessmodel using the above data.


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© Queen’s Printer and Controller of HMSO 2006. All rights reserved.

Abstract

Psychological therapies including dialectical behaviour therapyfor borderline personality disorder: a systematic review andpreliminary economic evaluation

J Brazier,1* I Tumur,1 M Holmes,1 M Ferriter,2 G Parry,1 K Dent-Brown1 and S Paisley1

1 School of Health and Related Research (ScHARR), University of Sheffield, UK2 Department of Research and Development, Nottinghamshire Healthcare NHS Trust, Retford, UK* Corresponding author


v

Glossary and list of abbreviations ............. vii

Executive summary .................................... ix

1 Aim of the review ...................................... 1

2 Background ................................................ 3Description of underlying health problem ...................................................... 3Description of new intervention ................ 3Current evidence ........................................ 5

3 Effectiveness ............................................... 7Methods for reviewing effectiveness .......... 7Results ........................................................ 8

4 Cost-effectiveness ...................................... 23Systematic review of existing economicliterature ..................................................... 23Cost-effectiveness and cost–utility analysis ....................................................... 25Methods by study ....................................... 30Cost-effectiveness results ............................ 32Univariate sensitivity analysis .................... 47

5 Discussion ................................................... 49Main results: clinical effectiveness ............. 49Main results: cost-effectiveness .................. 49Assumptions, limitations and uncertainties ............................................... 50Need for further research .......................... 51

6 Conclusions ................................................ 53

Acknowledgements .................................... 55

References .................................................. 57

Appendix 1 Identification of studies ......... 63

Appendix 2 Database keyword strategies ... 65

Appendix 3 Evidence tables for BPD studies ......................................................... 73

Appendix 4 Excluded studies .................... 107

Appendix 5 Consensus trial quality ratingsaccording to Lackner’s quality checklist .... 109

Appendix 6 British Medical Journalchecklist for economic evaluations ............ 111

Appendix 7 Case studies ........................... 115

Appendix 8 Mapping BDI to EQ-5D ........ 117

Health Technology Assessment reportspublished to date ....................................... 119

Health Technology Assessment Programme ................................................ 133

Contents


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Glossary and list of abbreviations

GlossaryClient-centred therapy Model of supportivetherapy based on Carkuff ’s model whichemphasises empathic understanding of thepatient’s sense of aloneness and provides asupportive attitude on an individual basis.

Cognitive behaviour therapy The pragmaticcombination of concepts and techniques fromcognitive and behaviour therapies common inclinical practice.

Comprehensive validation therapy with 12-Step A manualised approach that providesthe major acceptance-based strategies such astherapeutic warmth, responsiveness andempathy in combination with the 12-Stepprogramme.

Dialectical behaviour therapy Combinationof standard cognitive behavioural techniqueswith acceptance-based strategies and strategiesdesigned to keep the therapy balanced betweenchange and acceptance (dialectical strategies).

Manual-assisted cognitive behaviour therapyA 70-page manual that consists of a brief formof cognitive behaviour therapy combined withdialectical behaviour therapy techniquespotentially suitable for widespread use inroutine healthcare settings.

Mentalisation-based partial hospitalisationIntegrates individual and group psychoanalyticpsychotherapy within a limit-setting,structured, flexible and reliable partialhospitalisation. The mentalisation-based partialhospitalisation reflects both the therapeuticand management difficulties, with an emphasison the relational aspects of the disorder.

Psychodynamic therapy Emphasisespersonality structure and development andaims to provide insight for people, allowingthem to understand their feelings and to findbetter coping mechanisms.

List of abbreviationsA&E accident and emergency

AUC area under the curve

BAI Beck Anxiety Inventory

BDI Beck Depression Inventory

BHS Beck Hopelessness Scale

BPD borderline personality disorder

BPDSI Borderline Personality DisorderSeverity Index

BPRS Brief Psychiatric Rating Scale

BSI Brief Symptom Inventory

CASP Critical Appraisal Skills Programme

CBT cognitive behavioural therapy

CCDAN Cochrane Collaboration Depressionand Anxiety Neurosis Review Group

CCT client-centred therapy

CEAC cost-effectiveness acceptability curve

continued

Technical terms and abbreviations are used throughout this report. The meaning is usually clear fromthe context, but a glossary is provided for the non-specialist reader. In some cases, usage differs in the

literature, but the term has a constant meaning throughout this review.

List of abbreviations continued

CI confidence interval

CRD Centre for Reviews andDissemination

CSRI Client Service Receipt Inventory

CVT+12S comprehensive validation therapywith 12-Step

DBT dialectical behaviour therapy

DES Dissociative Experiences Scale

df degree of freedom

DIB Diagnostic Interview forBorderlines

DSH deliberate self-harm

DSM Diagnostic and Statistical Manualof Mental Disorders

EQ-5D EuroQol 5 Dimensions

EuropASI European Addiction Severity Index

GAF Global Assessment of Functioning

GAS Global Adjustment Scale

GSA Global Social Adjustment

GSI Global Symptom Index

HADS Hospital Anxiety and DepressionScale

HAM-D Hamilton Depression Rating Scale

HARS Hamilton Anxiety Rating Scale

HSC-90 Hopkins Symptom Checklist

HSRS Health Sickness Rating Scale

ICD-10 International Classification ofDiseases 10

IGP interpersonal group psychotherapy

IQR interquartile range

IRT interpersonal reconstructivetherapy

ITT intention-to-treat

LAAM levo-alpha acetyl methadol

LOS length of stay

LPC Lifetime Parasuicide Count

MACT manual-assisted cognitivebehavioural therapy

MBT mentalisation-based partialhospitalisation

NA not applicable

NICE National Institute for Health andClinical Excellence

NR not reported

ns not significant

OBI Objective Behaviours Index

ONS Office for National Statistics

PD personality disorder

PDE Personality Disorders Exam

PDQ Personality Diagnostic Questionnaire

PH partial hospitalisation

PHI Parasuicide History Interview

POPMACT Prevention of Parasuicide byManual-Assisted CognitiveBehaviour Therapy

PS parasuicide

PSA probabilistic sensitivity analysis

QALY quality-adjusted life-year

RCT randomised controlled trial

SAS Social Adjustment Scale

SCID Structured Clinical Interview forDSM

SCL-90-R Symptom Checklist 90–Revised

SD standard deviation

SE standard error

SFQ Social Functioning Questionnaire

SHI Social History Interview

SSRI selective serotonin reuptakeinhibitor

TAU treatment as usual

TFT transference-focused therapy

TLFB Timeline Follow-Back

Glossary and list of abbreviations

All abbreviations that have been used in this report are listed here unless the abbreviation is well known (e.g. NHS), or it has been used only once, or it is a non-standard abbreviation used only in figures/tables/appendices in which case the abbreviation is defined in the figure legend or at the end of the table.

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ix


BackgroundBorderline personality disorder (BPD) is a severeand complex mental disorder characterised bypervasive instability in moods, interpersonalrelationships, self-image and behaviour. In theDSM-IV system, the criterion for a diagnosis ofBPD is five of nine presenting symptoms. TheOffice for National Statistics 2000 survey ofpsychiatric morbidity in private householdsidentified seven people per 1000, which indicatesthat for a primary care trust of 500,000, therewould be 3500 individuals meeting the criteria for BPD.

Psychological therapies for BPD have many factorsin common, such as a high level of structure,consistency, theoretical coherence, taking accountof the relationship problems (including thedifficulty in engaging positively with thetherapist), and taking a flexible and individualisedapproach to care. Within these general principles,several specific therapies have been applied to,and developed for use with, patients with BPD.Mental health practitioners specifically trained inthe methods described deliver these treatments.The practitioners may have a qualification inpsychiatry, mental health nursing, clinicalpsychology or another mental health profession(e.g. occupational therapy or mental health socialwork).

ObjectiveThe aim of this project was to summarise theavailable evidence on the clinical effectiveness andcost-effectiveness of psychological therapiesincluding dialectical behaviour therapy (DBT) forBPD.

More specifically, the review aimed to:

● evaluate clinical effectiveness in terms ofreductions in self-harm and suicide

● evaluate effectiveness in terms of improvedpsychological functioning (e.g. in terms ofdissociation and mood)

● evaluate effectiveness in terms of interpersonaland social functioning

● evaluate effectiveness in terms of quality of life

● evaluate effectiveness in terms of presentationto mental health and other services (includingaccident and emergency attendance andpsychiatric hospital admission)

● evaluate the cost-effectiveness of the therapiescompared with treatment as usual

● identify the important areas of ignorance oruncertainty.

MethodsClinical effectivenessA systematic review of the literature aimed toidentify all references related to the clinical andcost-effectiveness of psychological therapiesincluding DBT for BPD.

Twenty electronic bibliographic databases weresearched, covering biomedical, health-related,science and social science literature. In addition,attempts were made to identify ‘grey’ literature bysearching appropriate databases (e.g. HealthManagement Information Consortium, Index toTheses, Dissertation Abstracts), current researchregisters (e.g. National Research Register, CurrentControlled Trials) and the Internet (e.g. bysearching Google and relevant websites, such asthe British Association for Behavioural andCognitive Psychotherapies, British PsychologicalSociety and Royal College of Psychiatry). Citationsearches of included studies were undertakenusing the Science Citation Index and SocialSciences Citation Index citation search facility, andthe reference lists of included studies and relevantreview articles were also checked.

The study quality of relevant studies was assessed using standard checklists and data wereabstracted by two reviewers using standardisedforms.

Cost-effectivenessThe cost-effectiveness assessment was in two parts.The first was a review of the literature. The secondwas an original assessment undertaken by thereview team using evidence from the clinical trialsand other sources.

Executive summary

x

It was not possible to apply a formal decisionmodelling approach given the complex carepathways for patients with BPD and the lack ofevidence. It was decided instead to undertakeseparate economic evaluations for the sixrandomised controlled trials (RCTs) that hadsufficient data using a combination of datareported in published papers, trial data sets sentby the investigators, a cost model using data fromthe POPMACT study and a utility mappingexercise. Cost-effectiveness was assessed in termsof cost per parasuicide event avoided in all sixtrials and cost per quality-adjusted life-year(QALY) in four of them, (which was done bymapping BDI results onto the EQ-5D for three.All results are at 2003–4 prices and for 12 monthsfollow-up.

ResultsNumber and quality of studies, anddirection of evidenceClinical effectivenessTen studies met the inclusion criteria of DBT,mentalisation-based partial hospitalisation (MBT),manual-assisted cognitive behavioural therapy(MACT), comprehensive validation therapy (CVT)and client-centred therapy (CCT), along withtreatment as usual (TAU). Of these, nine wereRCTs and one was a non-randomised comparativestudy. The quality of the studies ranged frommoderate to poor.

Cost-effectivenessThe review of published studies identified onecost-effectiveness analysis of psychological therapyfor BPD. This was based on data from an RCTcomparing DBT with TAU for the treatment ofBPD. Participants were women who were clinicallyreferred to a psychotherapy outcome study. Thereview of published studies also identified aneconomic evaluation of psychological therapies ofpartial relevance to BPD. This was a cost-effectiveness analysis of data from an RCTcomparing MACT with TAU for the treatment ofpeople with recurrent episodes of deliberate self-harm. A subgroup analysis was published but thisdid not present a full economic evaluation(although one was undertaken by the review team).

Evidence of effectivenessClinical effectivenessNine RCTs and one non-RCT of moderate to poorquality were identified in the clinical effectivenessreview. There is some evidence to support theeffectiveness of psychological therapies for BPD:

● There is some evidence that DBT is moreeffective than TAU for the treatment ofchronically parasuicidal and drug-dependentborderline women.

● There is some evidence that DBT-orientatedtherapy is more effective than CCT for thetreatment of BPD.

● There is some evidence that DBT is as effectiveas CVT with 12-Step (CVT+12S) for thetreatment of opioid-dependent borderlinewomen.

● There is some evidence that partialhospitalisation is more effective than TAU inthe treatment of BPD.

● There is good evidence that MACT is no more effective than TAU in the treatment of BPD.

● There is some evidence that interpersonalgroup therapy is no more effective thanindividual MBT for the treatment of BPD.

However, these results should be interpreted withcaution as not all studies were primarily targetedto borderline symptoms and there wereconsiderable differences in patient characteristics,comparison groups and outcomes between thestudies.

Cost-effectivenessReviewOne cost-effectiveness analysis used data from anRCT that compared DBT with TAU for thetreatment of BPD. The participants were womenwho were clinically referred to a psychotherapyoutcome study. Those receiving DBT (n = 22)incurred significantly higher psychotherapy costs,lower psychiatric inpatient costs and loweremergency room costs compared with TAU(n = 22). The two treatment groups did not differsignificantly with respect to median medical ortotal healthcare costs. The cost-effectivenessmeasures used were cost per week employed andcost per point of global adjustment, and nosignificant difference was found in either of thesemeasures for DBT compared with TAU. This studyhad limitations concerning the lack of importantcost data and the fact that it was undertaken usingdata from a small, underpowered trial with a highdropout rate.

The cost-effectiveness analysis comparing MACTwith TAU for the treatment of people withrecurrent episodes of deliberate self-harm found no significant differences between thegroups in the total costs across all patients oramong those with BPD (n = 62). The cost per 1%reduction in the proportion of patients with a

Executive summary

repeat self-harm episode was £120, with morethan a 90% chance of being cost-effective, but thisanalysis was not undertaken for the BPDsubgroup. The incremental mean effect asmeasured by EQ-5D was negative for MACT(–0.01118). The incremental cost per QALYgained from TAU was therefore £66,000, but theauthors argued that this was probably a chancefinding given that the difference in EQ-5D was notsignificant.

AssessmentIn three of the four DBT trials, the interventiondominated the control groups in terms ofparasuicide events or achieved a cost per eventavoided below £50. However, in a fourth DBT trialthe estimated cost per event avoided was £43,124.Although these studies seem favourable to DBT interms of mean incremental cost-effectiveness, theprobability of being cost-effective at £5000 perparasuicide event avoided was around just 60% ineach case. Only two DBT trials could be subjectedto a cost per QALY analysis, and for one theintervention again dominated and the other had acost per QALY of £273,801. The probabilisticsensitivity analysis showed substantial uncertaintysurrounding these results; the most favourablestudy had a probability of DBT being cost-effectiveof around 85%.

The MBT study group achieved a low cost perparasuicide event avoided, with a probability ofbeing cost-effective at £5000 per parasuicide eventavoided of 80%. While the cost per QALY wasmodest at £7242, there was substantial uncertainty,with a probability of being cost-effective at£20,000 per QALY of less than 60%. For thePOPMACT, the BPD subgroup analysis found thatthe intervention was dominated in terms of costper parasuicide event avoided. There was aninsignificant incremental QALY gain in BPD, withan associated cost per QALY of £84,032. Theseassessments of MACT were both associated with ahigh degree of uncertainty, where the probabilityof being cost-effective was less than 50% in eachcase.

These assessments must be viewed with great care.The trials on which they were based were often ofpoor quality, using a mixture of methods forcosting and assessing outcome (including QALYs)and of doubtful generalisability to the NHS formany of the studies. This mixture of results, highlevels of uncertainty and the limitations inmethods provides very limited support for thecost-effectiveness of DBT, but the results suggestthat DBT could be cost-effective.

ConclusionsThe overall efficacy of psychological therapies ispromising; however, at this stage the evidence isinconclusive.

This study attempted to examine the cost-effectiveness of the intervention in six RCTs. Themixture of results for the four trials of DBT, plusthe high levels of uncertainty and the limitationsof the analyses, do not support the cost-effectiveness of DBT, although they suggest that it could have the potential to be cost-effective.The results for MBT are promising, althoughagain surrounded by a high degree of uncertainty, and for MACT, the analysis suggeststhat the intervention is unlikely to be cost-effective. There is a need for considerable research in this area.

Recommendations for researchThe results from existing studies in this field haveproduced a body of evidence that has been largelyinconclusive. BPD is an important condition with anumber of resource-intensive therapies availableand it should be a priority area for future research.Suggestions for further research in terms ofpragmatic trials and studies to inform economicevaluation are presented below.

Pragmatic controlled trialsAppropriately powered head-to-head RCTs ofpsychological therapies are needed. The keyfeatures of these trials include:

● Where possible, a trial should have more thanone psychological therapy being compared.

● Studies must be designed with adequatestatistical power taking into account expecteddropouts.

● Patients from a variety of ethnic and socio-economic backgrounds must be included, withan age and gender mix comparable to thosereceiving treatment on the NHS.

● The level of severity and dysfunction must bewell defined.

● The definition of ‘dropout’ must bestandardised and reduced where possible in theRCTs examining psychological therapies forBPD. Where patients drop out of therapyconsiderable effort must still be undertaken tocollect data on them.

● The different therapies need to be properlydescribed, including a TAU arm (e.g.medication must be taken into account).


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● The longest follow-up has been for 18 months,and 6 months was more common. Given thehigh cost of the interventions, longer termfollow-ups should be undertaken.

● Data should be collected on outcomes,including recognised generic measures ofhealth-related quality of life, includingpreference-based measures to permitcomparisons across programmes (see below).

● Data should be collected on resource-useservices (see below).

● Research teams should include independentresearchers.

Studies to inform future economicanalyses● A survey of current practice and the use of the

full range of services (including number of

sessions attended and type of therapist) bypeople with BPD is needed to inform futureeconomic analyses.

● Full resource-use data must be collected in thecontext of pragmatic clinical trials.

● A psychometric assessment is needed of thevalidity of the EQ-5D and other genericpreference-based measures in BPD.

● If the generic measures are found wanting, thena more condition-specific preference-basedmeasure that captures the impact of BPD onpeople’s lives should be developed.

● A more formal cost-effectiveness model needs tobe developed using the above data.

Executive summary

xii

Borderline personality disorder (BPD) is asevere and complex mental disorder

characterised by pervasive instability in moods,interpersonal relationships, self-image andbehaviour. There are several psychologicaltherapies, including dialectical behaviour therapy(DBT), and there is an emerging evidence base ontheir efficacy. The aim of this project is tosummarise the available evidence on theeffectiveness and cost-effectiveness ofpsychological therapies including DBT for BPD.

More specifically, the review aims to:

● evaluate clinical effectiveness in terms ofreductions in self-harm and suicide

● evaluate effectiveness in terms of improvedpsychological functioning (e.g. in terms ofdissociation or mood)

● evaluate effectiveness in terms of interpersonaland social functioning

● evaluate effectiveness in terms of quality of life● evaluate effectiveness in terms of presentation

to mental health and other services includingaccident and emergency (A&E) attendance andpsychiatric hospital admission)

● evaluate cost-effectiveness of the therapiescompared with treatment as usual (TAU)

● estimate the possible overall cost in Englandand Wales.

● identify the important areas of ignorance oruncertainty.

In undertaking to achieve the above aims thereview will consider factors such as the setting andprocess of therapy, including the professionalbackground of therapists involved, impact on theuse of other services, co-morbidity, and co-medication and patient characteristics includingchronicity and severity of the condition. Therapieswill be compared against any control orcomparator.


1


Chapter 1

Aim of the review

Description of underlying healthproblemBPD, one of nine or ten personality disorderdiagnoses [according to International Classificationof Disease-10 (ICD-10) or Diagnostic andStatistical Manual of Mental Disorders IV (DSM-IV)], is characterised by instability of self-image,interpersonal relationships and mood. The personhas an uncertain sense of identity, feelings of inneremptiness and often a fear of being alone.Interpersonal relationships tend to be intense butstormy, and there may be an intense fear ofabandonment and strenuous efforts to avoidabandonment, real or imagined. The person hasdifficulty regulating their emotions, with extremeand sudden shifts of mood to intense depressionor anxiety, often lasting for a few hours. Theindividual may be prone to respond to somesituations with intense anger, or with impulsive,often self-harming, behaviour. Under stress, theperson may dissociate or become paranoid. Self-harm can include attempted suicide, overdosingor self-mutilation (e.g. through cutting or burning).

EpidemiologyThe classification of personality disorders remainscontroversial and the borderline diagnosis inparticular has been criticised on scientificgrounds.1 There are high levels of co-morbiditybetween different personality disorder diagnosesand difficulties in reliable assessment, factors thatshould be taken into account when consideringepidemiological estimates.

Prevalence data for the UK are available from theOffice for National Statistics (ONS) 2000 survey ofpsychiatric morbidity in private households. Thissurvey suggests that the prevalence of borderlinedisorder was 7 per 1000, which indicates that for aprimary care trust serving a population of 175,000there would be 1250 individuals meeting thecriteria for BPD.

The ONS survey can be compared withinternational estimates of prevalence. Thesesuggest a greater prevalence of BPD in women,but the ONS survey found lower rates for women(4 per 1000 women compared with 10 per 1000men). This discrepancy may reflect differences in

sampling and instrumentation, and it is possiblethat the excess prevalence in women has beenoverestimated in some studies. An implication forresearch is that findings from intervention studieswith all-women samples may not generalise to thefull population.

The overall prevalence in the UK study is at thelower end of the range of 0.7–4.6% reported inother studies.2–7

AetiologyThe cause of BPD is complex, with adverseexperiences in childhood, such as neglect andabuse, including sexual abuse,8–11 interacting witha genetic predisposition for emotionaldysregulation.12,13

PrognosisEarly studies suggested that over 5-year follow-up,symptomatic patterns change little,14–16 but that bymiddle age, many people will no longer meet BPDcriteria, mainly through a reduction in impulsivity,self-harm and aggression, although otherborderline features, such as inner emptiness andaffective instability, may continue.17–19

More recent studies suggest that this may be toonegative a picture, with 75–80% losing the diagnosisover 4–10 years of follow-up.20–22 There has beenreplication of the finding that the change is in thebehavioural and reactive criteria such as self-harm,rather than in negative affectivity and anger.23

Significance in terms of ill-healthBPD represents a significant burden of ill-health,with reduced levels of functioning, difficultymaintaining relationships, difficulty maintainingemployment, high levels of service use, includingattendance at A&E departments and admission topsychiatric hospitals, and rates of suicide morethan 50 times higher than in the generalpopulation.13,21,24,25

Description of new interventionIdentification of patients and subgroupsThere are wide variations in presentation and inseverity. In the DSM-IV system, the criterion for a


3


Chapter 2

Background

diagnosis of BPD is five of the following ninepresenting symptoms:

● inappropriate intense anger or difficultycontrolling anger

● chronic feelings of emptiness● affective instability● transient stress-related paranoid ideation or

severe dissociative symptoms ● identity disturbance: striking and persistent

unstable self-image or sense of self● recurrent suicidal behaviour, gestures or threats;

or self-mutilating behaviour● impulsivity in at least two areas that are self-

damaging that do not include suicidal or self-mutilating behaviour

● frantic efforts to avoid real or imaginedabandonment

● a pattern of unstable and intense interpersonalrelationships characterised by alternatingbetween extremes of idealisation anddevaluation.

This means that two individuals may meet criteriafor the disorder with only one of five symptoms incommon. The implications of this for research areimportant, as some treatments [e.g. DBT, manual-assisted cognitive behavioural therapy (MACT)]were primarily developed for deliberate self-harm(DSH), which although commonly found, isneither a necessary nor a sufficient criterion forthe diagnosis of BPD. In addition, the wide rangeof possible presentations means that interventionsfor BPD are complex, which generates problemsin designing research and interpreting findings.

Criteria for treatmentIn addition to meeting criteria as above, allpsychological therapies rely on a minimumwillingness to attend regular sessions and form aworking relationship with the therapist. For peoplewho have severely problematic drug or alcoholdependence, coexisting psychotic symptoms, severeand intense suicidal behaviour or intellectualimpairment, this may not be possible.

InterventionPsychological therapies for BPD have many factors in common, such as a high level ofstructure, consistency, theoretical coherence, andtaking account of the relationship problems(including the difficulty in engaging positivelywith the therapist), and taking a flexible andindividualised approach to care. Within thesegeneral principles, a number of specific therapieshas been applied to, and developed for use with,patients with BPD.

Psychodynamic therapies used with BPD includetransference-focused therapy (TFT26) andmentalisation-based therapy.27 Cognitive andbehavioural approaches include DBT,28 schema-focused therapy,29 and MACT30 [an adapted formof cognitive behavioural therapy CBT)].31

Integrative (relational) approaches includecognitive analytic therapy32 and interpersonalreconstructive therapy (IRT). Evidence fromrandomised trials has not yet been published forall of these modalities, and the interventionsdescribed here are those for which trial data arereported, namely DBT, MACT and mentalisation-based partial hospitalisation (MBT).

DBTDBT33 was developed for women who self-harm.Five stages of treatment are outlined, but mostliterature and all research focuses on stage 1, whichaims to help the patient to develop motivation tostay in treatment and achieve behavioural controlover urges to self-harm. Weekly individual therapyand a weekly psychoeducational and skills traininggroup are offered concurrently over 1 year. Theaim is to achieve behavioural control, stability andconnection with the care provider. Patients move tothe second stage (emotional experience andreprocessing of past trauma) when behaviouralcontrol has been achieved. The key principles oftreatment include moving flexibly betweenacceptance and validation and behavioural changestrategies; this includes behavioural analysis,solution analysis and strategies, skills training,contingency management, exposure, cognitivemodification and psychoeducation. The DBTpackage also includes weekly supervision andconsultation meetings for the therapists, who workas a team, and telephone consultation, wheretherapists are available to patients outside officehours for coaching.

MACTMACT therapy30 was developed as a public healthintervention for the large numbers of people whorepeatedly attempt suicide (parasuicide) ratherthan for BPD per se. However, a high proportionof people in this population meet criteria for BPD,and this subpopulation is therefore similar to thatfor which DBT was developed. The intervention isa brief, cognitively orientated and problem-focused therapy comprising up to five sessionswithin 3 months of an episode of self-harm, withthe option of a further two booster sessions within6 months. Bibliotherapy, in the form of a 70-pagebooklet, is used to structure the treatment sessionsand to act as an aide-mémoire between sessions. Themanual covers an evaluation of the self-harm

Background

4

attempt, crisis skills, problem solving, basiccognitive techniques to manage emotions andnegative thinking, and relapse prevention strategies.

MBTMBT27 also termed psychoanalytically orientatedpartial hospitalisation, is based on anunderstanding of BPD as a disorder of the selfresulting from a failure in mentalisation, withintervention aimed at increasing the self-reflectivecapacity of the patient. Treatment is in the contextof a day hospital and comprises many elements,including weekly individual therapy, thrice-weeklygroup analytical therapy, weekly expressivetherapy with psychodrama and a weeklycommunity meeting, for a maximum of18 months.

Personnel involvedThese treatments are delivered by mental healthpractitioners specifically trained in the methodsdescribed. The practitioners may have aqualification in psychiatry, mental health nursing,clinical psychology or other mental healthprofession (e.g. occupational therapy, mentalhealth social work). Training routes vary, but afterthe core professional qualification, usually involvea 1- or 2-year part-time course followed bysupervised practice.

Current evidenceTwelve systematic reviews reporting at least someinformation regarding BPD, personality disorder,DSH and suicide attempters as populations andpsychological treatments as interventions wereidentified (Table 1). They were aimed either atbroad strategies such as dissemination ofguidelines34–37 or at particular target groups andproblem areas related to personality disorders.38–45

Most primary studies were included in more thanone review. There was a lack of common approachaccepted between the reviews and the inclusionand exclusion criteria varied considerably.Interventions were classified differently indifferent systematic reviews. The characterisationof BPD was also complicated. Because the BPD isa subcategory of personality disorder withDSH/suicide attempts as a main feature, thereviews on personality disorders and DSH ofteninclude borderline patients and there are very fewreviews conducting BPD subgroup analyses orreviews on BPD on its own.

No systematic reviews published before 1997 wereidentified. Four reviews conducted meta-analyses

of the results of the studies identified.36,38,39,40

Because of the broad inclusion criteria andheterogeneity of the studies included in thereviews the appropriateness of meta-analyses isuncertain. Table 1 presents the overlap ininformation of identified systematic reviews.Among the reviews only one high-qualitysystematic review38 was designed to look at studieson BPD. This review was completed by theCochrane Collaboration on behalf of the NHSNational R&D Programme on Forensic MentalHealth, UK. The authors were contacted and gavetheir permission for the review to be used in thisreport before its official publication. The reviewerssearched large number of electronic databasessupplemented by citation tracking of includedarticles and keywords. Only published data wereincluded in this review.

To assess the effectiveness the authors limited thetype of study to randomised controlled trials(RCTs). The quality of studies was assessedaccording to the Cochrane CollaborationHandbook46 and only trials in category A and Bwere included. The outcomes were data fromassessment scales such as global state, behaviourand mental state. The engagement with services,satisfaction with treatment, acceptance oftreatment and quality of life were also assessed.Meta-analyses were performed on relevantoutcomes using a random effects model. Theauthors described in detail the methods of testingheterogeneity and sensitivity analyses. Although awide range of psychological therapies is used totreat BPD, many were omitted from the reviewowing to a lack of RCT evidence.

The review by Adams and colleagues38 suggeststhat some problems of BPD patients may betreated by behavioural therapies. However, theauthors note that all reviewed therapies arecurrently at the experimental stage and thenumber and size of the trials are too small to cometo clear conclusions.

The scope of Adams’ review38 overlapped with thecurrent review in all aspects of inclusion criteria.Trials identified by Adams and colleagues38 arealso included in the current review and describedin the section ‘Results’ (p. 8). The populations,interventions and outcomes of the Adams review38

were compared with the scope of the present HTAreview to assess the degree of overlap and identifyareas not covered. The current review differs inthat non-RCT evidence is also included.


5


Background

6

TABLE 1 Summary of systematic reviews of BPD

Study Type of Condition Psychological BPD Main outcomeevidence therapy reported

intervention

RCT Non- PD DSH BPDRCT

Binks et al., 2005 Yes – – – Yes Yes Yes Improvement of (NHS National R&D symptoms Programme on Forensic Suicide and repetition of Mental Health)38 DSH

Treatment retentionTreatment duration

Bateman and Fonagy, Yes Yes Yes Yes Yes Effectiveness of the 200045 treatment

Boyce et al., 2003, Yes Yes – Yes – Yes Yes Improvement of (Australian and New symptomsZealand clinical practice Suicide and repetition of guideline)34 DSH

Cornah et al., 1997 – Yes – – Yes Therapeutic Yes Improvement of (NHS R&D Directorate community symptoms Report)37 Effectiveness of

therapeutic community

Hawton et al., 199839 Yes – – Yes – Yes Yes Improvement ofsymptomsSuicide and repetition ofDSH

Lees et al., 1999 Yes Yes Yes – – Therapeutic Yes Improvement of (NHS, CRD Report)36 community symptoms

Effectiveness oftherapeutic community

Leichsenring, 200242 Yes Yes Yes – – Psychodynamic Yes Effectiveness of therapy psychodynamic therapy

Perry et al., 199941 Yes Yes Yes – – Yes Yes Improvement ofsymptomsTreatment retention Treatment duration

Sanislow and McGlashan, – Yes Yes – – Yes Yes Effectiveness of the 199843 treatment

Van der Sande et al., 199740 Yes – – Yes – Yes Yes Suicide and repetition ofDSHEffectiveness of therapy

Warren et al., 2003 Yes Yes Yes – – Yes Yes Improvement of (Home Office Report)35 symptoms

Suicide and repetition ofDSHTreatment retention Treatment duration

Woods and Richards, 200344 Yes Yes Yes – – Nursing Yes Effectiveness of nursing interventions

CRD, Centre for Reviews and Discrimination; PD, personality disorder.

Methods for reviewingeffectivenessIdentification of studiesAim of the search strategyOne set of searches was undertaken to inform thereview of clinical effectiveness. The aim of thesesearches was to identify all studies relating topsychological therapies for BPD. A second set ofsearches was undertaken to inform the twoeconomic aspects of the assessment. The scope ofthese searches was broader, to satisfy the inclusion criteria of the cost-effectiveness reviewand to inform the broader requirements of theeconomic assessment. The aim of these searchestherefore was to identify all economic studiesrelating to BPD (i.e. not restricted byintervention).

Sources searchedTwenty electronic bibliographic databases weresearched, providing coverage of the biomedical,health-related, science, social science and greyliterature (including theses and conferenceabstracts). The publications lists and currentresearch registers of health services research, social care and mental health organisations were consulted via the World Wide Web. Keyword searching of the World Wide Web wasundertaken using the Google search engine. The reference lists of included studies andrelevant review articles were also handsearched. A list of the sources searched is provided inAppendix 1.

Search termsSensitive keyword strategies using free-text and,where available, thesaurus terms were developedto search the electronic databases. The selection ofkeywords was informed by DSM-III, DSM-IV, ICD-10 and clinical members of the assessment team.For the review of clinical effectiveness synonymsrelating to the intervention (e.g. psychologicaltherapies, dialectical behaviour therapy) werecombined with synonyms relating to thepopulation (e.g. borderline personality disorder,Axis II, Cluster B). For the economic searchessynonyms relating to the population only wereused. Keyword strategies for all electronicdatabases are provided in Appendix 2.

Search restrictionsThe clinical effectiveness searches were notrestricted by terms relating to study design. Theeconomic searches were restricted by termsrelating to cost and economics. The search ofPubMed was restricted to the last 180 days tocapture recent and unindexed MEDLINE records.Date limits were not used on any other database.Language restrictions were not used on anydatabase. Searches were undertaken in March 2005.

Inclusion and exclusion criteriaEligibility for this review was determined by thefollowing criteria:

● participants: adults with BPD (diagnosedaccording to DSM-III/DSM-III-R, DSM-IV orICD-10 criteria for BPD), with or without co-morbidity; studies on people with anypersonality disorder and DSH were alsoincluded, where subgroup analysis of BPD wasavailable

● intervention: psychological therapies, includingDBT

● comparators: any psychiatric or psychologicaltreatment, or no treatment

● outcomes: self-harm, suicide, interpersonal andsocial functioning, crisis presentations to mentalhealth services, quality of life, patient preference,satisfaction, acceptability of treatment and cost

● study type: published papers were assessedaccording to the accepted hierarchy of evidence,whereby systematic reviews of RCTs are taken tobe the most authoritative forms of evidence,with uncontrolled observational studies the leastauthoritative

● exclusion criteria: papers on personalitydisorder and DSH without separate BPDsubgroup analyses.

Figure 1 shows a summary of study selection andexclusion.

Quality assessment strategySystematic reviews were assessed according to theUsers’ guides to evidence-based practice.47 Thequality of RCTs was assessed using the CriticalAppraisal Skills Programme (CASP) checklist forappraising RCTs (http://www.phru.nhs.uk/casp/rcts.htm). The ten questions in CASP tool are


7


Chapter 3

Effectiveness

adapted from the users’ guides to the medicalliterature.48,49

The non-randomised study using quantitative datawas assessed with respect to validity using theCASP checklist for cohort studies(http://www.phru.nhs.uk/casp/cohort_studies.htm).It contains 12 questions for assessing the types ofstudy in terms of their validity, results andapplicability. The quality of the economicliterature was assessed according to the Guidelinesfor authors and peer reviewers of economicsubmissions to the BMJ.50

Key components of quality assessment are listed inAppendix 3 (Tables 18 and 19).

Data extraction strategyData were extracted by one researcher and checkedby another using the Reference Manager database.Any disagreements were resolved by discussion.The authors aimed to cover as many as possible

types of psychotherapy and find the best availableevidence on each treatment. Where there were noRCTs available on a certain type of intervention,lower level (comparative) studies were considered.

Data synthesisThe suitability of pooling data across studies wasassessed by examining study populations,comparators, outcomes and study type. Studieswere found to be too heterogeneous in theserespects for meta-analysis to be appropriate, and itwas not undertaken. The results are thereforepresented in tabulated format with narrativesynthesis of the results.

ResultsQuantity and quality of researchavailableTen trials were identified, of which nine wereRCTs and one was a non-randomised trial. Table 2

Effectiveness

8

Potentially relevant papersidentified and screened forretrievalRCT n = 1216Non-RCT n = 2455

Total abstracts screenedRCT n = 226Non-RCT n = 763

Papers rejected at titleRCT n = 990Non-RCT n = 1692

Papers rejected at abstractRCT n = 145Non-RCT n = 724

Rejected full paperRCT n = 72Non-RCT n = 38

Total full papers screened (plusfrom other sources)RCT n = 81Non-RCT n = 39

Studies included in this reviewRCT n = 9Non-RCT n = 1Total n = 10

FIGURE 1 Summary of study selection and exclusion

summarises the studies included in this review.(Excluded studies are listed in Appendix 4.)

Appendix 3 contains the evidence tables with dataextracted from the ten studies included in thisreport. RCTs and non-randomised trials arepresented in separate tables.

Study characteristicsStudy characteristics for the ten studies aredescribed in Appendix 3 (Tables 18 and 19).

Description of psychotherapiesRCTs The studies report problem-focusedpsychotherapies administered in the outpatient


9


TABLE 2 Studies included in the review

Study Sample Intervention Comparator Population Primary outcome size

RCTsBateman and 38 PH TAU Patients with severe Effectiveness of psychoanalytically Fonagy, 199951a parasuicidal BPD orientated PH for the BPD

symptoms

Koons et al., 20 DBT TAU Women Veterans Effectiveness of DBT for the 200157 with BPD treatment of BPD

Linehan et al., 44 DBT TAU Chronically Effectiveness of DBT for the 199153a parasuicidal women treatment of BPD women with

with BPD BPD

Linehan et al., 28 DBT TAU Substance abusing Effectiveness of DBT for the199954 women with BPD treatment of drug-dependent

women with BPD

Linehan et al., 23 DBT CVT+12S Heroin-dependent Effectiveness of DBT for the 200255 women with BPD treatment of heroin-dependent

women with BPD

Munroe-Blum 48 Time –limited Individual Patients with BPD Effectiveness of IGP for the and Marziali, (psychodynamic) psychotherapy treatment of BPD199556 IGP

Turner, 200057 24 DBT-orientated CCT Patients with BPD Effectiveness of a DBT-orientated therapy therapy for BPD

Tyrer et al., 480 MACT TAU Patients with Effectiveness of MACT in 200358a (PD recurrent DSH reduction of depressive

n = 391 (including BPD) symptoms and the rate of BPD parasuicide eventsn = 67)

van den Bosch 34 DBT TAU Female borderline Effectiveness of the DBT for the et al., 200259a patients with or BPD and substance use problems

without co-morbid substance abuse

Non-RCTWilberg et al., 43 Day hospital Day hospital Patients with BPD Effectiveness of the day treatment 199860 treatment (TAU) treatment with subsequent outpatient

plus post- (TAU) group therapy for the BPDdischarge group analytical therapy

a The follow-up and other relevant studies were assessed as part of the main studies, and only the main paper is cited in thecurrent report. All other relevant references can be found from the reference list. Linehan et al. (1993)61 was the 12-month post-treatment follow-up report of Linehan et al., (1991)53 and Bateman and Fonagy (2001)62 was the 18-monthpost-treatment follow-up report of Bateman and Fonagy (1999).51 Tyrer et al. (2004)63 was part of Tyrer et al. (2003)58

and Verheul et al. (2003)64 was included as part of van den Bosch et al. (2003).59

CVT+12S, comprehensive variation therapy with 12-Step; IGP, interpersonal group psychotherapy; PH, partialhospitalisation.

setting using various methods. Five RCTs, byLinehan,53–55 Koons52 and van den Bosch andcolleagues,59 assessed the effectiveness of DBT, thetherapy that balances problem-orientatedtechniques with supportive techniques such asreflection, empathy and acceptance of patient’sinherent ability. One RCT57 used a form ofintegrative therapy based on DBT, wherepsychodynamic techniques were incorporated toconceptualise patients’ behavioural, emotional andcognitive relationship schema and the skillsgroups were omitted. Instead, group sessions inboth the treatment and control groups emphasisedinterpersonal relationships. One trial51 used thepsychoanalytically orientated partialhospitalisation method, where the partiallyhospitalised group received a combination ofindividual and group MBT along with communitymeetings. One trial56 looked at the time-limitedgroup therapy approach, which addresses theinterpersonal problems and focuses on observingand processing the meaning of within-therapyenactment of interpersonal communication andbehaviour, among patients and between patientsand co-therapists. One RCT58 on DSH usedMACT, where patients were given a bookletcovering problem solving, basic cognitivetechniques to manage emotions, negative thinkingand relapse prevention strategies.

Non-RCT The study by Wilberg and colleagues60

used day hospital treatment followed bypostdischarge, group analytical therapy.

Study qualityRCTs The quality of RCTs was assessed using theCASP checklist for appraising RCTs(http://www.phru.nhs.uk/casp/rcts.htm), whichcovers five main categories: randomisationmethod (description of the randomisationmethod), blinded assessment, power calculation,reason for loss for follow-up and intention-to-treat(ITT) analysis (Table 3).

Because people with BPD have difficulty formingand sustaining collaborative interpersonalrelationships, psychological therapy is oftendifficult to deliver. A high dropout rate, failure to meet power calculation estimates andimpossibility of blinding are typical for the studies examining psychological interventions, and assessment of their quality with the standardcriteria seems inadequate. Therefore, the authors used an additional modified Lackner’schecklist based on the Cochrane CollaborationDepression and Anxiety Neurosis Review Group (CCDAN) scale, which covers a wider areaof design issues specifically for psychologicalstudies.

Lackner and colleagues65 adapted the CCDAN 23-item coding scheme (CCDAN criteria are onwww.iop.kcol.ac.uk/IoP/ccdan/index.htm)specifically to rate the methodological quality ofpsychological treatment trials. They incorporatedsix additional items into the measure, so that thefinal 29-item coding scheme reflected both

Effectiveness

10

TABLE 3 Study qualities assessed using the CASP checklist

Study Description of Blinded Power Reason for ITTrandomisation assessment calculation loss to

method follow-up

Bateman and Fonagy, 199951 N NR N N N

Koons et al., 200152 N NR Y Y N

Linehan et al., 199153 Y Blinded independent assessor N Y N

Linehan et al., 199954 Y Blinded independent assessor N N Y

Linehan et al., 200255 Y Blinded independent assessor N N Y

Munroe-Blum and Marziali, Y NR Y N N199556

Turner, 200057 N Blinded independent assessor N N Y

Tyrer et al., 200358 Y NR Y Y Y

van den Bosch et al., 200259 Y Independent assessora N Y Y

a Independent assessors were not informed about the treatment condition of the interviewees; however, patients mighthave given the information about treatment.

N, no; NR, not reported; Y, yes.

general, evidence-based medicine guidelines forrating the quality of clinical trials (e.g. post-treatment follow-up for all groups, declaredallegiance or therapy, avoidance or equality of co-interventions) and recommendations.

Appendix 3 (Tables 18 and 19) and Appendix 5show quality scores for each of the trials. All trialswere described as randomised with treatmentlasting from 6 months52 to over 18 months,51 andall trials except for Turner57 and Munroe-Blumand Marziali56 gave a description of therandomisation method. No studies were doubleblind. It is impossible to blind patients andtherapists in psychological treatments as both areaware that therapy is taking place. Therefore,assessments were conducted by independentassessors who were not aware of patients/treatmentconditions. Only three trials52,56,58 reported thatthey did a power calculation; however, the samplesizes were too small in most of them to detect thetrue effect of the treatment. All reported thenumber of withdrawals, but only five trialsreported the reasons for dropouts.52–54,58,59

Dropout rates were high, up to one-third of thetotal sample, often with no apparent reason, withpatients starting to dropout immediately afterrandomisation and pretreatment assessment andthroughout the active treatment period and post-treatment follow-up. ITT analysis is a strategy forthe analysis of RCTs that compares participants inthe groups to which they were originally assignedincluding all patients regardless of whether theyreceived the treatment or withdrew from the trial.Clinical effectiveness may be overestimated if anITT analysis is not done.66 Three trials51–53

reported data only for completers and assumedthat patients who left the trial had poor outcomes.The rest of the studies reported the use of an ITTanalysis. Most studies had a follow-up period of atleast 4 months, except for three trials.52,57,58 Twotrials56,58 had more than 50 participants in eacharm. Most participants were women. Most of thetrials gave full demographic details. All trialsclearly reported details of the inclusion/exclusioncriteria, diagnostic criteria and therapy conditions.However, important aspects such as allocationconcealment, therapy credibility and expectancywere omitted in all studies. No trial gave detailson side-effects. All described outcome measuresclearly and/or used validated instruments, andgave sufficient information on comparability ofgroups. The presentation of results was inadequate for later data synthesis in twotrials.56,58 All trials were considered to have‘mainly appropriate’ statistics, with someexceptions, such as the inappropriate use of one-

tailed tests. Conclusions were partially justifiedand all but two51,57 acknowledged support and/orfunding sources.

Non-RCT The Wilberg study60 was a comparativestudy with an active treatment period lasting forup to 1 year and had over 50 participants in eacharm. The study60 reported some information onsocio-economic background, but unclearinformation regarding participants’ gender. Thestudy had a small sample size, different baselinecomparability between two groups andretrospective assessment of diagnoses and somemeasurements [i.e. Health Sickness Racing Scale(HSRS)], which may lead to a serious bias inmeasuring outcomes.

Co-therapy or medicationRCTs The use of co-therapies was described inmost of the studies. Participants from the trialsconducted by the Linehan group53–55 aimed toterminate, taper off or replace psychotropicmedications. One trial51 reported thatpolypharmacy was discouraged, three trials52,57,59

reported the type of pharmacotherapy used byparticipants, and two trials56,58 did not provideany information about co-therapy.

Non-RCT Wilberg and colleagues60 did notreport co-therapy administration.

ComparatorsRCTs Six trials had TAU as a comparator,although the TAU was not always clearlydescribed. Koons and colleagues52 described TAUas 60 minutes of weekly individual therapy. Allpatients were additionally offered one or more ofseveral supportive and psychoeducational groups.Linehan and colleagues53 report that patients inthe TAU group were given alternative referrals.Nine patients received individual psychotherapyfor an average of 34.87 hours. The TAU conditionwas naturalistic and allowed participation in anytype(s) of therapy available in the community.Linehan and colleagues67 referred TAU patients toalternative substance abuse and mental healthcounsellors and programmes in the community, orthey continued their existing treatment. Van denBosch and colleagues59 report that TAU consistedof principal management from the originalreferral source: addiction treatment centre,psychiatric services with no more than two sessionsper month with a psychologist, psychiatrist orsocial worker. Tyrer and colleagues,63 report thatTAU patients were offered the standard treatmentin the area concerned or the continuation ofexisting treatment. This varied from problem-


11


solving approaches, through dynamicpsychotherapy, GP or voluntary group referral, toshort-term counselling.

According to Bateman and Fonagy51 TAU consistsof general psychiatric services with regularpsychiatric review, hospitalisation as appropriatewith treatment focused on problem solving andoutpatient community follow-up. One trial55 onheroin-dependent women with BPD hadCVT+12S as a control therapy. CVT+12S isdesigned to control for provision of support,validation and general therapeutic acceptance,and other components of treatment not coveredby DBT. One trial57 used client-centred therapy(CCT). CCT is the model of supportive therapybased on Carkhuff ’s model,114 which emphasisesempathic understanding of the patient’s sense ofaloneness and provides a supportive attitude onan individual basis. One study56 used an individualdynamic psychotherapy as a comparator, which isopen-ended, individual therapy.

Non-RCT The Wilberg60 study design was TAUplus postdischarge group analytical therapy versusTAU, with TAU being day hospital treatment.Some of the control group participants wereuntreated postdischarge. Thus, in reported trialsmembers of the control group were not receivingthe same care.

Sample sizeRCTs Sample sizes were generally small (lessthan 50). Only two trials56,58 included more than100 patients. Three studies51,53,57 included from30 to 60 patients, and four trials52,54,55,57 hadfewer than 30 participants. Although threestudies52,56,58 reported a power calculation beingused to determine sample size, only two ofthese56,58 reached adequate power.

Non-RCT In the Wilberg trial60 the sample sizewas small (less than 50 in each arm).

Therapy detailsAppendix 3 describes the details of therapy(Tables 20 and 21).

RecruitmentRCTs Most trials recruited patients frompsychiatric hospitals or mental health centres, orpatients were referred by independent clinicians.The Linehan group55 also included participantswith substance abuse from methadonemaintenance clinics and HIV/AIDS preventionorganisations treating underserved minoritypopulations. One study57 recruited participants

from emergency services and community healthoutpatient clinics.

Non-RCT In the Wilberg study60 recruitment wasfrom patients at a day hospital.

Number and length of sessionsRCTs The number of sessions of DBT rangedfrom 48 to 56 (weekly for 1 year) according tostandard BPD treatment.53 In one study52 DBTwas administered for 6 months. A maximum of84 weekly sessions were administered for DBT-orientated therapy.57 Partial hospitalisation51 wasalso administered weekly over an average of1.45 years. Patients in IGP56 had 30 sessions(25 weekly sessions, followed by five twice-weeklysessions). The study on DSH58 reported thatpatients received six sessions according to sixchapters of the manual, but there is no indicationof the duration of the sessions.

Non-RCT In the Wilberg study60 the sessions were once a week for 1.5 hours over 1–33 months (mean length of treatment12 months).

Therapist contact between sessions andprofessional background of therapistRCTs Most studies reported that patients wereallowed to make a telephone call52–55,59 or have aface-to face57 consultation with therapists in acrisis situation. It was unclear whether there wassimilar access to therapists for comparator groups.Patients who used MACT were given the firstchapter of the manual by the therapist and in thelater sessions sought the therapist’s help only forspecific problems. More details are provided inTable 4 and Appendix 3 (Table 20). There is noinformation regarding the frequency and durationof the crisis situations and additional between-session consultations did not seem to be includedin the therapist time.

Non-RCT Therapist time was not reported.

Therapist’s professional background RCTs The therapist’s professional backgroundvaried from a psychotherapist with an average of22 years of experience57 to experienced graduatepsychology students53 and psychiatric nurseswithout a formal psychotherapy qualification.51 Allstudies report that therapists were trained in theintervention therapies. The details of thetherapists are given in Appendix 3 (Table 20).

Non-RCT In the Wilberg study60 the majority oftherapists (six out of eight) had a background in

Effectiveness

12

group analytical training. The details of thetherapists are given in Appendix 3 (Table 21).

Study site, follow-up and inclusion/exclusioncriteriaAppendix 3 (Tables 22 and 23) describes the studysite, follow-up and inclusion/exclusion criteria ofall included studies.

Study site and settingRCTs Five studies were conducted in theUSA,52–55,57 two in the UK,51,58 one in Canada,56

and one in The Netherlands.59 One of the trials58

in the UK was a multicentre RCT. In terms ofsetting, three studies were conducted in university-based research clinics,53–55 one59 wasbased in an addiction treatment centre and fivestudies took place in outpatient psychiatric units,either a hospital or a psychiatric centre.51,52,56–58

Patients in one study51 were partially hospitalised.

Non-RCT The Wilberg study60 took place inNorway and was carried out in a day psychiatricunit of a university hospital.

Follow-upRCTs The length of follow-up ranged from12 months57,58 up to 36 months51 (Table 5). Three studies52,57,58 did not follow up the patientsafter the active treatment period. Although the number of patients lost to follow-up wasreported in all trials, the reasons were not always given.55–57 Where reported, loss to follow-up was mainly caused by patients droppingout before, during or after treatment in bothgroups. Other reasons included death,54,48

distance and problems with transportation,52

refusal of treatment allocation52 or assessment.58

The non-acceptance of the treatment and/ordropout rate was relatively high, with an averageof one in three patients not completing theirtreatment.


13


TABLE 4 Therapist time

Study Psychological therapy Control therapy

RCTsBateman and Fonagy, 199951 Individual group session 1 hour per week NR

Thrice-weekly group 1 hour per weekOnce-a-week expressive therapy 1 hour per weekWeekly community meeting 1 hour per week Meeting with case administrator 1 hour per month

Koons et al., 200152 1.5 hours per week 1 hour individual sessionper week

Linehan et al., 199153 Individual session 1 hour per week Nine patients received Group session 2.5 hours per week individual psychotherapy

for an average of34.87 hours

Linehan et al., 199954 Individual session 1 hour per weekGroup session 2.5 hours per weekplus 15-minute wind-down NR

Linehan et al., 200255 Individual session 40–90 minutes per week Individual CVT+12S Group session 150 minutes per week 40–90 minutes per week

‘12-and-12’ NarcoticsAnonymous group120 minutes per week

Munroe-Blum and Marziali, 199556 30 sessions Individual session once or 25 weekly sessions for 1.5 hours twice per week. Total 5 biweekly sessions for 1.5 hours 210 hours for 30 sessions

Turner et al., 200057 NR NR

Tyrer et al., 200358 NR NR

van den Bosch et al., 200259 2–2.5 hours per week NR

Non-RCTWilberg et al., 199860 Once a week for 1.5 hours over a period of NR

1–33 months (mean 12 months)

Non-RCT Wilberg and colleagues60 reported thatthe follow-up information was available for 92% ofthe participants, of whom two were dead at follow-up, and the final results are based on 88% of theparticipants.

Inclusion and exclusion criteriaRCTs All studies clearly stated the inclusion andexclusion criteria using standardised criteria orscales for BPD. Exclusion criteria were similar inall trials and included schizophrenia, bipolardisorder, and organic mental or physicalimpairment. A primary diagnosis of alcohol anddrug addiction was also an exclusion criterion insome studies.53,56,58

Non-RCT Wilberg and colleagues60 used DSM-III/DSM-III-R criteria for BPD as inclusioncriteria.

Patient characteristicsPatient characteristics are described in Appendix 3(Tables 24 and 25).

Diagnosis of disorderAll studies reported the methods used to diagnoseBPD. The most common criteria were:

● DSM-III/DSM-III-R ● DSM-IV● Structured Clinical Interview for DSM (SCID)-I ● SCID-II● Personality Disorder Exam (PDE)● Diagnostic Interview for Borderlines (DIB)● ICD-10

● European Version of the Addiction SeverityIndex (EuroASI)

● Personality Diagnostic Questionnaire (PDQ-R).

Age, gender, ethnicity, background and patienthistoryRCTs Five studies were done only onwomen.52–55,59 The other studies also includedconsiderably more women than men. The age ofparticipants ranged between 16 and 70 years;however, the mean age was not always reported.Six trials52,54,55,57–59 reported the ethnicity,although some of them reported only thenationality of the participants. At least someinformation on education and socio-economicbackground, including level of education,employment, income, marital status and livingconditions, was reported in all but one trial.54

All studies reported explicitly the history ofpatients. The common elements in patient historyincluded history of parasuicide, psychiatrichospitalisation and alcohol or drug abuse. Twotrials51,52 reported history of childhood sexual andphysical abuse. Three studies52,54,59 reported thatpatients had a lifetime history of parasuicide. Fourtrials52,53,56,59 reported that patients had a historyof therapy or medication for BPD or otherpsychiatric problems.

Overall, the participants were mainly white,unemployed and single, and had graduated fromhigh school or college. There were, however, somedistinct differences between studies. For example,Linehan and colleagues’ 199954 study included

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TABLE 5 Study follow-up

Study Active treatment period Post-treatment follow-up Total follow-up(months) (months) (months)

RCTsBateman and Fonagy, 199951 18 18 36

Koons et al., 200152 6 No 6

Linehan et al., 199153 12 12 24

Linehan et al., 199954 12 4 16

Linehan et al., 200255 12 4 16

Munroe-Blum and Marziali, 199556 12 12 24

Turner, 200057 12 No 12

Tyrer et al., 200358 12 No 12

van den Bosch et al., 200259 12 6 18

Non-RCTWilberg et al., 199860 12 34 46

only women, who were relatively young andwealthy, whereas Bateman and Fonagy’s51

participants included men and women, who wereolder and mainly unemployed.

Non-RCT The information presented in theWilberg paper60 was unclear. However, it providedsome information on participants’ education,marital and occupational background, and data ontheir clinical history.

Baseline comparabilityRCTs All studies reported that there were nostatistically significant differences for importantvariables between two groups51,52,55–59 or thatparticipants were matched on age, severity of thesymptoms and number of psychiatrichospitalisations.53,54

Non-RCT Wilberg and colleagues60 reported thatthe control group were significantly younger thanthe treatment group and had spent less time inthe day hospital. Participants in the treatmentgroup had also been married less often than thosein the control group.

Outcomes and resultsTreatment outcome measures and instruments arepresented in Appendix 3 (Tables 26 and 27).

Outcomes to be reported in this review are:

● clinical effectiveness in terms of improvement inpsychological symptoms (parasuicide, suicidalideation, mood and emotional dysregulation)

● effectiveness in terms of interpersonal andsocial functioning (impulsive behaviour)

● effectiveness in terms of preference, satisfactionand acceptability of treatment

● effectiveness in terms of quality of life● cost (see Chapter 4).

Instruments and measurement periodsRCTs Outcomes were measured by a variety ofvalidated instruments for BPD, depression andanxiety, suicide ideation, treatment history andsocial functioning, at baseline, during and at theend of treatment. Most studies also reported theresults of post-treatment follow-up. The list of theinstruments is presented in Table 6.

Non-RCTs Outcomes were measured by a varietyof validated instruments. The list of instruments ispresented in Table 6.

Descriptions of the most common scales are asfollows.

● The Borderline Syndrome Index is a 52-itemforced choice questionnaire that measuresborderline psychopathology associated withborderline states and borderline personalityorganisation.

● The Parasuicide History Interview (PHI) is a semi-structured interview that is used to collectdetails regarding the time, circumstances,motivations and treatment of each parasuicideevent that a participant can recollect.

● The Beck Depression Inventory (BDI) is a 21-itemself-report scale used to determine depressionseverity. Items are scored on a 0–3 scale giving atotal range of 0–63. Total scores within the 1–9range indicate minimal depression, 10–18 milddepression, 19–29 moderate and 30–63 severedepression.

● The Beck Anxiety Inventory (BAI) is also a 21-itemself-report scale. Patients rate symptoms from 0to 3 according to severity. A score of 0–9 reflectsnormal levels of anxiety, 10–18 mild tomoderate anxiety, 19–29 moderate to severeanxiety and 30–63 severe anxiety.

● The Beck Hopelessness Scale (BHS) is a 20-itemtrue/false test that examines three aspects ofhopelessness: feelings about the future, loss ofmotivation and expectations. It is designed foruse with people aged from 17 to 80 years, andtakes 5–10 minutes to administer.

● The Beck Scale for Suicide Ideation is a 21-itemscale that assesses any potential suicidal intentand the severity of suicidal ideation.

● The Borderline Personality Disorder Severity Index(BPDSI) is a semi-structured interview assessingthe frequency and severity of manifestations ofBPD during a circumscribed period.

● The Hamilton Rating Scale for Depression (HAM-D, HRSD) is designed to be used on patientsalready diagnosed as suffering from an affectivedisorder of depressive type. There are 17variables measured on either a five-point or athree-point rating scale.

● The Hospital Anxiety and Depression Scale (HADS)is a self-assessment instrument for measuringdepression and anxiety independently. It wasdeveloped for use with physically ill patients. Itis limited to 14 items and scored on a four-point scale from 0 to 3.

● The Social Adjustment Scale (SAS) is a 54-itemself-report measure, using a five-point Likertscale. It is a comprehensive scale available forassessing detailed role performance within thefamily, as a parent and at work. Six major areasof functioning are covered: work (paid orunpaid), social and leisure activities,relationships with extended family, role asmarital partner, parental role and role within


15


Effectiveness

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TABLE 6 Instruments and scales used as outcome measures

Instrument Abbreviation Studies

RCTsBeck Anxiety Inventory BAI Turner, 200057

Beck Depression Inventory BDI Linehan et al., 1991;53 Koons et al., 2001;52

Bateman and Fonagy, 1999;51 Turner, 2000;57

Munroe-Blum and Marziali, 199556

Beck Hopelessness Scale Linehan et al., 1991;53 Koons et al., 200152

Beck Scale for Suicide Ideation Linehan et al., 1991;53 Koons et al., 2001;52

Turner, 200057

Borderline Personality Disorder Severity Index BPDSI van den Bosch et al., 200259

Brief Psychiatric Rating Scale BPRS Turner, 200057

Brief Symptom Inventory BSI Linehan et al., 200255

Client Service Receipt Inventory CSRI Tyrer et al., 200358

Dissociative Experiences Scale DES

Global Adjustment Scale GAS Linehan et al., 1999;54 Linehan et al., 200255

Global Assessment of Functioning GAF Linehan et al., 2002;55 Tyrer et al., 200358

Global Social Adjustment GSA Linehan et al., 1999;54 Linehan et al., 200255

Hamilton Anxiety Rating Scale HARS Koons et al., 200152

Hamilton Depression Rating Scale HAM-D Koons et al., 2001;52 Turner, 200057

Hopkins Symptom Checklist HSC-90 Munroe-Blum and Marziali, 199556

Hospital Anxiety and Depression Scale HADS Tyrer et al., 200358

Inventory of Interpersonal Problems Bateman and Fonagy, 199951

Lifetime Parasuicide Count LPC van den Bosch et al., 200259

Longitudinal Interview Follow-Up Evaluation Linehan et al., 1999;54 Linehan et al., 200255

Base Schedule

Objective Behaviours Index OBI Munroe-Blum and Marziali, 199556

Parasuicide History Interview PHI Linehan et al., 1991;53 Linehan et al., 1999;54

Linehan et al., 2002;55 Koons et al., 2001;52

Tyrer et al., 200358

Generic Health Related Qualities of Life EQ5D Tyrer et al., 200358

(EuroQol 5 Dimensions)

Social Adjustment Scale SAS Linehan et al., 1999;54 Linehan et al., 2002;55

Bateman and Fonagy, 1999;51 Munroe-Blum andMarziali, 199556

Social Functioning Questionnaire SFQ Tyrer et al., 200358

Social History Interview SHI Linehan et al., 1999;54 Linehan et al., 200254

Spielberg State–Trait Anger Expression Inventory Linehan et al., 1999;54 Koons et al., 200152

Spielberg State–Trait Anxiety Inventory Bateman and Fonagy, 199951

Structured Clinical Interviews Linehan et al., 199954

Suicide and Self-Harm Inventory Bateman and Fonagy, 199951

Survival and Coping Scale Linehan, 199153

Symptom Checklist SCL-90-R Bateman and Fonagy, 199951

Target Behaviour Ratings Turner, 200057

The Reasons for Living Inventory Linehan et al., 199153

Timeline Follow-Back TLFB Linehan et al., 200255

Treatment History Interview THI Linehan et al., 199954

Non-RCTHealth and Sickness Rating Scale HSRS Wilberg et al., 199860

Global Symptom Index GSI Wilberg et al., 199860

family unit (including perceptions abouteconomic functioning).

● The Global Assessment of Functioning (GAF) is a100-point tool rating overall psychological,social and occupational functioning of peopleaged 18 years and older. It excludes physicaland environmental impairment.

● The Global Adjustment Scale (GAS) is a 100-pointscale for measuring the overall level ofimpairment.

● The Global Social Adjustment (GSA) is a five-pointscale that is more specifically related to socialfunctioning.

● The Global Symptom Index is measured using theSCL-90-R.

● The Symptom Checklist 90–Revised (SCL-90-R) is a90-item self-report inventory assessing currentlevels of mental symptoms patterns. Each itemis a description of a mental symptom rated on afive-point scale, and rates the degree of‘distress/discomfort’ during the week before itsadministration.

● The Ad hoc semi-structured interview for DSM-IIIcriteria for BPD is a semi-structured interviewbased on a 27-point scale made up of all theitems in each criterion category for BPD inDSM-III.

● The Health and Sickness Rating Scale (HSRS)includes a structured diagnostic interview,SCID-I and SCID-II, assessment ofemployment, social contact, suicide attemptsand treatment.

Results for behaviour (self-harm, alcohol and drug abuse), affect scales (BDI), therapy maintenance and hospitalisationoutcomesThe results for improvement in psychologicalsymptoms and interpersonal and socialfunctioning outcomes are presented inAppendix 3, (Tables 28 and 29). The results for theincluded studies are described below bycomparator.

RCTs Of the included nine RCTs seven were ofCBT: five of them were DBT,52–55,59 one was DBTorientated57 and one was MACT.58 Thecomparators were TAU,52–54,58,59 CVT+12S,55 andCCT.57 One study51 compared psychoanalyticallyorientated partial hospitalisation therapy withindividual therapy and one study56 comparedpsychodynamic structured IGP with individualtherapy (Table 2).

Cognitive behaviour therapy DBT versus TAU Of the four studies comparing DBT with TAU, three studies52–54

reported significantly greater improvement ofborderline symptoms such as parasuicide and/orsuicide attempts and drug abuse. However, onestudy59 did not find significant differences between DBT and TAU groups. This may haveoccurred because three studies52–54 were targetedto specific populations such as chronicparasuicidal or drug-abusing women, whereas thefourth study59 was a mixed group of parasuicidaland non-parasuicidal women with severe or lesssevere disorder. The study by van den Bosch andcolleagues59 was larger and conducted in Europe,in comparison with other smaller studies from theUSA. Thus, a different setting59 and a largersample size may have influenced the lessfavourable outcome. All trials reported thatmaintenance in the DBT group was greater thanin the TAU group. Koons and colleagues52

analysed the data of 20 (ten in each group) out of the original 28 randomised participants.Linehan and colleagues53 looked at the data on 44 (22 in each group) out of 63 randomisedpatients. In the second Linehan study,54 of 28 randomised participants seven in the DBTgroup and five in the TAU group were lost tofollow-up. Van den Bosch and colleagues59

reported that they lost almost 50% of the studyparticipants during the treatment period (in theDBT group ten out of 27 and in the TAU group24 out of 34). Three studies52–54 reported thatDBT patients received more therapy hours perweek. One study53 reported that control subjectshad significantly more psychiatric days per personhospitalised than patients who were receivingDBT. Two studies52,54 found no difference between DBT and TAU groups in terms ofhospital admission and one study59 did not report data on therapy contact and hospitaladmission. The details of these studies arepresented below.

Study: Linehan and colleagues (1991)53

Sample size: randomised n = 63; analysed ascompleters n = 44 (22 in each group); follow-upparasuicide assessment n = 39 (DBT n = 19,TAU n =20); all other follow-up assessmentsn = 20 (DBT n = 9, TAU n = 11).

Efficacy: the Linehan study53 looked at theparasuicide rate of chronically parasuicidalwomen, and found that the likelihood of anyparasuicide (DBT 63.6%, TAU 95.5%; p < 0.005)and medical risk scores (DBT mean 9.21, SD 8.22, n = 14; TAU mean 17.86, SD 20.94, n = 21; t = 1.70, df = 28.01, p < 0.05) were significantly higher for the TAU group. In thefollow-up year the suicide repeat rate (p < 0.01)


17


and the likelihood of psychiatric hospitalisation(p < 0.07) were lower in the participantscompleting DBT.

Maintenance in therapy: 83.3% and 42% of patientscompleted the entire treatment year in the DBTand TAU groups, respectively.

Therapy contact: DBT patients had more group(z = 5.51, p < 0.001) and individual (z = 2.00,p < 0.01) therapy hours per week, and the controlgroup reported more day treatment hours perweek (z=1.83, p < 0.05). No significantrelationship was found between the number ofindividual and group therapy hours andparasuicidal behaviour, independent of treatment.

Hospital admission: TAU participants tended tohave more hospital admissions per person (DBT median 0, interquartile range (IQR) 1; TAU median 1, IQR 4, z = 1.47, p < 0.07).Control subjects also had significantly morepsychiatric days per person hospitalised thanpatients who were receiving DBT. It is unclearwhether these hospital admissions were voluntaryor involuntary.


Sample size: n = 28 (DBT n = 12; TAU n = 16).

Efficacy: the second study by Linehan andcolleagues54 was conducted on borderline drug-dependent women and their primary outcome wasreduction of drug abuse. The proportion of drugabstinence was significantly higher for DBTparticipants during the 4–8-month period andduring the 12–16-month period (DBT mean 0.94,SD 0.17; TAU mean 0.58, SD 0.36, F = 4.04,p < 0.05). However, there were no between groupdifferences on other psychopathology outcomemeasures (e.g. parasuicide episodes, GSA, GAS oranger). At the 16-month follow-up DBTparticipants showed better social and globaladjustment, with significantly lower (better) scoreson the GSA (DBT mean 2.25, SD 0.75; TAU mean2.92, SD 0.71, F1,12 = 3.98, p < 0.05 for bestscores) and higher scores on the GAS (DBT mean69, SD 12; TAU mean 49, SD 10, F1,12 =22.24,p < 0.001 for best scores).

Maintenance in therapy: 64% in the DBT group and27% in the TAU group remained in treatment(Fisher’s exact test, p = 0.1). In DBT, a subject wasconsidered a dropout if 4 consecutive weeks ofscheduled individual sessions were missed for anyreason. In TAU, a subject was considered adropout from therapy if the participant either

never went to therapy or dropped out of therapyany time following a first session.

Therapy contact: DBT participants receivedsignificantly more psychological therapy (thehours are not reported) than did TAU participants(DBT mean 43.14, SD 10.67; TAU mean 21.88,SD 32.32; F1,15 = 2.07, p < 0.05). TAU wasanalysed by summing hours of psychotherapy andsessions spent with a case manager that wereprovided to TAU participants. This total was thencompared with DBT individual psychotherapysessions.

Hospital admission: no between-group differenceswere found in types and number of medical andinpatient psychiatric treatments received.

Study: Koons and colleagues (2001)52

Sample size: randomised n = 28 (DBT n = 13, TAUn = 15); analysed as completers n = 20 (10 ineach group).

Efficacy: Koons and colleagues52 found that theproportion of patients who reported anyintentional self-harm (including suicide attempt)during the previous 3 months dropped from 50%at pretreatment to 10% post-treatment in DBT,and from 30% to 20% in TAU (p = 0.07). Thedifferences between groups at pre-treatment arenot reported. Participants in DBT changedsignificantly more than did patients in TAU withregard to suicidal ideation (p = 0.008),hopelessness (p = 0.004), Beck Depression(p = 0.012) and Spielberg Anger Expression Scaleanger out (p = 0.005).

Maintenance in therapy: 20 out of 28 patientscompleted the treatment. Three patients in theTAU group dropped out either before treatmentor after the first appointment. Three participantsin the DBT group and two in the TAU group werelost to follow-up during the treatment period.

Therapy contact: DBT patients received more hoursof group therapy than did TAU patients (DBTmean 32.1, SD 9.6; TAU mean 11.8, SD 11.2; t18 = 4.35, p < 0.001), while the TAU participantsattended more hours of 30-minute medication-management visits (DBT mean 2.7, SD 2.2; TAU mean 7.6, SD 4.2; t18 = 3.27, p < 0.01).There were no differences in individual therapyhours.

Hospital admission: the proportion of patients withany admission during the prior 3 months wasrelatively low at pretreatment. Neither group

Effectiveness

18

showed a significant change in this proportion bythe end of treatment (DBT group had 30% ofpretreatment hospital admissions and 10% post-treatment admissions; TAU group had 20% ofpretreatment admissions, which reduced to 10%after the treatment).

Study: van den Bosch and colleagues (2002)59

Sample size: randomised n = 58 (DBT n = 27, TAUn = 31); analysed as completers and followed up:n = 34 (DBT n = 10, TAU n = 24).

Efficacy: van den Bosch and colleagues59 reportedthat the frequency and course of suicidalbehaviours were not significantly different acrosstreatment conditions: neither treatment condition(p = 0.866) nor the interaction between time andtreatment condition (p = 0.639) reached statisticalsignificance. Fewer patients in DBT (7%) than inthe control group (26%) attempted suicide. Thisdifference was not statistically significant(p = 0.064) A significant effect was observed forthe interaction term-time × treatment condition(p = 0.003), but not for treatment condition alone(p = 0.055). In terms of self-mutilating impulsivebehaviour, participants in the DBT groupsignificantly improved over time (interaction termtime × treatment condition), but not for treatmentcondition alone (p = 0.315).

Maintenance in therapy: significantly more patientsassigned to DBT (63%) were retained in therapythan patients in the control group (23%) for theentire treatment year (p = 0.002).

Therapy contact: not reported.

Hospital admission: not reported.

DBT versus CVT+12SOne study compared DBT with CVT+12S.


Sample size: n = 23 (DBT n = 11, CVT+12S n = 12).

Efficacy: Linehan and colleagues55 found thatparticipants in both treatment groups showedsignificant improvements. BSI (pretreatment mean1.78, SD 71; post-treatment mean 1.17, SD 0.60;z = 3.17, p < 0.002) and GAS (pretreatment mean37.6, SD 5.6; post-treatment mean 47.4, SD 10.7;z = 3.59, p < 0.001) scores were statisticallysignificant in both groups and maintained at12 months. At the 16-month follow-up point, BSIscores continued to improve but were not reliablydifferent from the 12-month point (mean 0.98, SD0.74, z = 1.76, p < 0.08) in both treatments. No

difference appeared between treatment groups onGSA rating. The parasuicidal behaviour duringthe treatment year was low (17.4% of patients), butdid not significantly differ by treatment.

Maintenance in therapy: there were three dropouts(36%). in the DBT group. There were no dropoutsin the CVT+12S group.

Therapy contact: there was no statistical differencein the mean number of individual sessionsreceived across the treatment year betweentreatments.

Hospital admission: the incidence of psychiatric anddrug-related visits to emergency rooms andinpatient units was low over the year, but notsignificantly different between groups.

DBT-orientated therapy versus CCTOne study compared DBT-orientated therapy withCCT.

Study: Turner (2000)57

Sample size: n = 24 (DBT-oriented therapy n = 12,TAU n = 12).

Efficacy: Turner57 found that suicide/self-harmbehaviour (rate of parasuicide, BSI, number ofsuicide and self-harm attempts) significantlyimproved in patients for both treatments(F6,84 = 26.8, p = 0.001, R2 = 0.657, repeatedmeasures multivariate analysis of variance).However, the DBT-orientated therapy patients’gains were greater than those receiving CCT atboth 6 months and 12 months (F6,84 = 5.1,p = 0.001, R2 = 0.268). In addition, the rating ofparasuicide [95% confidence interval (CI) 0.559 to2.83], the BSI (95% CI 3.1, 11.3) and the numberof suicide/self-harm attempts (95% CI 0.24 to 5.7)favoured DBT at 6 months and 12 months. Bothtreatments also improved patients’ emotionalfunctioning, but patients receiving DBT-orientatedtherapy had significantly lower scores than thosereceiving CCT on impulsiveness, anger anddepression at 12 months. Global mental healthfunctioning was also statistically significantlyimproved for both treatments (p = 0.005). Therewere no significant differences between two groupson anxiety.

Maintenance in therapy: 15 out of 24 patients were still in treatment at 12 months. Four DBTand six CCT participants withdrew fromtreatment. Of these patients one participant in the DBT group returned to DBT treatment after a5-week break.


19


Therapy contact: there were no significantdifferences between groups regarding the averagenumber of treatment sessions.

Hospital admission: number of days of psychiatrichospitalisation was not significant (p = 0.08).

MACT versus TAUOne study compared MACT with TAU.

Study: Tyrer and colleagues (2003)58

Sample size: randomised n = 480 (MACT n = 239,TAU n = 241). Participants with personalitydisorder n = 391, participants with BPD n = 67.

Efficacy: the Tyrer study,58 which was a large trial,found no significant improvement between thegroups in terms of parasuicide events. There wereno statistically significant treatment effects ofMACT according to centre (p = 0.48), baselineparasuicide risk score (p = 0.64) or personalitystatus (p = 0.66). The trial included participantswith different types of personality disorder and the severity and type of disorder influencedthe repetition of the self-harm. Many patients had more than one personality disorder; however, the authors managed to examine eachdisorder separately. Of the 67 borderline patients, 44.8% made no parasuicide attemptduring the follow-up. Of the 55.2% who had made at least one parasuicide attempt, the 25th percentile time to parasuicide event (in days) was 89 and the frequency of self-harm(rate per year) was 3.15. It was evident thatparticipants with personality disorder, especiallyBPD, had a greater incidence of repetition of self-harm, compared with participants without a personality disorder; however, therewere no differences between treatment conditions.

Maintenance in therapy: 40% of patients in MACTwere lost to follow-up during the treatment period.The results of the TAU group are not reported.

Therapy contact: in many cases the amount oftherapeutic time given in TAU exceeded that ofMACT considerably.

Hospital admission: there was no difference in theproportion of self-harm in the year afterrandomisation, between MACT and TAU.

Mentalisation-based partial hospitalisationMBT versus TAU One study compared MBT withTAU.

Study: Bateman and Fonagy (1999)51

Sample size: randomised n = 44 (n = 22 in eachgroup); analysed n = 38 (n = 19 in each group).

Efficacy: Bateman and Fonagy51 found a highly significant reduction in self-mutilatingbehaviour in the MBT group (Kendall’s W = 0.21,�2 =11.9, df = 3, p < 0.008) compared with theTAU group (Kendall’s W = 0.05, �2 = 2.4, df = 3,p = ns) and the number of participants who wereno longer parasuicidal was significantly greater by18 months in the MBT group than in the controlgroup (�2 = 7.0, df = 1, p < 0.08). Anxiety scoresdecreased significantly in the MBT group(p < 0.005) while remaining unchanged in theTAU group. Beck depression scores alsosignificantly decreased in the MBT group(p < 0.0001). The SAS score was significantlylower in the MBT group (mean = 2.8) than in theTAU group (mean = 3.3, p < 0.006).

Maintenance in therapy: there was a 12% dropoutrate in the MBT group. Three patients in the TAUgroup crossed over to the MBT group and werenot included in the analyses.

Therapy contact: patients in the control groupreceived considerably more staff time duringfollow-up than did patients in the MBT arm.

Hospital admission: no patient who completed theMBT programme was admitted to hospital within6 months after discharge. Within 1 year after theend of the trial one patient from the MBT groupand 14 patients from the TAU group had beenadmitted to hospital.

Psychodynamic therapyIGP versus individual therapy One study comparedIGP with individual therapy.

Study: Munroe-Blum and Marziali (1995)56

Sample size: randomised n = 79 (IGP n = 38,individual psychotherapy n = 41); analysed n = 48 (IGP n = 22, individual psychotherapyn = 26).

Efficacy: Munroe-Blum and Marziali56 reported nostatistically significant differences in outcomesbetween the two treatment groups. However, bothtreatment groups experienced significantimprovements over time on outcomes such asbehaviour, social adjustment, global symptoms anddepression from baseline.

Maintenance in therapy: 31 participants withdrewfrom the study at the point of randomisation.

Effectiveness

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Therapy contact: patient–therapist contact time wasconsiderably lower in the IGP group (90 hours)than in the individual group (120 hours).

Hospital admission: the use of mental health andsocial services decreased significantly by the end of12 months of follow-up (p < 0.038) for the totalcohort.

Non-RCT Appendix 3 (Table 29) presents theresults of improvements in psychological symptomsand interpersonal and social functioning. The trialreviewed in the current report56 was day hospitaltreatment (TAU) plus postdischarge groupanalytical therapy versus TAU.

Day hospital treatment (TAU) plus postdischarge group analytical therapy versus day hospital treatment (TAU)One non-RCT compared TAU plus postdischargegroup analytical therapy with TAU alone.

Study: Wilberg and colleagues (1998)60

Sample size: n = 43 (day treatment plus subsequentoutpatient group therapy n = 12, day treatmentonly group n = 31).

Efficacy: Wilberg and colleagues60 foundsignificantly (p < 0.05, two-tailed) higher (better)HSRS scores at discharge and follow-up for thetreatment group compared with the control group.They also found a significantly lower (better) GSIscore at follow-up for the treatment groupcompared with control (p < 0.05), although not atdischarge. Eight per cent (n = 1) of participants inthe treatment group attempted suicide comparedwith 18% (n = 5) in the control group (p = ns); 75%(n = 6) of the participants in the treatment groupshowed remission from substance use disordercompared with 41% (n = 7) in the control group.

Maintenance in therapy: two participants died, onefrom suicide and one from natural causes. Fourpatients refused to participate in the follow-up.The results were available from the data of 43patients (88%).

Therapy contact: between-group differences werenot reported.

Hospital admission: one participant (8%) in thetreatment group was rehospitalised, comparedwith 12 participants (43%) in the control group.The difference did not reach significance(p = 0.06, Fisher’s exact test, two-tailed).

Patient preference, satisfaction and acceptabilityInformation on patient preference, satisfactionand acceptability of treatment is presented inAppendix 3 (Tables 30 and 31).

RCTs One trial of DBT53 reported that treatmentsuccess did not improve general satisfaction,despite significant improvements in angerreduction and social adjustment.

One DBT study59 reported that all participantswho continued in therapy viewed the programmeas helpful and judged the treatment as veryimportant.

Non-RCT These aspects were not reported.

Quality of lifeOnly one study58 comparing MACT with TAUreported utilisation of a specific quality of life scale (EQ-5D). The EQ-5D scores were morefavourable at 6 and 12 months than at baseline(for both groups); however, they showed nodifferences between MACT and TAU (Table 7).

Summary of the assessment ofeffectivenessTable 8 presents a brief summary of the clinicaleffectiveness results. Ten studies were included inthis review, nine of which were RCTs and one wasa non-RCT. Active treatments included DBT, MBT, MACT and IGP. Comparators were TAU,CCT, CVT+12S, individual and day hospitaltherapies.

RCTs The results of the included studies aresummarised as follows. Three studies52–54

compared DBT with TAU and one study57

compared psychodynamically modified DBT with CCT. Three showed significant improvementsin the DBT group compared with the TAU and CCT groups. One study59 found improvement in both DBT and TAU groups;however, DBT was not more efficacious than theTAU group and both groups were equallyeffective.

Comparison of DBT with another activetreatment, CVT+12S,55 showed that both groupswere significantly effective; however, there were nodifferences between the two therapies.Comparison of MACT with TAU58 found MACTto be no more effective than TAU. One study51

found MBT to be more effective than TAU, andone study56 found IGP to be no more effectivethan individual therapy.

Non-RCT The study by Wilberg and colleagues60

found day hospital plus postdischarge groupanalytical therapy to be more effective than dayhospital on its own.


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TABLE 7 EuroQol scoresa at 6 and 12 months in MACT and TAU groups (by Tyrer et al., 2003)58

Baseline 6-month scores Difference (MACT – TAU)

n MACT (SD) TAU (SD) n MACT TAU Unadjusted (SE) Adjusted (SE)476 0.5 (0.3) 0.5 (0.3) 390 0.7 0.7 –0.01 (0.03) –0.01 (0.03)

Baseline 12-month scores Difference (MACT-TAU)

n MACT (SD) TAU (SD) n MACT TAU Unadjusted (SE) Adjusted (SE)476 0.5 (0.3) 0.5 (0.3) 400 0.7 0.7 0.00 (0.03) 0.00 (0.03)

a Higher scores represent better states

TABLE 8 Summary of clinical effectiveness

Study Study Study size Intervention Comparisons Evidence of clinical quality (total analysed) effectiveness for BPD

symptoms

RCTsBateman and Fonagy, Moderate to 38 MBT TAU Improvement in both groups, 199951 poor but MBT more effective than

TAU

Koons et al., 200152 Moderate 20 DBT TAU Improvement in both groups,but DBT more effective thanTAU

Linehan et al., 199153 Moderate to 44 DBT TAU Improvement in both groups, poor but DBT more effective than

TAU

Linehan et al., 199954 Moderate to 28 DBT TAU Improvement in both groups, poor but DBT more effective than

TAU

Linehan et al., 200255 Moderate to 23 DBT CVT+12S Improvement in both groups, poor but DBT group maintained

the efficacy longer thanCVT+12S

Munroe-Blum and Moderate to 48 IGP Individual Improvement in both groups, Marziali, 199556 poor psychotherapy but IGP no more effective

than individual psychotherapy

Turner, 200057 Moderate to 24 DBT- CCT Improvement in both groups, poor orientated but DBT more effective than

CCT

Tyrer et al., 200358 Moderate 480 MACT TAU Improvement in both groups, (PD n = 391, but MACT no more BPD n = 67) effective than TAU

van den Bosch et al., Moderate 34 DBT TAU Improvement in both groups, 200259 but DBT no more effective

than TAU

Non-RCTWilberg et al., 199860 Poor 43 Day hospital Day hospital Treatment plus TAU more

treatment (TAU) treatment effective than TAUplus postdischarge (TAU)

group analytical therapy

This chapter is in two parts. The first part is areview of the literature on the cost-

effectiveness of psychological therapies for BPD.The second part presents original cost-effectiveness analyses of the psychologicaltherapies based on data collected in the RCTsdescribed in the last chapter. The results arepresented in terms of cost per unit of effect, wherethe unit of effect is determined by the outcomesmeasured in the trials. The results are presentedas a series of incremental cost-effectivenessanalyses and the uncertainty is summarisedgraphically using cost-effectiveness acceptabilitycurves (CEACs).

Systematic review of existingeconomic literatureSearchStudies were identified using the search methodsreported in the section ‘Identification of studies’(p. 7) and Appendix 2.

Economic evaluations assessing the cost-effectiveness of any psychological therapy for BPDwere selected for inclusion. Studies were includedif both costs and benefits were reported and eithera cost-effectiveness ratio was reported or sufficientdetail was reported to enable a cost-effectivenessratio to be calculated. Studies where BPD subjectswere only partially represented were excludedunless a subgroup analysis was performed on theBPD subjects. The references retrieved by theeconomic searches (n = 1748) and the referencestagged as being RCTs from the clinicaleffectiveness searches (n = 1216) were assessed forinclusion in the review of cost-effectiveness. Aninitial title sift was carried out by one reviewer and2458 references were excluded. Two reviewers readabstracts of the remaining 506 references.Although some studies did contain relevantinformation, only one met the inclusion criteria asbeing suitable for review.68

One other study has been reviewed. The study byByford and colleagues69 was an economicevaluation alongside a clinical trial of MACT thatcollected costs and outcome data, but it wasconcerned with self-harming patients. Although

BPD patients were a subgroup in this study, fulleconomic evaluation was not undertaken for thissubgroup and so it should have been excludedfrom this review. However, an exception has beenmade for several reasons. First, it was the onlycost-effectiveness study identified that waspublished in a peer-reviewed journal. Secondly,the trial data from this study form an integral partof the cost-effectiveness analyses presented in thischapter. The study is therefore considered ofsufficient interest to be included in the review.

ReviewThe quality of the studies identified by the searchwas assessed using the British Medical Journalchecklist50 for economic evaluations (Appendix 6).

Cost-effectiveness studiesHeard (2000). Cost-effectiveness of dialecticalbehavior therapy in the treatment of borderlinepersonality disorder68

This dissertation by Heard presents the cost-effectiveness results of two psychotherapy outcometrials involving DBT. The first study is included inthe effectiveness review;53 however, the secondstudy is unpublished. In the first study subjectswere randomly assigned to receive 1 year of DBT(n = 22) or to receive TAU in the community(n = 22). Analyses suggested that at the end of1 year of treatment, subjects receiving DBT hadincurred significantly higher psychotherapy costs,lower psychiatric inpatient costs and loweremergency room costs compared with TAU. Thetwo groups did not differ significantly with respectto mean medical costs (DBT US$1161, 95% CI$589 to 1733; TAU $1799, 95% CI $710 to 2888)or total healthcare costs (DBT $9856, 95% CI$7292 to 12,420 (1988 prices); TAU $19,745, 95%CI $11,144 to 28,345). Analyses also revealedimportant differences in variance between the twoconditions, with the TAU arm having significantlygreater variance in terms of psychotherapy,inpatient, emergency room and total healthcarecosts. The two arms also did not differ in terms ofemployment or global functioning cost-effectiveness ratios.

In the second study the DBT subjects from thefirst study were compared with subjects whoseexisting therapists in the community had agreed to


23


Chapter 4

Cost-effectiveness

provide them with 1 year of stable psychotherapy(n = 16). At the end of 1 year of treatment,subjects receiving DBT had incurred significantlylower psychiatric inpatient costs and had a trendtowards better global functioning cost-effectivenessratios. The mean costs and cost-effectiveness ratiosdid not differ significantly between the two groupson any of the remaining variables. Finally, theTAU again had significantly greater variance interms of psychotherapy, inpatient and emergencyroom costs.

Comment This was a good-quality study thatscored highly on the BMJ checklist for economicevaluations. The cost-effectiveness analysis did notsupport the hypothesis that DBT is a more cost-effective treatment than TAU, though it sufferedfrom small numbers. Another shortcoming of thisstudy is the choice of economic outcome measures.Cost-effectiveness measured in terms of cost pernumber of weeks worked and cost per one-pointimprovement in global functioning is notcomparable to other disease areas and is of littleuse to decision-makers. A limitation of the study isthe lack of societal cost data and the cost ofconsultation that therapists receive for workingwith these patients. Societal costs are relevant forthis population and team consultation is stronglyemphasised in DBT. Excluding these costs mayhave given the DBT group an unfair advantage.

Byford and colleagues (2003). Cost-effectivenessof brief cognitive behaviour therapy versustreatment as usual in recurrent deliberate self-harm: a decision-making approach69

The Byford study is a cost-effectiveness analysis ofdata from an RCT [Prevention of Parasuicide byManual-Assisted Cognitive Behaviour Therapy(POPMACT)] comparing MACT with TAU for thetreatment of people with recurrent episodes ofDSH. The trial was conducted by Tyrer andcolleagues,58 in five centres in Glasgow,Edinburgh, Nottingham, West London and SouthLondon. The economic outcomes were cost per1% reduction in the proportion of patients with aself-harm episode and cost per quality-adjustedlife year (QALY) gained. The study took a broadsocietal perspective and included costs of hospital,community, voluntary and social services,community accommodation, the criminal justicesystem and productivity losses due to time takenoff work. The time horizon was the length of thetrial (12 months) and costs and benefits (self-harmepisodes and EQ-5D) were therefore notdiscounted. An interim cost analysis at 6 monthswas also conducted. Unit costs for hospital serviceswere based on local costs; all other unit costs were

based on national sources. The analysis wasperformed on an ITT basis. Mean costs in the twogroups were compared using standard t-tests withordinary least squares regression for adjustedanalysis. Bootstrapping techniques were used toconfirm the validity of the results.

Univariate sensitivity analysis was conducted byreplacing local unit costs with national ones,adjusting productivity costs, excluding communityaccommodation and including a mean cost forcourt appearances. Probabilistic sensitivity analysis(PSA) was conducted (based on repeated samplingusing bootstrapping techniques) and reported bymeans of CEACs.

Mean cost of treatment The overall mean cost perpatient was £13,450 and £14,288 (mean difference–£834, 95% CI –£2142 to 466) for the MACT andTAU groups, respectively. No statisticallysignificant differences between the groups werefound in the total costs or in the individualresource-use categories. No statistically significantcost difference was found between the MACT andTAU groups in any of the univariate sensitivityanalyses.

Cost-effectiveness analysis The cost per 1%reduction in the proportion of patients with arepeat self-harm episode was £120. However, theincremental mean effect as measured by the EQ-5D instrument, was negative for MACT(–0.01118). MACT was therefore cheaper but lesseffective than TAU using EQ-5D, although notsignificantly so. The incremental cost per QALYgained from TAU was £66,000, but this canpossibly be dismissed as a chance finding as theconfidence intervals for the mean difference incost are large.

PSA showed that the probability of cost-effectiveness of MACT compared with TAU usingthe percentage reduction in repeat self-harm wasover 90%, whatever the willingness to pay. UsingQALYs based on the EQ-5D, MACT was morecost-effective than TAU up to a willingness to payof £60,00 per QALY.

Comment This was a good-quality study thatscored highly on the BMJ checklist for economicevaluations. For the primary outcome measure ofcost per 1% reduction in the proportion ofpatients with a self-harm episode, MACT wascheaper and more effective than TAU. However,this unit of measurement is difficult to interpretsince it is a relative measure and so cannot becompared between studies. Furthermore, there are

Cost-effectiveness

24

questions about its appropriateness as the primaryoutcome for patients with BPD. Another limitationis that this outcome cannot be compared withother disease areas and so is not helpful todecision-makers.

The cost per QALY gained of £66,000 of TAU ishigher than is generally accepted by the NationalInstitute for Health and Clinical Excellence(NICE), but tells us little about the potential cost-effectiveness of MACT since it is based on a smalland non-significant difference in EQ-5D scores (–0.0118). This small difference, and one that wasin the opposite direction to the primary outcome,may have been the result of chance or the lack ofsensitivity of the EQ-5D to changes in this patientgroup.

An important limitation of this study, as far as thisreview is concerned, is that it covers far more thanBPD, since it includes people with recurrent self-harm and most of these people were notdiagnosed with BPD. In subgroup analysis of thesame trial data the authors report the cost of carefor patients with personality disorders.63 Inpatients with BPD, the average societal costs ofcare were higher for patients in the MACT group(£16,144) than in the TAU group (£14,185).Outcomes were not reported by treatment forBPD.

Studies assessing the cost of therapiesOnly two studies were identified that investigatedthe cost of therapy specifically for BPD patients.The Bateman study70 estimated the annualhealthcare utilisation costs for BPD patientsreceiving either partial hospitalisation or generalpsychiatric care. The setting was the Halliwick DayUnit at St Ann’s Hospital in the UK. Costs were reported in US dollars and have beenconverted back to pounds sterling using theexchange rate quoted in the publication. The year of unit costs is not stated. The mean (SD) cost of care at 18 months was £19,000 (£11,000) in the partial hospitalisation group and £22,000(£18,000) in the general psychiatric care group.

The Hall study71 compared the cost of 1 year ofpsychotherapy in 30 BPD patients with the cost ofthe previous year in which the same patientsreceived no formal psychotherapy. The mean costof care for 1 year of psychotherapy was AUS$ 7309(1998 unit costs). This includes the cost ofinpatient stay, outpatient visits, ambulatory care,diagnostics, medications and psychotherapytreatment.

Further details of these studies can be found inAppendix 7.

Cost-effectiveness and cost–utilityanalysisThe aim of this section is to assess the cost-effectiveness of different psychological therapies inthe treatment of BPD. This assessment of cost-effectiveness is not based on a conventionaldecision-analytic model owing to the complexnature of BPD and the lack of evidence. Theapproach has been to undertake a cost-effectiveness analysis for each of the nine RCTsreviewed in Chapter 3 using a combination of datareported in published papers, trial data sets sentby the investigators and a cost model using datafrom the POPMACT study. Cost-effectiveness hasbeen assessed in terms of cost per parasuicideevent avoided in six trials and cost per QALY hasalso been undertaken in four of the six studies (bymapping BDI results onto the EQ-5D in the caseof three trials; see Appendix 8).

Overall methodsModellingThe NICE guidelines for economic evaluation72

recommend undertaking a formal decision-analytic modelling approach. This was not felt tobe useful in BPD owing to the lack of evidence fora well-defined treatment pathway. The applicationof models to synthesise evidence was also inhibitedby the inability to conduct any meta-analysis of theclinical studies reviewed. As argued in the sectionon clinical effectiveness, the nine RCTs and onenon-RCT were too different in terms of theirpatient populations and interventions to permit aformal meta-analysis. For these reasons it wasdecided to undertake a series of economicevaluations on those trials that contain sufficientdata, namely six of the nine RCTs reviewed inChapter 3.51–53,57–59 The study-specific approachlimits the generalisability of the results and makescomparison between interventions difficult, but itdoes at least provide some evidence on thepotential cost-effectiveness of the interventions(where currently so little exists).

Technique of economic evaluationThe form of economic evaluation was limited bythe data collected in the clinical studies. For all sixRCTs, cost-effectiveness analyses are undertakenusing parasuicidal events as the unit of effect. Asdescribed later in some detail, this is a verylimited measure of outcome since it does notreflect the overall health-related quality of life of


25


the patient. The ideal approach would be toconduct cost–utility analysis, where the outcomesare expressed in the form of QALYs to permitcomparison with other health serviceinterventions. However, only one trial used apreference-based measure of health (POPMACT)and of the remainder, just three used outcomemeasures that could be mapped onto the EQ-5D.A cost-effectiveness analysis using events avoidedhas been undertaken in all six RCTs and acost–utility analysis in four out of the six.

Economic perspectiveThe NICE perspective is limited to the NHS andPersonal Social Service (PSS). However, the highconsumption by BPD patients of othergovernment services, such as the criminal justicesystem, makes a broader government perspectivemore relevant. The base case was therefore takenfrom a government perspective, with NICE andsocietal perspectives being presented in theunivariate sensitivity analyses.

Time horizonThe length of the follow-ups undertaken in thepublished studies limited the time horizon forthese analyses. Most studies were 12 months inlength and this has been applied in all studies.Studies of different durations have been convertedto 12 months by a simple pro-rata approach.

Outcome measureTo compare cost-effectiveness between studies, acommon outcome measure is required. Theoutcome measure most commonly reported acrossthe studies is the number of parasuicide events.The cost-effectiveness analysis by Byford andcolleagues,69 identified from the literature review,was based on the POPMACT study and used thismeasure. However, cost-effectiveness wasexpressed in terms of cost per 1% reduction in theproportion of patients with a self-harm episode.

There are several problems with this outcomemeasure. One is the use of a 1% reduction. This isproblematic because it is a relative measure andmay not mean the same between studies.Therefore, the absolute number of parasuicideevents was used as the main outcome measure,which provides a measure that is more meaningfulto decision-makers making comparisons acrossstudies. A more fundamental problem is the focuson just one outcome rather than a fuller measureof health-related quality of life, particularly sincethe relationship between the patient’s quality oflife and levels of parasuicide is not necessarily

linear. Parasuicide events are nonethelesscomprehensible to clinicians and decision-makersand although there is no willingness-to-pay figurefor this outcome, decision-makers may be able tocome to some judgement about a reasonablefigure.

The other problem with using parasuicide activityor related outcomes such as attempted self-harm isthat they have been defined in slightly differentways and may not be comparable between studies.We have attempted to standardise this wherepossible.

The QALY is used by NICE to undertakecomparisons across programmes and this wouldhave been a better measure to compare the cost-effectiveness of psychological therapies for BPD.In this appraisal, only the Tyrer study58 was foundto have used a preference-based measure of healththat could be used to generate QALYs. Analternative method is to use another self-reportmeasure of health and map that onto apreference-based measure. Three of the trials usedthe BDI, which has been previously mapped ontothe EQ-5D (Appendix B).73 This mappingfunction was applied to BDI data in three trials togenerate QALYs.

The BDI is typically reported at several trial time-points. To summarise these measurements andalso to take into account the between-groupdifferences at baseline, a mean QALY gain (orloss) has been calculated to be the area under thecurve (AUC).

CostsThe costs implications of the interventions aremore than the cost of the psychotherapy providedto patients in the experimental arm. BPD patientsare heavy users of resources across a large range ofservices69 and a successful therapy is likely to haveknock-on implications for the use of services wellbeyond the specific intervention being evaluatedin the trial. All resource consequences have beencosted. Costs were inflated to 2003/04 prices using the Hospital and community health servicespay and prices index (Office for NationalStatistics).74

Costs of psychological therapySessional costsThe costs of the interventions were estimated fromdescriptions provided in the published papers ofthe trials and other available documentation onthe number and type of sessions and the therapistsproviding the therapy.

Cost-effectiveness

26

The main concern with this approach is that theresources devoted to the interventions in the trials,particularly those undertaken in other countries,may not be typical of what would be provided inthe NHS. The dilemma is that in conducting aneconomic evaluation alongside a clinical trial, it isimportant to retain the internal validity from adirect link between the resources costed and thestudy outcomes since a different level of resourceis likely to have achieved a different outcome.However, the trial resource level may beunrealistic. The solution adopted here has been touse published trial data on the numbers ofsessions (individual and group), but to cost thesessions using UK estimates of the types oftherapist likely to be taking the sessions.

Estimates for the types of therapist conductingboth group and individual sessions are based on asurvey of DBT practitioners by the PsychologicalTherapies Research Centre at the University ofLeeds.75 All practitioners registered on the LeedsDBT Practice Research Network (PRN) databasewere sent a postal survey. The aim of the surveywas to address questions of how DBT wasimplemented, which clients and patients receivedDBT, and how services were being monitored andresearched. The percentage breakdown ofprofessionals delivering DBT was clinicalpsychologists (48%), nurses (26%), psychiatrists(8%) and occupational therapists (8%). Theremaining 10% were psychologists,psychotherapists, forensic psychologists or socialworkers (classed as ‘other therapists’ in Table 9).

Unless stated otherwise in the trial publications, itis assumed that two staff members76 deliver thegroup therapy to an average of seven or eightpatients (Rees A, Psychological Therapies ResearchCentre, University of Leeds: personalcommunication) and that sessions last on averagefor 2.25 hours.76 Individual therapy sessions areassumed to last for 1 hour,76 unless indicatedotherwise in the trial publications.

Staff time has been costed using national averagehourly costs for therapists taken from Curtis andNetten (2003),77 which include the fullemployment costs of the therapists, along withrelated costs such as general training (Table 9).The only exception to this is the cost of a clinicalpsychologist, which in Curtis and Netten is £69per hour of clinical contact. This seems to beunrealistically low and appears to be so because itdoes not include the costs of qualifications. Thecost of qualifications is considerable forprofessionals at this level; for example, the cost ofa consultant psychiatrist includes qualificationcosts of £26,000 per year. In the absence of analternative data source the cost of a psychologistwas based on expert opinion (Dent-Brown K,University of Sheffield: personal communication)and was estimated at half the cost of a consultantpsychiatrist.

TrainingThere is an extra cost associated with trainingpeople in the specific therapies evaluated in theRCTs. The cost of DBT training, for example, isbetween £1350 and £1925 per person dependingon the number of staff attending (British IslesDBT training. www.capricorn.uk.net). To includethis in the cost of DBT would require anassumption as to an annuity period and thenumber of patients treated in this period. The resulting annual mean cost per patient oftraining would be small and have little effect onthe overall results, and has therefore not beenincluded.

Telephone consultationAlthough DBT requires therapists to be availablefor telephone consultations, the only study thatreported telephone contact reported nostatistically significant difference between the DBTand TAU groups. Patients receiving TAU in theUK also have telephone contact with theirtherapist. The contrast is one of differentlystructured methods of delivering telephone


27


TABLE 9 Unit costs

Personnel and services National average unit cost Service

Consultant psychiatrist £272 Per 1-hour contactCommunity psychiatric nurse £72 Per 1-hour contactClinical psychologist £136 Per 1-hour contactSocial worker £99 Per 1-hour contactOccupational therapist £44 Per 1-hour contactOther therapists £118 Per 1-hour contactGP visit £85 Per 1-hour contactMental health services (inpatient) adult acute care £190 Per bed-dayA&E £83 Per first attendance

contact, rather than one of cost, and so the cost oftelephone contact has not been included in thisanalysis.

Staff supervisionDBT is a team effort, and an integral and essentialpart of the therapy is support for the therapistthrough regular supervision meetings with theother therapists. This constitutes a major costelement in the overall cost of DBT. Of the fourDBT studies, three52,59,78 report the frequency,number of hours and number of staff involved insupervision meetings, and this information hasbeen used to estimate a cost of supervision perpatient.

Staff delivering TAU may also receive supervision;however, no data were found to enable theresource implications to be quantified. To takeTAU staff supervision into account it was assumedthat TAU supervision is less resource-use intensiveby a factor of 0.5 compared with DBT supervision.This supervision cost has been added to all TAUarms. It was also assumed that there is nodifference in the supervision costs between thegroups in the non-DBT studies and the cost ofTAU supervision.

Other resource consequencesThe full range of additional resourceconsequences of BPD patients is shown in Table 10.

For three trials most of the resource-use data wereavailable from the published articles or theindividual-level data provided by theauthors.51,58,68 Resource-use data were convertedinto current UK prices using methods described inthe section below on study-specific methods. Intwo other studies,57,59 resource-use data were onlyavailable for length of inpatient hospital stay, andfor the remaining study52 no resource-use datawere available. It has been shown that inpatientlength of stay is the largest element of resourcecost79 and so the potential for modelling totalresource-use cost from inpatient hospital stay wasinvestigated. The relationship between thenumber of parasuicide events and resource-usecosts was also investigated to estimate a cost forthe study that did not have inpatient data.52

A key component in the costings was a cost modelrelating length of stay and parasuicide events tocosts. This required UK patient-level trial data andthe only trial data available that collected costs inall of the main resource categories (i.e. hospital,community health, social services, voluntary sector,community accommodation, criminal justice andproductivity), which can be combined to representthe perspectives of the government, NICE andsociety, was the Tyrer study.58

In the Tyrer study,58 no significant differences werefound between the MACT and TAU arms and it

Cost-effectiveness

28

TABLE 10 Resources used by BPD patients

Hospital Community Social services Voluntary Community Criminal Productivityservices health services sector accommodation justice

services system

Psychiatric Community Day centre/ Helpline Staffed Police officer Days off workinpatient psychiatry drop-in centre

psychology

Other Community Specialist Advice Unstaffed Prison/policeinpatient counselling education facility cell

A&E Community mental Sheltered Support Psychiatrichealth nurse/team workshop assessment

in custody

Psychiatric/ Community physical Social worker Counsellingpsychology therapyoutpatient

Other Primary care Home help Group therapyoutpatient

Day hospital Other community Other socialhealth services services

Medication

Source: Byford et al.69

was therefore considered appropriate to combineboth arms for the purposes of this investigation.The study had 480 self-harming patientsrandomised and with a reasonable proportionbeing BPD patients (n = 62). The cost modellingwas conducted on the BPD subgroup of patients.Since the Tyrer data also contain the cost oftherapy there may be an element of double-counting with the therapy costs. However, theaverage number of MACT sessions in the trial was so low (4.3) that double-counting of therapycost is expected to have a minimal impact onoverall cost.

A regression analysis was performed with inpatientlength of stay and parasuicide events as theindependent variables and total government cost asthe dependent variable. Both variables were foundto have significant coefficients. The analysis wasrepeated from the NHS and societal perspectives.The government perspective included all resourcesexcept for the voluntary sector services group,unstaffed community accommodation andproductivity cost. For the NICE perspective,hospital services, community health services, socialservices and the cost of staffed accommodation wereincluded. For the societal perspective all items wereincluded. From Table 11, it can be seen thatinpatient stay and parasuicide events account foraround two-thirds of the variation.

As reported above, the Koons study52 did notprovide data on inpatient stay. Therefore aregression model based on parasuicide eventsalone was used to estimate costs (Table 12). Theexplanatory ability of this model is poor(R2 = 0.1); however, in the absence of better datait gives some indication of the expected relativecosts of the treatment and control groups.

AnalysisThe cost-effectiveness results are presented in termsof incremental cost per parasuicide event avoidedand cost per QALY. PSA is used to investigate theimpact of the uncertainty around parameters. Itpermits an analysis of the effect of joint uncertaintyin all of the variables simultaneously. A distributionis attached to the range associated with each of thevariables in the analysis and Monte Carlosimulation simultaneously selects values from thespecified ranges and distributions. The simulationsare run 10,000 times to generate a distribution ofvalues. The results of this have been showngraphically on a cost-effectiveness plane for eachstudy.

The cost and effectiveness distributions for eachintervention are then combined to form a series ofnet benefit distributions, one for each interventionand at each level of willingness-to-pay. Finally, theprobability that the intervention of interest isoptimal is quantified and plotted for every valueof the willingness-to-pay threshold. PSA was usedto examine the probability that the intervention iscost-effective compared with the control arm atdifferent levels of willingness to pay for avoidingparasuicide events and per QALY. This has beenpresented graphically in the form of CEACs andin terms of the specific likelihood of anintervention being cost-effective compared withthe control arm at an arbitrary cut-off of £5000per suicidal event avoided and a cost per QALY of£20,000.

The PSA does not capture all of the uncertainty inthe results. One source of uncertainty is theperspective of the evaluation, which can includeNICE, government or societal. The impact of thisis explored in a univariate analysis. The other


29


TABLE 11 Results of the cost regression model based on parasuicide and length of stay (LOS)

R2 Coefficient SE

Government perspective 0.66(Constant) 3,767 818Parasuicide events 55 109Inpatient psychiatric LOS (days) 244 41

NICE perspective 0.76(Constant) 3,136 627Parasuicide events 18 84Inpatient psychiatric LOS (days) 256 32

Societal perspective 0.63(Constant) 13,414 643Parasuicide events 198 86Inpatient psychiatric LOS (days) 162 33

factors explored in the univariate analyses are therelative size of the supervision costs of TAU andthe costing of DBT.

Methods by studyThe methods used to analyse each study varydepending on the availability and source of dataand are therefore presented separately in thissection.

DBT trialsTurner (DBT versus CCT)57

This study attempted to keep the levels of therapyin DBT and CCT equal in terms of therapycontact hours and as a result no significantdifferences were reported between treatment armsin the number of therapy sessions. However, there was a cost difference between DBT and CCT sessions and so the mean number ofindividual therapy sessions for each arm wasneeded, but this was not reported. The numberwas estimated from the reported minimum (49)and maximum (84) number of therapy sessions.Six group therapy sessions were also provided foreach group.

Supervision costs were estimated from the numberof supervisors (two), the number of therapists(four) and the frequency of meetings (weekly intwo separate sessions). The length of the meetingswas not reported and was assumed to be 1 hour.Supervision costs were added to the CCT group bythe method described above.

Resource-use costs were estimated by applying theregression cost model to the number ofparasuicide events and the inpatient psychiatriclength of stay.

The definition of parasuicide is unclear in thisstudy. The authors state that “patients alsomaintained daily logs of suicide urges andattempts”, but the analysis assumed that it iscomparable to the other studies. The BDI wasreported at baseline, 6 months and 12 months,and these data were converted to the EQ-5Dpreference-based index using the mappingfunction and used to calculate QALYs using the AUC.

Linehan (DBT versus TAU)53

Costs were not provided in the published trialpaper for this study; however, costs are availablefrom a cost-effectiveness dissertation by Heard.68

The cost of therapy was reported separately forindividual therapy, group therapy and daytreatment. Resource-use costs were reported forpsychiatric inpatient stay, emergency room visits,physician visits and medical inpatient days. Thecosts reported in the Heard dissertation arereproduced in Table 13.

Heard reported unit costs alongside mean costsand so the mean hours of therapy and resourceuse could be estimated. These resource-use figureshave been recosted using current UK unit costs.Several assumptions are made in this costing: first, that sessional input will be delivered in theUK at the same level as in the Linehan study;secondly, that the efficacy rates will be similargiven the differences in service delivery in the UK compared with the Linehan study; andthirdly, that the amounts of psychiatric inpatientstay and other medical treatment are the same inthe UK as in the USA. Since the Linehan teampioneered DBT, it is reasonable to expect efficacyrates to be higher for them than for DBTdelivered in the UK. The first two assumptions,therefore, would probably result in a larger

Cost-effectiveness

30

TABLE 12 Cost regression model based on parasuicide events alone

R2 Coefficient SE

Government perspective 0.1(Constant) 4,518 1010Parasuicide events 320 124

NICE perspective 0.1(Constant) 3,924 891Parasuicide events 296 110

Societal perspective 0.22(Constant) 13,913 751Parasuicide events 374 92

difference in efficacy between treatments andcontrol than would be achieved in the UK and soexaggerate the difference. For the thirdassumption, inpatient stay is generally consideredto be used less in the USA than in the UK and theanalysis is likely to underestimate the cost savings.The overall impact of these differences isunknown.

Insufficient data were reported on supervisioncosts and therefore the average of the other threeDBT studies was used.

In the Linehan study,53 parasuicides weremeasured using the PHI. Although the BDI wasmeasured in this study, the values at 12 monthswere not reported and so QALYs could not beestimated.

Van den Bosch (DBT versus TAU)59

The annual mean hours of therapy for individualand group sessions were estimated from thenumber of patients in therapy, the proportioncontinuing therapy and the frequency of sessionsreported in the trial publication. In order toinclude the length of time that dropouts receivedtherapy, it is assumed that, on average, theywithdrew halfway through the trial.

Supervision costs were estimated based on thetypes of therapist delivering treatment and thefrequency of supervision meetings reported in thetrial publication. It was assumed that supervisionsessions last for 1 hour. Supervision costs wereadded to the TAU group by the methodsdescribed above.

No other resources were reported in the study, sothese were estimated by applying the regressioncost model to the number of parasuicide eventsand the inpatient psychiatric stay.

Parasuicide was measured with the LPCinstrument. The number of parasuicide events wascalculated from LPC trial data provided by theauthors. The BDI was not used in this study.

Koons (DBT versus TAU)52

The mean hours of individual therapy, grouptherapy and medication management visits werereported in the trial publication. These weremultiplied by the appropriate unit costs describedin the section ‘Costs’ (p. 26). Supervision costswere estimated for the types of therapistdelivering treatment and the frequency and lengthof supervision meetings reported in the trialpublication.

No other resource-use costs were reported, norwas length of stay. Other resource costs weretherefore estimated using the regression costmodel with number of parasuicide events as theonly independent variable. This is a very crudemodel and its estimates should be viewed withextreme caution.

Parasuicide was measured in this trial using thePHI, which is the same instrument used byLinehan’s group.53 The number of parasuicideattempts was reported at 3 and 6 months. For thepurposes of comparison with the other studies,these event rates were multiplied by a factor of 2to represent 12-month event rates. The BDI was


31


TABLE 13 Costs (1998 US$) reported by Heard80

DBT TAU

Treatment mode Unit cost Mean SE Mean SE

Outpatient psychotherapyIndividual hours $88 $3,885 $232 $2,915 $927Group hours $35 $1,514 $128 $147 $7Day treatment hours $77 $10 $10 $876 $167

Psychiatric inpatientDays $309 $2,612 $1,086 $12,079 $3,692

Emergency roomVisits $144 $226 $43 $569 $90

Medical treatmentPhysician visits $91 $783 $198 $650 $160Medical inpatient days $360 $360 $212 $1,096 $542

reported at baseline, 3 months and 6 months. Toestimate a QALY over 12 months, the assumptionwas made that the mean BDI scores remainconstant between months 6 and 12.

MBT trials(Bateman MBT versus TAU)51

This study was conducted over an 18-monthperiod. It was converted to a 12-month period prorata to make it comparable to the other studies.The 18-month study results are presented in thesensitivity analysis.

Therapy and other resource-use costs werereported in a cost analysis performed by theauthor. Other resource-use costs reported in thestudy were psychiatric inpatient and outpatientcare, medication and emergency room treatment.Social and other government costs were notincluded. Although twice-weekly supervision oftherapists was provided, the number of therapistsinvolved was not reported. The level ofsupervision appears comparable to DBT and theaverage supervision cost of DBT was thereforeassumed. Supervision costs were added to the TAU group by the method described above.Costs were reported in US dollars and wereconverted back to UK pounds using the exchangerate reported.

Suicide and self-harm acts were measured usingthe Suicide and Self-Harm Inventory. Thisinstrument is available from the trial authors andno further details were reported.

The number of suicide and self-harm events wascalculated from individual-level trial data suppliedby the authors. The BDI was reported at baselineand 3-month intervals thereafter. A mean QALYgain for both groups was estimated for 12 monthspro rata.

Tyrer (MACT versus TAU)58

The intervention therapy, other resource-use costs,parasuicide events and EQ-5D scores wereavailable from trial data supplied by the authors.69

From this data set the reviewers were able toundertake an analysis of the BPD subgroup. Thecost categories used to calculate costs from thegovernment, NICE and societal perspectives arethe same as those described above in theregression cost modelling. Supervision oftherapists was not described in the trialpublication. It was assumed that supervision forboth groups was similar to TAU. The cost of TAUsupervision (estimated by the method describedabove) was therefore added to both groups.

Parasuicide was measured using the PHI, the sameinstrument used by Linehan’s group.53 The EQ-5Dwas directly used in the study and this was used toestimate QALYs.

Cost-effectiveness resultsThe costs of the interventions and their studycontrol arms are shown in Table 14.

The mean therapy costs for DBT across the fourDBT trials were between £10,372 and £16,903 andin all cases exceeded the therapy costs in thecontrol arm, whether TAU or CCT. There was alower length of psychiatric inpatient stay and therewere fewer parasuicide events than in the controlarms. In two of the studies, the decrease ingovernment costs associated with the reduction inuse of services was sufficient to outweigh the costof the additional therapy53,57 and nearly tooutweigh the cost in another study.59 Only in thefourth study was there still a large incremental costfor the DBT arm.

For MBT and MACT, therapy costs were notrecorded separately. The mean total costs of theMBT patients (£18,174) were within the range ofthe DBT intervention groups, while the MACTpatients’ costs were somewhat lower (£9580). Thecosts of the control patients were roughly the samefor the MBT trial, but lower in the POPMACTstudy (£7563). The large cost difference betweenpatients in the POPMACT study and three of theother studies may be partly due to a degree ofdouble counting, since it was not possible toexclude therapy costs from the cost model (sincethe POPMACT data set did not separate theseout). However, overall those categories of costsmost likely to contain therapy, hospital psychiatricoutpatients and community NHS services,together only account for 23% of total cost.Therefore, double-counting does not account forthe order of difference between the three DBTstudies by Turner,57 Linehan53 and van denBosch59 compared with POPMACT. It also cannotaccount for any of the differences from theLinehan and Bateman studies,51,53 where actualother resource-use data collected in the trial wereused. The reason for the lower costs of MACTpatients is not clear.

Tables 15 and 16 present the key constituents ofthe cost-effectiveness analyses: total numbers ofparasuicidal events, total QALYs and total costsassociated with each arm of the trials, along withthe number of events avoided or QALYs gained

Cost-effectiveness

32

and the incremental costs. The incremental cost-effectiveness results are presented in three waysdepending on the results: where the interventionis both cheaper and more effective than thecontrol it is considered to dominate the controlarm; where the intervention is both moreexpensive and less effective than the control it is considered dominated by the control arm;and where the intervention costs more andis more effective the results are presented as anincremental cost per unit of benefit. The detailed results are now described by therapy and study in the same order as the Methodssection.

DBTTurner57

The incremental cost per patient of DBT overCCT was –£5242 and the incremental benefit was9.4 events avoided. At the mean level, DBT wasmore effective and cheaper than CCT and this is reflected in the plot on the cost-effective plane (Figure 2). The CEAC shows that DBT would have a probability of more than 80% ofbeing cheaper and more effective and theprobability that it would be preferable at athreshold of £5000 per event avoided was around85% (Figure 3).

The incremental QALY gain from DBT was 0.12and the domination of DBT is again reflected inthe cost-effectiveness plane (Figure 4). The CEACsuggests that DBT would have a probability of85% of being cheaper and more effective thanCCT and the probability that it would bepreferable at a threshold of £20,000 was around90% (Figure 5).

Linehan53

The incremental cost per patient of DBT overTAU was –£1207, with 26.7 events avoided.Although at the mean level DBT dominated TAU,there is rather more uncertainty surrounding thisresult than for the Turner study. The scatterplot

on the cost-effectiveness plane is clustered aroundall four quadrants (Figure 6). DBT had aprobability of around 53% of being cheaper andmore effective, and the probability that it would bepreferable at a threshold of £5000 was around60% (Figure 7).

van den Bosch59

The incremental cost per patient of DBT overTAU was £724 and the incremental number ofevents avoided 18.1. This results in an incrementalcost per event avoided of £724. The plot on thecost-effectiveness plane suggests a linearrelationship between events avoided and cost(Figure 8), which may reflect the fact that the costmodel used events avoided as one of theindependent variables. The CEAC is very flat,reflecting the uncertainty in this analysis; theprobability that DBT is cost-effective was around65% at all thresholds (Figure 9).

Koons52

The incremental cost per patient of DBT overCCT was £8625, with just 0.2 events avoided. Theincremental cost per event avoided was £43,124(Figure 10). The higher incremental cost may be aconsequence of using the simpler cost modelbased on events avoided, which did not take anyreduction in inpatient cost directly into account.However, the trial report indicates that there waslittle difference between the arms in hospitaladmissions. The probability of being cost-effectiveat £5000 per event avoided was below 40%(Figure 11).

The incremental QALY gain was 0.03 and thisresulted in an incremental cost per QALY of£273,801. This reflected the higher incrementalcost of DBT in this study. The cost-effectivenessplane reflects the high probability that DBT willcost more than TAU (Figure 12). The CEACsuggests that TAU would have a probability ofaround 95% of being the treatment of choice(Figure 13) at a willingness to pay of £20,000.


33


TABLE 14 Cost implications of psychological therapy

Intervention arm Control arm

Study Therapy costs Other costs Total Therapy costs Other costs Total

Turner (DBT vs CCT)57 £10,372 £5,371 £15,743 £9,428 £11,557 £20,985Linehan (DBT vs TAU)53 £13,033 £2,658 £15,691 £7,958 £8,941 £16,898van den Bosch (DBT vs TAU)59 £11,996 £5,434 £17,430 £6,060 £10,646 £16,706Koons (DBT vs TAU)52 £16,903 £6,536 £23,439 £8,206 £6,609 £14,815Bateman (MBT vs TAU)51 £18,174 £17,743Tyrer (MACT vs TAU)58 £9,580 £7,563

Cost-effectiveness

34 TA

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35


–120,000

–100,000

–80,000

–60,000

–40,000

–20,000

0

20,000

40,000

–5 0 5 10 15 20 25 30 35

Incremental PS events avoided

Incr

emen

tal c

ost (

£)

FIGURE 2 Turner: cost-effectiveness plane of parasuicide (PS) events avoided

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 10,000 20,000 30,000

Cost-effectiveness threshold (£)

Prob

abili

ty c

ost-

effe

ctiv

e

FIGURE 3 Turner: CEAC of PS events avoided

Cost-effectiveness

36

–120,000

–100,000

–80,000

–60,000

–40,000

–20,000

0

20,000

40,000

60,000

–0.05 0.00 0.05 0.10 0.15 0.20 0.25 0.30

Incremental QALYs

Incr

emen

tal c

ost (

£)

FIGURE 4 Turner: cost-effectiveness plane of QALYs

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 20,000 40,000 60,000 80,000 100,000


Prob

abili

ty c

ost-

effe

ctiv

e

FIGURE 5 Turner: CEAC of QALYs


37


–120,000

–100,000

–80,000

–60,000

–40,000

–20,000

0

20,000

40,000

–200 –100 0 100 200 300 400 500 600 700 800


Incr

emen

tal c

ost (

£)

FIGURE 6 Linehan: cost-effectiveness plane of PS events avoided

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 10,000 20,000 30,000


Prob

abili

ty c

ost-

effe

ctiv

e

FIGURE 7 Linehan: CEAC of PS events avoided

Cost-effectiveness

38

–400,000

–300,000

–200,000

–100,000

0

100,000

200,000

300,000

–250 –200 –150 –100 –50 0 50 100 150 200 250 300


Incr

emen

tal c

ost (

£)

FIGURE 8 van den Bosch: cost-effectiveness plane of PS events avoided

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 10,000 20,000 30,000Cost-effectiveness threshold (£)

Prob

abili

ty c

ost-

effe

ctiv

e

FIGURE 9 van den Bosch: CEAC of PS events avoided

MBTBateman51

In the baseline 12-month analysis, the centralestimate of the incremental cost per patient was£432 and number of events avoided was 11.3,resulting in a cost per event avoided of £38. Therewas a strong tendency for the intervention to bemore effective with little cost difference (Figure 14).At a threshold of £5000 there was an 80% chancethat the intervention would be cost-effective(Figure 15).

The cost per QALY was £7242. The cost-effectiveness plane demonstrates the uncertaintyin this analysis (Figure 16). This is also reflected inthe CEAC, which demonstrates that below athreshold of £20,000 there was a 55% chance thatTAU was more cost-effective than partialhospitalisation (Figure 17).

At 18 months 17 parasuicide events were avoided,at an incremental cost of £647, resulting in a costper event avoided of £38, as before, and littlereduction in uncertainty, with an 80% probabilitythat the intervention would be cost-effective at £5000 per event avoided (Figures 18 and 19).The cost per QALY was reduced from £7000 to£3000, but there was considerable uncertaintyaround the result (Figure 20). MBT had a

probability of around 40% to 50% of beingcheaper and more effective than TAU and theprobability that it was cost-effective at a threshold of £20,000 per QALY was around 55%(Figure 21).

MACTTyrer58

The central estimate for the incremental cost ofMACT over TAU was £2017 in BPD patients, with 3.2 more events. MACT was dominated by TAU in BPD. However, the uncertainty is such that the cost-effectiveness could range fromTAU dominating MACT to MACT dominatingTAU (Figure 22). The CEAC demonstrates thatthere was around a 60% chance that TAU would be more cost-effective than MACT (Figure 23).

The incremental QALY gain of MACT was 0.02and this resulted in a cost per QALY of £84,032.The direction of the gain in QALY contradicts theprimary outcome of parasuicide events (whichwere higher in the MACT group). However, therewas considerable uncertainty surrounding thisfigure and this is reflected in the plots on the cost-effectiveness plane (Figure 24). The probability ofbeing cost-effective at £20,000 was around 45%(Figure 25).


39


–100,000

–50,000

0

50,000

100,000

150,000

200,000

–80 –60 –40 –20 0 20 40 60


Incr

emen

tal c

ost (

£)

FIGURE 10 Koons: cost-effectiveness plane of PS events avoided

Cost-effectiveness

40

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0


Prob

abili

ty c

ost-

effe

ctiv

e

FIGURE 11 Koons: CEAC of PS events avoided

–100,000

–50,000

0

50,000

100,000

150,000

200,000

–0.15 –0.10 –0.05 0.00 0.05 0.10 0.15 0.20 0.25 0.30

Incremental QALYs

Incr

emen

tal c

ost (

£)

FIGURE 12 Koons: cost-effectiveness plane of QALYs


41


0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 20,000 40,000 60,000 80,000 100,000


Prob

abili

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ost-

effe

ctiv

e

FIGURE 13 Koons: CEAC of QALYs

–60,000

–50,000

–40,000

–30,000

–20,000

–10,000

0

10,000

20,000

30,000

40,000

–150 –100 –50 0 50 100 150 200


Incr

emen

tal c

ost (

£)

FIGURE 14 Bateman: cost-effectiveness plane of 12-month PS events avoided

Cost-effectiveness

42

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0


Prob

abili

ty c

ost-

effe

ctiv

e

FIGURE 15 Bateman: CEAC of 12-month PS events avoided

–50,000

–40,000

–30,000

–20,000

–10,000

0

10,000

20,000

30,000

40,000

–0.14 –0.12 –0.10 –0.08 –0.06 –0.04 –0.02 0.00 0.02 0.04 0.06 0.08

Incremental QALYs

Incr

emen

tal c

ost (

£)

FIGURE 16 Bateman: cost-effectiveness plane of 12-month QALYs


43


0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 20,000 40,000 60,000 80,000


Prob

abili

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ctiv

e

FIGURE 17 Bateman: CEAC of 12-month QALYs

–50,000

–40,000

–30,000

–20,000

–10,000

0

10,000

20,000

30,000

40,000

–150 –100 –50 0 50 100 150 200


Incr

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tal c

ost (

£)

FIGURE 18 Bateman: cost-effectiveness plane of 18-month PS events avoided

Cost-effectiveness

44

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0


Prob

abili

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ost-

effe

ctiv

e

FIGURE 19 Bateman: CEAC of 18-month PS events avoided

–50,000

–40,000

–30,000

–20,000

–10,000

0

10,000

20,000

30,000

40,000

–0.30 –0.20 –0.10 0.00 0.10 0.20 0.30 0.40

Incremental QALYs

Incr

emen

tal c

ost (

£)

FIGURE 20 Bateman: cost-effectiveness plane of 18-month QALYs


45


0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0


Prob

abili

ty c

ost-

effe

ctiv

e

0 20,000 40,000 60,000 80,000 100,000

FIGURE 21 Bateman: CEAC of 18-month QALYs

–80,000

–60,000

–40,000

–20,000

0

20,000

40,000

60,000

80,000

–100 –80 –60 –40 –20 0 20 40


Incr

emen

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ost (

£)

FIGURE 22 Tyrer: cost-effectiveness plane of PS events avoided

Cost-effectiveness

46

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0


Prob

abili

ty c

ost-

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ctiv

e

FIGURE 23 Tyrer: CEAC of PS events avoided

–80,000

–60,000

–40,000

–20,000

0

20,000

40,000

60,000

80,000

100,000

0 0.02 0.04 0.06 0.08 0.10 0.12 0.14

Incremental QALYs

Incr

emen

tal c

ost (

£)

FIGURE 24 Tyrer: cost-effectiveness plane of QALYs

Univariate sensitivity analysisNICE economic perspectiveFor those studies where the costing for otherresources was based on the regression model, theNICE perspective did not alter the direction ormagnitude of the cost-effectiveness results. Thismay be due to the fact the regression coefficientsin the government and NICE models had asimilar order of magnitude. The direction andmagnitude of the Tyrer results58 were also similarwhen costs were estimated from the trial data froma NICE perspective.

Societal perspectiveThe societal model has the effect of increasing themagnitude of costs in both arms by a factor ofapproximately 75%. The van den Bosch study59

was the only one in which the societal model

resulted in a change in the direction of the results.Using the societal model the incremental cost inthis study became –£818, and the interventiondominated TAU.

Supervisor costsIn the baseline analysis TAU supervision costswere assumed to be less than DBT supervisioncosts by a factor of 0.5. This factor was increasedto 0.75 (increasing control arm costs) anddecreased to 0.25 (decreasing control arm costs).For the Bateman (MBT) and van den Bosch (DBT)studies,51,59 a factor of 0.75 resulted in theintervention arm becoming cheaper than thecontrol arm and therefore DBT dominated TAU.A factor of 0.25 resulted in small increases in thecost per QALY or events avoided for van denBosch59 and Koons,52 and a three- to four-foldincrease for Bateman.51


47


0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0


Prob

abili

ty c

ost-

effe

ctiv

e

0 20,000 40,000 60,000 80,000 100,000

FIGURE 25 Tyrer: CEAC of QALYs

Main results: clinical effectivenessNine RCTs and one non-RCT of moderate to poorquality were identified in the clinical effectivenessreview. Of these ten studies, six show that there issome evidence that psychological therapies forBPD may be effective, whereas the evidence fromfour trials suggests that psychological therapies areno more effective than the alternatives. However,these results should be interpreted with caution asnot all studies were primarily targeted toborderline symptoms and there were considerabledifferences in patient characteristics, comparisongroups and outcomes between the studies.

Main results: cost-effectivenessThe review of published studies identified onecost-effectiveness analysis of data from an RCTcomparing DBT with TAU for the treatment ofBPD. Subjects were women who were clinicallyreferred to a psychotherapy outcome study.Subjects receiving DBT (n = 22) incurredsignificantly higher psychotherapy costs, lowerpsychiatric inpatient costs and lower emergencyroom costs than those receiving TAU (n = 22).The two treatment groups did not differsignificantly with respect to median medical ortotal healthcare costs. The cost-effectivenessmeasures used were cost per week employed andcost per point of global adjustment and nosignificant difference was found in either of thesemeasures for DBT compared with TAU.

The review of published studies also identified aneconomic evaluation of psychological therapies ofpartial relevance to BPD. This was a cost-effectiveness analysis of data from an RCTcomparing MACT with TAU for the treatment ofpeople with recurrent episodes of DSH. There wereno significant differences between the groups inthe total costs across all patients or among thosewith BPD (n = 62). The cost per 1% reduction inthe proportion of patients with a repeat self-harmepisode was £120, with more than 90% chance ofbeing cost-effective, but this analysis was notundertaken for the BPD subgroup. Theincremental mean effect as measured by the EQ-5D instrument was negative for MACT (–0.01118).

The incremental cost per QALY gained from TAUwas therefore £66,000, but the authors argued thatthis was probably a chance finding given that thedifference in EQ-5D was not significant.

A formal decision modelling approach could notbe applied given the complex care pathways forpatients with BPD and the lack of evidence. It wasdecided instead to undertake separate economicevaluations for the six RCTs that had sufficientdata using a combination of data reported inpublished papers, trial data sets sent by theinvestigators, a cost model using data from thePOPMACT study and a utility mapping exercise.Cost-effectiveness was assessed in terms of cost perparasuicide event avoided in all six trials and costper QALY in four of them (this was done bymapping BDI results onto the EQ-5D for threetrials). All results are at 2003/04 prices and for12 months follow-up.

In three of the four DBT trials the interventiondominated the control groups in terms ofparasuicide events (Turner57 and Linehan53) orachieved a cost per event avoided below £50 (vanden Bosch59). However, in a fourth DBT trial theestimated cost per event avoided was £43,124.While the studies by Linehan53 and van denBosch59 seem favourable to DBT in terms of meanincremental cost-effectiveness, the probability ofbeing cost-effective at £5000 per parasuicide eventavoided was around just 60% in each case. Onlytwo DBT trials were subjected to a cost per QALYanalysis, and for one the intervention againdominated (Turner57) and the other had a cost perQALY of £273,801. The PSA showed substantialuncertainty surrounding these results. ForKoons,52 the probability of DBT being cost-effective was very low (at less than 10%). Thismixture of results, high levels of uncertainty andthe limitations described in the next section donot support the cost-effectiveness of DBT,although they suggest that DBT could potentiallybe cost-effective.

The MBT study group achieved a very low costper event avoided, with a probability of being cost-effective at £5000 per parasuicide eventavoided of 80%. While the cost per QALY wasmodest at £7242, there was substantial uncertainty,


49


Chapter 5

Discussion

with a probability of being cost-effective at £20,000per QALY of less than 60%. For POPMACT, theBPD subgroup analysis undertaken by theassessment team found that the intervention wasdominated in terms of cost per parasuicide eventavoided. There was an insignificant incrementalQALY gain in BPD, but the associated cost perQALY was £84,032. These assessments of MACTwere both associated with a high degree ofuncertainty, where the probability of being cost-effective was less than 50% in each case.

Assumptions, limitations anduncertaintiesClinical effectivenessThe size of the studies was small. Therefore, a lackof power was a major problem for the majority oftrials. Bias was likely in some trials owing to a lackof blind outcome assessment, unclear allocationconcealment and high dropout rates. Most trialsincluded only women or predominantly women,limiting their generalisability.

A significant number of BPD patients usually donot complete the programme; thus, greatertherapist involvement is necessary.53 The degree oftherapist involvement in most intervention groupswas high. Therapists in experimental groups tendto have a more effective and supportive approach,with flexible relationships with patients, thantherapists in control groups, which may have led tothe lower attrition rates in the intervention arms.

The level of training and supervision of thetherapist as well as therapist beliefs may haveinfluenced the treatment outcomes. The therapistswith special training, previous experience and aparticular interest in working with patients withBPD may have achieved more success in thetreatment than would be achieved in a routinesetting. For example, the trials by Linehan’s groupwere conducted in research clinics, whichspecialised in these patients. Personnel madeconsiderable efforts to keep patients in treatment,which is not usual in normal practice. Althoughthe principle of BPD therapies is based ondeveloping a strong working alliance betweentherapist and client to prevent withdrawal andconsequently to provide a complete treatmentcourse, this requires considerable skills, effort andtime from therapists and may not be a practicalapproach for busy mental health settings.

One trial52 compared two active psychologicaltreatment conditions where the same

pharmacotherapy was administered in bothgroups. Although both groups significantlyimproved at the end of the treatment, there wereno differences between the two treatments and theauthors assumed that the effect might haveoccurred because of the drug. Therefore, it isimportant to consider drug administration instudies examining psychosocial therapies.

The long-term efficacy of psychological therapiesis unclear, since the longest reported follow-up was36 months,51 at which time significant reductionsin clinical symptoms of the intervention arm notonly were maintained but continued to declineand were associated with low hospital admissionrates.

DBT was one of the more successful treatments,with significant positive outcomes in relation toreducing self-harm and improving behaviouralcontrol in women. However, most studies comefrom a single group of investigators whodeveloped the method and have a strongallegiance to it. More recent and moreindependent replication of these trials with alarger sample in Europe found that DBT is notsignificantly more effective than TAU.

There was insufficient evidence to examinewhether any particular type of psychologicaltreatment is more effective than others.

Most of the BPD participants in trials werereferred by tertiary care settings and described as“(severely) parasuicidal” or “substance abusing”,which omitted the rest of the (less severe, non-parasuicidal or non-substance-abusing) BPDpatients. Such patients cannot fully represent theBPD population.

The need for a common scale for major clinicaloutcomes derives from the considerableheterogeneity of measures for assessing similarvariables. Also, there is a need for more generichealth-related quality of life measures.

Little information has been provided in thestudies regarding patient preference. Research isstill needed in these areas.

Finally, the authors are confident that they havenot missed any important RCTs; however, thereview of the non-RCTs might not have beensufficiently thorough. The reason for thisuncertainty is that BPD can be included as asubgroup in general personality disorder,parasuicide/self-harm, suicide attempts, A&E and

Discussion

50

forensic studies. These would require a largenumber of studies to be reviewed and would havebeen beyond the resources available for thisreview.

Cost-effectivenessThe two studies that provided a cost-effectivenessanalysis were of good quality, but the Heardstudy68 had limitations concerning the lack ofimportant cost data and the Byford study69 wasconcerned with DSH and not just BPD. Apublished subgroup analysis did not replicate thefull economic analysis. Indirectly, however, theByford study provided important evidence on thelikely cost-effectiveness of MACT, which was usedin a subgroup analysis undertaken by thisassessment team, and the trial provided data forthe economic analyses undertaken for the otherRCTs presented in this report.

The assessments of cost-effectiveness undertakenfor each of the six trials presented in this reportmust be interpreted with great care. The trialswere conducted in different settings in patientswith varying baseline disease conditions. Inaddition, the methods and types of staff used todeliver the therapy differed, as did the length,frequency and type of sessions delivered. Thesedifferences make comparisons between the trialsproblematic. The comparability of TAU betweenthe trials is also questionable. For two of thestudies, the analysis only uses parasuicide eventsavoided, which limits the generalisability of theresults and makes comparison betweeninterventions difficult. Comparison betweenstudies even using this outcome is limited becausethe studies used different definitions of theoutcome measure.

The methods for assessing outcome used in theeconomic analysis are also subject to limitations.The cost-effectiveness analysis used the number ofparasuicide events avoided and, as reportedearlier, there was some variation between studies in the recording of these events.Furthermore, this is not an outcome that capturesall of the consequences of the interventions for patients and is not a useful outcome fordecision-makers concerned with allocatingresource across programmes. This reviewattempted to estimate QALYs to try to capture a more patient-focused outcome that provides amore generic assessment of benefit. However, only one study directly measured QALYs and for three others a mapping from the BDI to theEQ-5D that was, inevitably, not completelyaccurate.

There are more general concerns with the use ofQALYs in this condition and specifically QALYsthat use the EQ-5D preference-based measure.The EQ-5D may not capture all of theconsequences for health-related quality of life ofpeople with BPD. There have been no validationstudies of EQ-5D in BPD. Suggestions for furtherwork in this area are suggested below.

The methodology to estimate costs differs betweenthe trials. Some trials reported costs in detail,whereas others had to be estimated using simpleregression models. The estimation of resource usefor the Koons study52 is particularly weak, since itwas based on a poor association betweenparasuicide events and total costs. However, thenumber of parasuicide events was similar for botharms in this trial and the use of this modelprobably had little influence on the cost-effectiveness results.

The cost-effectiveness estimates are also dependenton the quality of the trials, which were small andsuffered from high dropout rates. This wouldsuggest that in many cases the results exaggeratethe cost-effectiveness of the interventions. Theremust also be doubts about the generalisability ofthe results from these trials. Most of the DBTstudies, for example, were undertaken in countriesoutside the UK and there must be doubts as towhether the results are transferable to the NHS.These results merely indicate the potential cost-effectiveness of DBT and MBT.

Need for further researchResearch into psychological interventions for BPDhas tended to comprise either uncontrolled studieswhere it is impossible to interpret the findings, orsmall, poor-quality RCTs with high rates ofdropouts that have not been properly followed up.At the same time, little thought has been given tothe needs of contemporary economic analysis,although there are some notable exceptions. Theresults have produced a body of evidence that hasbeen largely inconclusive. BPD is an importantcondition with a number of resource-intensivetherapies available and it should be a priority areafor future research. Here, more detailedsuggestions are made for further research in termsof pragmatic trials and studies to inform economicevaluation.

Pragmatic controlled trialsThe basic evidence of clinical efficacy was poor.Appropriately powered, head-to-head RCTs of


51


psychological therapies are needed. The keyfeatures of these trials include the following:

● Where possible, a trial should have more thanone psychological therapy being compared.

● Studies must be designed with adequate statisticalpower, taking into account expected dropouts.

● Patients from a variety of ethnic and socio-economic backgrounds must be included, withan age and gender mix comparable to thosereceiving treatment in the NHS.

● The level of severity and dysfunction must bewell defined in future surveys and trials.

● The definition of dropout must be standardisedand reduced where possible in the RCTsexamining psychological therapies for BPD.Where patients drop out of therapyconsiderable effort must still be undertaken tocollect data on them.

● The different therapies need to be properlydescribed, including a TAU arm. Medication,for example, must be taken into account.

● Studies comparing active intervention with TAUneed to be designed so that TAU is indeed thatand not minimal intervention to maximise thebenefits associated with interventionpsychological therapies.

● The longest follow-up was for 18 months, and 6months was more common. Given the high costof the interventions, longer term follow-upsshould be undertaken.

● Data should be collected on outcomes,including recognised generic measures ofhealth-related quality of life, as well aspreference-based measures to permitcomparisons across programmes (see below).

● Data should be collected on resource-useservices (see below).

● Research teams should include independentresearchers.

Studies to inform future economicanalysisThe lack of data and complexity of the carepathway of BPD meant that a conventional

economic model that synthesised a range ofevidence could not be constructed for this report.This makes it difficult to conduct an estimate ofthe value of information to provide evidence onthe size of investment needed and the prioritiesfor future research. However, based on theanalyses presented here the authors are able torecommend the following (in addition to theabove on clinical effectiveness).

● Conducting cost-effectiveness analyses was inpart limited by the complexity of the condition,but also the absence of good data on currentpractice. Survey work is needed into currentpractice in terms of pathways of care to begin to be able to model the longer term benefitsusing a more formal decision modellingapproach.

● A survey of current practice and the use of thefull range of services (including number ofsessions attended and type of therapist) bypeople with BPD is needed to inform futureeconomic analyses.

● Full resource-use data must be collected in thecontext of pragmatic clinical trials.

● A psychometric assessment is needed of thevalidity of the EQ-5D and other genericpreference-based measures in BPD.

● If the generic measures are found wanting, thena more condition-specific preference-basedmeasure must be developed that captures theimpact of BPD on people’s lives.

Related to the above researchrecommendationsIt must be recognised that BPD is not ahomogeneous condition and it often occursalongside other psychological co-morbidities.

Research is needed to determine the relationshipof BPD and co-occurring major disorders todevelop an optimal multicomponent programme, which will be targeted not only toBPD-specific symptoms but also to the coexisting problems.

Discussion

52

There is some evidence to support the clinicaleffectiveness of psychological therapies for

BPD.

● There is some evidence that DBT is moreeffective than TAU for the treatment ofchronically parasuicidal and drug-dependentwomen with BPD.

● There is some evidence that DBT-orientatedtherapy is more effective than CCT for thetreatment of BPD.

● There is some evidence that DBT is as effectiveas CVT+12S for the treatment of opioid-dependent women with BDP.

● There is some evidence that MBT is moreeffective than TAU in the treatment of BPD.

● There is good evidence that MACT is no moreeffective than TAU in the treatment of BPD.

● There is some evidence that IGP is no moreeffective than individual MBT for the treatmentof BPD.

● There is some evidence that TFP is moreeffective than TAU.

The overall efficacy of psychological therapies ispromising; however, at this stage the evidence isinconclusive.

In terms of cost-effectiveness, this reviewattempted to examine the cost-effectiveness of theintervention in six RCTs. The mix of resultsbetween the four trials of DBT, along with thehigh levels of uncertainty and the limitations ofthe analyses, do not support the cost-effectivenessof DBT, although they suggest that it has thepotential to be cost-effective. The results for MBTare promising, although again surrounded by ahigh degree of uncertainty, and for MACT theanalysis suggests that the intervention is unlikelyto be cost-effective.

Although the results do not support the cost-effectiveness of any psychological interventionover the rest, or of psychological therapy as awhole, the results do offer the hope that suchinterventions could be cost-effective. What isneeded now are well-designed, pragmatic RCTs ofthe leading therapies in head-to-headcomparisons with appropriate patient-focusedoutcomes (including an appropriate preference-based measure) and resource-use data collection,with formal modelling of the longer termconsequences.


53


Chapter 6

Conclusions

The authors wish to thank Dr Ian Kerr(Consultant Psychiatrist, Sheffield), Professor

Kate Davidson (Consultant Clinical Psychologist,Glasgow), Dr Graham Connell-Jones (ConsultantForensic Psychiatrist, Nottingham), Professor PeterTyrer (Professor of Community Psychiatry,London) and Dr Nick Huband (Department ofForensic Mental Health, Nottingham) for acting asclinical advisors to the project. Also many thanksto Sarah Byford, Peter Tyrer and Marco Chiesa forproviding additional useful trial data. The authorsalso wish to thank Gill Rooney and AndreaShippam for their help in preparing andformatting the report.

Contribution of authorsIndra Tumur (Research Fellow) and MichaelFerriter (Research Fellow) compiled the clinicaleffectiveness section. John Brazier (Professor ofHealth Economics) and Michael Holmes (ResearchAnalyst) wrote the economic evaluation section.Glenys Parry (Professor of Applied PsychologicalTherapies) and Kim Dent-Brown (PostdoctoralResearch Fellow) provided the backgroundinformation and Suzy Paisley (Research Scientist)did the literature searching.


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91. Bohus M, Haaf B, Stiglmayr C, Pohl U, Bohme R,Linehan M. Evaluation of inpatient dialectical-behavioral therapy for borderline personalitydisorder – a prospective study. Behav Res Ther2000;38:875–87.

92. Bohus M, Haaf B, Simms T, Limberger MF,Schmahl C, Unckel C, et al. Effectiveness ofinpatient dialectical behavioral therapy forborderline personality disorder: a controlled trial.Behav Res Ther 2004;42:487–99.

93. Brobyn S, Goren S, Lego S. The borderlinepatient: systemic versus psychoanalytic approach.Arch Psychiatr Nurs 1987;1:172–82.

94. Battegay R, Klaui C. Analytically oriented grouppsychotherapy with borderline patients as long-term crisis management. Crisis: Journal of CrisisIntervention and Suicide 1986;7:94–110.

95. Buzov I, Persic-Brida M. Rascjepljivanje iprojektivna identifikacija u kratkoj dinamskojpsihoterapiji granicnog poremecaja licnosti[Splitting and projective identification in shortdynamic psychotherapy of patients with aborderline personality disorder]. SocijalnaPsihijatrija 1985;13:21–30.

96. Chiesa M, Drahorad C, Longo S. Earlytermination of treatment in personality disordertreated in a psychotherapy hospital: quantitativeand qualitative study. Br J Psychiatry2000;177:107–11.

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98. Clarkin JF, Hull J, Yeomans F, Kakuma T, Cantor J.Antisocial traits as modifiers of treatment responsein borderline inpatients. Journal of PsychotherapyPractice and Research 1994;3:307–12.

99. Damman G, Kachele H. Outcomes ofpsychodynamic treatment of borderline disorders.Nervenheilkunde 2001;20:31–7.

100. Dolan B, Warren F, Norton K. Change inborderline symptoms one year after therapeuticcommunity treatment for severe personalitydisorder. Br J Psychiatry 1997;171:274–9.

101. Hirvas J. [Practical experience with psychoanalyticmanagement of borderline personality disorder][in Finnish]. Duodecim 1987;103:1387–90.

102. Karterud S, Kvarstein E, Pedersen G. Severelydisturbed borderline patients need more thanshort-term day hospital treatment. TherapeuticCommunities 2004;25:120–30.

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61


This appendix contains information on thesources and keyword strategies used in the

identification of studies.

Electronic databases searchedAddiction Abstracts

ASSIA (Applied Social Sciences Index andAbstracts)

CareData

CDSR (Cochrane Database of Systematic Reviews)

CENTRAL (Cochrane Central Register ofControlled Trials)

Diss Abs (Dissertation Abstracts)

EconLIT

EMBASE

IBSS (International Bibliography of the SocialSciences)

Index to Theses

ISIP (Institute for Science InformationProceedings)

MEDLINE

NHS DARE (NHS Database of Abstract of Reviewsof Effectiveness)

NHS EED (NHS Economic Evaluation Database)

HTA (Health Technology Assessment Database)

NCJRSA (National Criminal Justice ReferenceService Abstracts)

OHE HEED (Office of Health Economics HealthEconomic Evaluations Database)

PsycINFO

PUBMED

Soc Abs (Sociological Abstracts)

SSA (Social Services Abstracts)

UKOP (United Kingdom Official Publications)

WOS (Web of Science)

Sources consulted via the WorldWide WebAHRQ (Agency for Healthcare Research andQuality)

AIHW (Australian Institute of Health and Welfare)

AHFMR (Alberta Heritage Foundation for MedicalResearch)

APA (American Psychiatric Association)

APA (American Psychological Association)

Bandolier

BPD Research Foundation

BIGSPD (British and Irish Group for the Study ofPersonality Disorders)

Campbell Collaboration

CCOHTA (Canadian Co-ordinating Office forHealth Technology Assessment)

CCT (Controlled Clinical Trials)

CEMH (Centre for the Economics of MentalHealth)

CenterWatch

CHE (Centre for Health Economics)

Chestnut Lodge Hospital

CRD (Centre for Reviews and Dissemination)

DoH PRP (Department of Health Policy ResearchProgramme)

DACEHTA (Danish Centre for Evaluation andHealth Technology Assessment)

DPHE (Department of Public Health andEpidemiology, University of Birmingham)

DTB (Drug and Therapeutics Bulletin)

Harvard CEA Registry (Harvard Cost EffectivenessAnalysis Registry)

HCNA (Health Care Needs Assessmentepidemiological reviews)

HEBE (Health Boards Executive)

HERC (Health Economics Research Centre)


63


Appendix 1

Identification of studies

HERG (Health Economics Research Group)

HERU (Health Economics Research Unit)

Home Office

HSPSCB (High Security Psychiatric ServicesCommissioning Board)

HSRU (Health Services Research Unit)

ICSI (Institute for Clinical Services Improvement)

INAHTA Clearing House (International Networkof Associations for Health Technology Assessment)

Institute of Psychiatry

ISSPD (International Society for the Study ofPersonality Disorders)

MIHSR (Monash Institute for Health ServicesResearch)

MIND (National Association for Mental Health)

mRCT (Meta Registers of RCTs)

MSAC (Medical Services Advisory Committee)

NGC (National Guideline Clearinghouse)

NPC (National Prescribing Centre)

NCCHTA (National Co-ordinating Centre forHealth Technology Assessment)

NHS QIS (NHS Quality Improvement, Scotland)

NHS R&D Programmes (including forensic mentalhealth)

NHSC (National Horizon Scanning Centre)

NIH (National Institutes of Health)

NIH Clinical Trials Database

NIMHE (National Institute for Mental Health inEngland)

North of England Guidelines

NSF Mental Health (National Service Frameworkfor Mental Health)

NZHTA (New Zealand Health TechnologyAssessment)

PDI (Personality Disorders Institute)

PSSRU, Kent (Personal and Social ServicesResearch Unit)

RAND Corporation

RCP (Royal College of Physicians)

RCPsych (Royal College of Psychiatrists)

SBU (Swedish Health Technology Assessment)

SIGN (Scottish Intercollegiate Guidelines)

SPR (Society for Psychotherapy Research)

Thames Valley Initiative

Therapeutics Initiative (Vancouver)

WPA (World Psychiatric Association)

Appendix 1

64

All searches were undertaken in March 2005.

Addiction Abstracts1996 onwardsMetaPress version

Personality disorder or personality disorders orborderline

ASSIA1987 onwardsVia Cambridge Scientific Abstracts (CSA)

Clinical effectiveness searchLast Search Query: ((((DE="Borderline personalitydisorder") or (DE="Personality disorders") or(otherwise specified) or (axis ii) or(behavi*ral dyscontrol) or bpc or (cluster b) or(borderline and(personality or disorder*)) or (severe personalitydysfunction) or(unstable personality) or ((dissocial or dramatic oremotional* orerratic or flamboyant or impulsivity or instability)within 3(personality or disorder*))) and((DE=("Psychotherapy" or "Analyticalpsychotherapy" or "Child analyticalpsychotherapy" or "Art therapy" or"Behaviour therapy" or "Aversion therapy" or"Cognitive behaviourtherapy" or "Covert sensitization" or"Selfreevaluation therapy" or"Stress inoculation training" or "Verbal satiation" or"Contingencycontracts" or "Habit reversal" or "Implosivetherapy" or "Interruptionprompting" or "Stimulus control" or "Subconsciousretraining" or"Behavioural psychotherapy" or "Cognitivebehavioural psychotherapy" or"Bibliotherapy" or "Brief therapy" or "Solutionsbased brief therapy" or"Child psychotherapy" or "Posttraumatic childtherapy" or

"Psychoanalytic child psychotherapy" or "Cognitivepsychotherapy" or"Countertransference"or "Couple therapy" or "Systemic couple therapy"or "Dialogicalpsychotherapy" or "Drama therapy" or "Duotherapy" or "Existentialpsychotherapy" or "Experiential psychotherapy" or"Experimentalpsychotherapy" or "Family therapy" or "Behaviourfamily therapy" or"Brief family therapy" or "Cognitive behaviourfamily therapy" or"Contextual therapy" or "Developmental familytherapy" or "Family playtherapy" or "Medical family therapy" or "Multiplefamily therapy groups"or "Structural family therapy" or "Systemic familytherapy" or "Feministtherapy" or "Forensic psychotherapy" or "Gestalttherapy" or "Grouppsychotherapy" or "Analytical grouppsychotherapy" or "Sociotherapygroups" or "Forensic group psychotherapy" or"Psychodynamic grouppsychotherapy" or "Individual psychotherapy" or"Interpersonalpsychotherapy" or "Milieu therapy" or "Mother-Infant psychotherapy" or"Multimodal therapy" or "Music therapy" or"Primal therapy" or"Psychoanalytic supportive psychotherapy" or"Psychodrama" or"Psychodynamic therapy" or "Brief psychodynamictherapy" or"Psychosynthesis" or "Psychotherapeutictechniques" or "Mirroring" or"Rational-Emotive therapy" or "Reality therapy" or"Social economytherapy" or "Supportive psychotherapy" or"Therapeutic communities" or"Transactional analysis" or "Transference" or "Self-Object transference"or "Validation therapy")) or(DE=("Psychotherapeutic techniques" or"Mirroring")) or (DE=("Psychotherapists" or"Analyticalpsychotherapists"or "Child psychotherapists" or "Grouppsychotherapists" or "Analytical


65


Appendix 2

Database keyword strategies

group psychotherapists")) or (DE="Psychologicalservices") or(DE="Psychological intervention") or(DE=("Psychoanalysis" or"Castrationanxiety" or "Psychological splitting" or "Seductiontheory" or"Selfobjects" or "Selfpsychology")) or(DE=("Psychoanalysts" or "Socialwork psychoanalysts")) or (DE=("Group therapy"or "Brief group therapy"or "Cognitive group therapy" or "Feminist grouptherapy" or "Group focalconflict theory" or "Psychoanalytic group therapy"or "Psychoeducationalgroup therapy" or "Sensitivity training" or"Crosscultural sensitivitytraining")) or psychotherap* or boscot or cat orcbt or dbt or(democratic within 2 communit*) or (therapeuticcommunit*) or (hendersonhospital*) or psychoanaly* or psycho-analy* orpsycho-therap* or ipt ormact or popmact or linehan or stepps or (crisisintervention) or((therap* or treatment* or strateg* or approach*or system* orintervention* or program* or oriented or focus*or framework) within 2(analytic or autogenic or behavi*r* or bio-cognitive or biocognitive orbrief or dynamic* or cognitive or client cent*redor outpatient orindividual or validation or day patient ordialectic* or eclectic orexpressive or family or inpatient or insight orintensive orinterpersonal or interpretive or long term orlongterm or intermittentormanuali?ed or mentali?ation or partialhospitali?ation or psychodynamic*or psycho-dynamic* or supportive or talk* or timelimited or short termor transference or framework orpsychoeducational or psychological orpsychosocial)))))

Cost-effectiveness searchLast Search Query: ((DE="Borderline personalitydisorder") or(DE="Personality disorders") or (otherwisespecified) or (axis ii) or(behavi*ral dyscontrol) or bpc or (cluster b) or(borderline and(personality or disorder*)) or (severe personalitydysfunction) or

(unstable personality) or ((dissocial or dramatic oremotional* orerratic or flamboyant or impulsivity or instability)within 3(personality or disorder*))) and ((cost* oreconomic* or qaly*) or(quality adjusted))

CareData1993 onwardsElectronic Library for Social Care

Borderline in tiBorderline in abPersonality disorder not borderline in tiPersonality disorder not borderline in ab

Cochrane Library (CDSR andCENTRAL)Issue 1, 2005Wiley version

Borderline in All Fields and personality in All Fields

Dissertation Abstracts1861 onwardsProQuest

Borderline personality and (therapy or treatmentor psychotherapy)Borderline personality and (cost* or economic* orqaly* or quality adjusted)

EconLIT1969 onwardsSilverPlatter WebSPIRS Version 4.3

#1 borderline and (personality or disorder*)

EMBASE1980 onwardsSilverPlatter WebSPIRS Version 4.3

Clinical effectiveness search#44 #18 and #43#43 #19 or #20 or #21 or #22 or #23 or #24 or#25 or #26 or #27 or #28 or #29 or #30 or #31or #32 or #33 or #34 or #35 or #36 or #37 or#38 or #39 or #42#42 #40 near2 #41

Appendix 2

66

#41 analytic or autogenic or behavio?r* or bio-cognitive or biocognitive or brief or dynamic* orcognitive or client cent?red or outpatient orindividual or validation or day patient or dialectic*or eclectic or expressive or family or inpatient orinsight or intensive or interpersonal or interpretiveor long term or longterm or intermittent ormanuali?ed or mentali?ation or partialhospitali?ation or psychodynamic* or psycho-dynamic* or supportive or talk* or time limited orshort term or transference or framework orpsychoeducational or psychological or psychosocial#40 therap* or treatment* or strateg* orapproach* or system* or intervention* orprogram* or oriented or focus* or framework#39 crisis intervention*#38 counsel*#37 stepps#36 popmact#35 linehan#34 mact#33 ipt#32 psychoanaly* or psycho-analy*#31 henderson hospital*#30 therapeutic communit*#29 democratic near2 communit*#28 dbt#27 cbt#26 cat#25 boscot#24 psychotherap* or psycho-therap*#23 'counseling-' / all subheadings inDEM,DER,DRM,DRR#22 explode 'psychodynamics-' / all subheadingsin DEM,DER,DRM,DRR#21 'psychological-and-psychiatric-procedures-techniques-and-concepts' / all subheadings inDEM,DER,DRM,DRR#20 'psychoanalysis-' / all subheadings inDEM,DER,DRM,DRR#19 explode 'psychotherapy-' / all subheadings inDEM,DER,DRM,DRR#18 #1 or #2 or #3 or #4 or #5 or #6 or #7 or#8 or #9 or #10 or #11 or #12 or #13 or #14or #15 or #16 or #17#17 instability near3 (personality or disorder*)#16 impulsivity near3 (personality or disorder*)#15 flamboyant near3 (personality or disorder*)#14 erratic near3 (personality or disorder*)#13 emotional* near3 (personality or disorder*)#12 dramatic near3 (personality or disorder*)#11 dissocial near3 (personality or disorder*)#10 unstable personality#9 severe personality dysfunction#8 borderline and (personality or disorder*)#7 cluster b#6 bpc

#5 behavio?ral dyscontrol#4 axis ii#3 otherwise specified #2 'personality-disorder' / all subheadings inDEM,DER,DRM,DRR#1 'borderline-state' / all subheadings inDEM,DER,DRM,DRR

Cost-effectiveness search#20 #18 and #19#19 explode 'economic-aspect' / all subheadings inDEM,DER,DRM,DRR#18 #1 or #2 or #3 or #4 or #5 or #6 or #7 or#8 or #9 or #10 or #11 or #12 or #13 or #14or #15 or #16 or #17#17 instability near3 (personality or disorder*)#16 impulsivity near3 (personality or disorder*)#15 flamboyant near3 (personality or disorder*)#14 erratic near3 (personality or disorder*)#13 emotional* near3 (personality or disorder*)#12 dramatic near3 (personality or disorder*)#11 dissocial near3 (personality or disorder*)#10 unstable personality#9 severe personality dysfunction#8 borderline and (personality or disorder*)#7 cluster b#6 bpc#5 behavio?ral dyscontrol#4 axis ii#3 otherwise specified #2 'personality-disorder' / all subheadings inDEM,DER,DRM,DRR#1 'borderline-state' / all subheadings in DEM,D

IBSS1951 onwardsVia BIDS (Bath Information and Data Services)

Clinical effectiveness search((Borderline and (personality or disorder*)) orpersonality disorder*) and (treatment* or therap*or psychotherapy*)

Cost-effectiveness search((Borderline and (personality or disorder*)) orpersonality disorder*) and (cost* or economic* orqaly* or quality adjusted)

Index to Theses1716 onwardsExpert Information

(borderline and (personality or disorder*)) or(personality disorder*)


67


ISIP1990 onwardsWeb of Knowledge

Clinical effectiveness search#1 TS=borderline and TS=(personality or

disorder*)#2 TS=(otherwise specified or axis ii or

behavio*ral dyscontrol or bpc or borderlinestate or cluster b or severe personalitydysfunction or unstable personality orpersonality disorder*)

#3 TS=(dissocial* or dramatic or emotional* orerratic or flamboyant or impulsivity orinstability) same TS=(personality or disorder*)

#4 #1 or #2 or #3#5 TS=(psychotherap* or psycho-therap* or

psychoanaly* or psycho-analy* or counsel*ingor boscot or cat or cbt or democraticcommunit* or therapeutic communit* orhenderson hospital* or ipt or mact or linehanor popmact or stepps or crisis intervention)

#6 TS=(therap* or treatment*) sameTS=(analytic or autogenic or behavio*r* orbio-cognitive or biocognitive or brief ordynamic* or cognitive or client cent*red orindividual or validation or dialectic* or eclecticor expressive or family or group or insight orintensive or interpersonal or interpretive orlong term or longterm or intermittent ormanuali?ed or mentali?ation or partialhospitali?ation or psychodynamic* or psycho-dynamic* or supportive or talk* or timelimited or short term or transference orframework or psychoeducational orpsychological or psychosocial)

#7 #5 or #6#8 #4 and #7

Cost-effectiveness search#1 TS=borderline and TS=(personality or




#4 #1 or #2 or #3#5 TS=(cost* or economic* or qaly* or quality

adjusted)#6 #4 and #5

MEDLINE1966 onwardsOvid Online version 9.3

Clinical effectiveness search1 Borderline Personality Disorder/2 Personality Disorders/3 otherwise specified.tw.4 axis ii.tw.5 behavio?ral dyscontrol.tw.6 BPC.tw.7 cluster b.tw.8 (borderline and (personality or disorder$)).tw.9 severe personality dysfunction.tw.

10 unstable personality.tw.11 (dissocial adj3 (personality or disorder$)).tw.12 (dramatic adj3 (personality or disorder$)).tw.13 (emotional$ adj3 personality disorder$).tw.14 (erratic adj3 (personality or disorder$)).tw.15 (flamboyant adj3 (personality or disorder$)).tw.16 (impulsivity adj3 (personality or disorder$)).tw.17 (instability adj3 (personality or disorder$)).tw.18 or/1-1719 exp Psychotherapy/20 Psychoanalysis/21 exp Psychological Techniques/22 Counseling/23 (psychotherap$ or psycho-therap$).tw.24 boscot.tw.25 cat.tw.26 cbt.tw.27 dbt.tw.28 (democratic adj2 communit$).tw.29 therapeutic communit$.tw.30 henderson hospital$.tw.31 (psychoanaly$ or psycho-analy$).tw.32 ipt.tw.33 mact.tw.34 linehan.tw.35 popmact.tw.36 stepps.tw.37 counsel$.tw.38 crisis intervention.tw.39 (therap$ or treatment$ or strateg$ or

approach$ or system$ or intervention$ orprogram$ or oriented or focus$ orframework).tw.

40 (analytic or autogenic or behavio?r$ or bio-cognitive or biocognitive or brief or dynamic$or cognitive or client cent?red or outpatient orindividual or validation or day patient ordialectic$ or eclectic or expressive or family orinpatient or insight or intensive orinterpersonal or interpretive or long term orlongterm or intermittent or manuali?ed ormentali?ation or partial hospitali?ation or

Appendix 2

68

psychodynamic$ or psycho-dynamic$ orsupportive or talk$ or time limited or shortterm or transference or framework orpsychoeducational or psychological orpsychosocial).tw.

41 ((therap$ or treatment$ or strateg$ orapproach$ or system$ or intervention$ orprogram$ or oriented or focus$ or framework)adj2 (analytic or autogenic or behavio?r$ or bio-cognitive or biocognitive or brief or dynamic$ orcognitive or client cent?red or outpatient orindividual or validation or day patient ordialectic$ or eclectic or expressive or family orinpatient or insight or intensive or interpersonalor interpretive or long term or longterm orintermittent or manuali?ed or mentali?ation orpartial hospitali?ation or psychodynamic$ orpsycho-dynamic$ or supportive or talk$ or timelimited or short term or transference orframework or psychoeducational orpsychological or psychosocial)).tw.

42 or/19-38,4143 18 and 42

Cost-effectiveness search1 Borderline Personality Disorder/2 Personality Disorders/3 otherwise specified.tw.4 axis ii.tw.5 behavio?ral dyscontrol.tw.6 BPC.tw.7 cluster b.tw.8 (borderline and (personality or disorder$)).tw.9 severe personality dysfunction.tw.

10 unstable personality.tw.11 (dissocial adj3 (personality or disorder$)).tw.12 (dramatic adj3 (personality or disorder$)).tw.13 (emotional$ adj3 personality disorder$).tw.14 (erratic adj3 (personality or disorder$)).tw.15 (flamboyant adj3 (personality or disorder$)).tw.16 (impulsivity adj3 (personality or disorder$)).tw.17 (instability adj3 (personality or disorder$)).tw.18 or/1-1719 Economics/20 exp "Costs and cost analysis"/21 Economic value of life/22 exp Economics, hospital/23 exp Economics, medical/24 Economics, nursing/25 exp models, economic/26 Economics, pharmaceutical/27 exp "Fees and charges"/28 exp Budgets/29 ec.fs.30 (cost or costs or costed or costly or costing$).tw.31 (economic$ or pharmacoeconomic$ or price$

or pricing).tw.

32 Quality-adjusted life years/33 (qaly or qalys).af.34 (quality adjusted life year or quality adjusted

life years).af.35 or/19-3436 18 and 35

NCJRSA1975 onwardsVia CSA

Clinical effectiveness search(((personality disorder*) or (borderline and(personality ordisorder*))) and (treatment* or therap* orpsychotherap*))

Cost-effectiveness search((personality disorder*) or (borderline and(personality ordisorder*))) and ((cost* or economic* or qaly*) or(quality adjusted))

NHS DARE, NHS EED, HTADate coverage not known (approx. 1994–2005)CRD website version

Borderline and personality

OHE HEEDDate coverage not knownCD-ROM version

Borderline or personality

PsycINFO1887 onwardsSilverPlatter WebSPIRS Version 4.3

Clinical effectiveness search#44 #19 and #43#43 #20 or #21 or #22 or #23 or #24 or #25 or#26 or #27 or #28 or #29 or #30 or #31 or #32or #33 or #34 or #35 or #36 or #37 or #38 or#39 or #42#42 #40 near2 #41#41 analytic or autogenic or behavio?r* or bio-cognitive or biocognitive or brief or dynamic* orcognitive or client cent?red or outpatient or


69


individual or validation or day patient ordialectic* or eclectic or expressive or family orinpatient or insight or intensive or interpersonalor interpretive or long term or longterm orintermittent or manuali?ed or mentali?ation orpartial hospitali?ation or psychodynamic* orpsycho-dynamic* or supportive or talk* or timelimited or short term or transference orframework or psychoeducational or psychologicalor psychosocial#40 therap* or treatment* or strateg* orapproach* or system* or intervention* orprogram* or oriented or focus* or framework#39 crisis intervention*#38 counsel*#37 stepps#36 popmact#35 linehan#34 mact#33 ipt#32 psychoanaly* or psycho-analy*#31 henderson hospital*#30 therapeutic communit*#29 democratic near2 communit*#28 dbt#27 cbt#26 cat#25 boscot#24 psychotherap* or psycho-therap*#23 explode 'Psychotherapeutic-Processes' inMJ,MN#22 explode 'Psychotherapeutic-Techniques' inMJ,MN#21 'Cognitive-Therapy' in MJ,MN#20 explode 'Psychotherapy-' in MJ,MN#19 #1 or #2 or #3 or #4 or #5 or #6 or #7 or#8 or #9 or #10 or #11 or #12 or #13 or #14or #15 or #16 or #17 or #18#18 instability near3 (personality or disorder*)#17 impulsivity near3 (personality or disorder*)#16 flamboyant near3 (personality or disorder*)#15 erratic near3 (personality or disorder*)#14 emotional* near3 (personality or disorder*)#13 dramatic near3 (personality or disorder*)#12 dissocial near3 (personality or disorder*)#11 unstable personality#10 severe personality dysfunction#9 borderline and (personality or disorder*)#8 cluster b#7 bpc#6 behavio?ral dyscontrol#5 axis ii#4 otherwise specified#3 'Personality-Disorders' in MJ,MN#2 'Borderline-States' in MJ,MN#1 'Borderline-Personality' in MJ,MN

Cost-effectiveness search#19 and #20#20 cost* or economic* or qaly* or qualityadjusted#19 #1 or #2 or #3 or #4 or #5 or #6 or #7 or#8 or #9 or #10 or #11 or #12 or #13 or #14or #15 or #16 or #17 or #18#18 instability near3 (personality or disorder*)#17 impulsivity near3 (personality or disorder*)#16 flamboyant near3 (personality or disorder*)#15 erratic near3 (personality or disorder*)#14 emotional* near3 (personality or disorder*)#13 dramatic near3 (personality or disorder*)#12 dissocial near3 (personality or disorder*)#11 unstable personality#10 severe personality dysfunction#9 borderline and (personality or disorder*)#8 cluster b#7 bpc#6 behavio?ral dyscontrol#5 axis ii#4 otherwise specified#3 'Personality-Disorders' in MJ,MN#2 'Borderline-States' in MJ,MN#1 'Borderline-Personality' in MJ,MN

PUBMEDSeptember 2004 onwardsVersion not known

Clinical effectiveness search#5 Search #3 and #4 Limits: 180 Days#4 Search treatment* or therap* or

psychotherap* or psycho-therap*#3 Search #1 or #2#2 Search personality disorder*#1 Search borderline and (personality or

disorder*)

Cost-effectiveness search#5 Search #3 and #5 Limits: 180 Days#4 Search cost* or economic* or qaly* or quality

adjusted#3 Search #1 or #2#2 Search personality disorder*#1 Search borderline and (personality or

disorder*)

SSA1980 onwardsVia CSA

Appendix 2

70



Soc Abs1963 onwardsVia CSA



UKOP1980 onwardsThe Stationery Office

Borderline or personality

WOS1981 onwardsWOK

Clinical effectiveness search

#1 TS=borderline and TS=(personality ordisorder*)

#2 TS=(otherwise specified or axis ii orbehavio*ral dyscontrol or bpc or borderlinestate or cluster b or severe personalitydysfunction or unstable personality orpersonality disorder*)


#4 #1 or #2 or #3#5 TS=(psychotherap* or psycho-therap* or

psychoanaly* or psycho-analy* or counsel*ingor boscot or cat or cbt or democraticcommunit* or therapeutic communit* orhenderson hospital* or ipt or mact or linehanor popmact or stepps or crisis intervention)

#6 TS=(therap* or treatment*) sameTS=(analytic or autogenic or behavio*r* orbio-cognitive or biocognitive or brief ordynamic* or cognitive or client cent*red orindividual or validation or dialectic* or eclecticor expressive or family or group or insight orintensive or interpersonal or interpretive orlong term or longterm or intermittent ormanuali?ed or mentali?ation or partialhospitali?ation or psychodynamic* or psycho-dynamic* or supportive or talk* or timelimited or short term or transference orframework or psychoeducational orpsychological or psychosocial)

#7 #5 or #6#8 #4 and #7

Cost-effectiveness search#1 TS=borderline and TS=(personality or




#4 #1 or #2 or #3#5 TS=(cost* or economic* or qaly* or quality

adjusted)#6 #4 and #5


71



73


Appendix 3

Evidence tables for BPD studies

This appendix contains the evidence tables with data extracted from the 10 studies included in thisreview.

TABLE 17 Studies included in the review

Study Funding, location Intervention Study type Patient population

Bateman and NR, UK Partial hospitalisation RCT Patients with severe Fonagy, 199951 (MBT) parasuicidal BPD

Koons et al., VA Research Advisory Group grant, DBT RCT Women Veterans with 200152 USA BPD

Linehan et al., Grant MH34486, National Institute of DBT RCT Chronically parasuicidal 199153 Mental Health, Bethesda, USA women with BPD

Linehan et al., Grant DA08674, National Institute of DBT RCT Substance-abusing 199954 Drug Abuse, Bethesda, USA women with BPD

Linehan et al., Grant DA 08674, National Institute of DBT RCT Heroin-dependent 200255 Drug Abuse, National Institute of women with BPD

Health, USA

Munroe-Blum Ontario Mental Health Foundation; Time-limited IGP RCT Patients with BPDand Marziali, Grant 88-87-89, grants 6606-4232-MH 199556 and 6606-4232-64, National Health

Research and Development Program, Canada

Turner, 200057 NR, USA DBT-orientated RCT Patients with BPDtherapy

Tyrer et al., Medical Research Council, UK MACT RCT Patients with recurrent 200358 DSH (including BPD)

van den Bosch Province of Noord-Holland and ZAO DBT RCT Female BPI with or et al., 200259 Health Insurance Company in without comorbid (Verheul et al., Amsterdam, The Netherlands substance abuse200364)

Wilberg et al., Norwegian Research Council, S and JP Group psychotherapy Non-random Patients with BPD199860 Sommer’s Foundation and controlled

Maja-Jonn-Nilsen’s Foundations study (naturalistic follow-up study)

Appendix 3

74 TA

BLE

18

Stud

y ch

arac

teris

tics:

RCT

s

Stud

yD

escr

ipti

on o

f psy

chot

hera

pySt

udy

qual

ity

Co-

ther

apy

or

Com

para

tor

Sam

ple

size

med

icat

ion

Bate

man

and

Fon

agy,

1999

51M

BT c

onsis

ted

of: (

1) o

nce-

wee

kly

indi

vidu

alps

ycho

anal

ytic

al p

sych

othe

rapy

; (2)

thr

ice-

wee

kly

grou

p an

alyt

ical

psy

chot

hera

py;

(3) o

nce-

a-w

eek

expr

essiv

e th

erap

y or

ient

ated

tow

ards

psy

chod

ram

a te

chni

ques

; (4)

a w

eekl

yco

mm

unity

mee

ting;

(5) o

nce-

a-m

onth

mee

ting

with

cas

e ad

min

istra

tor;

(6) m

edic

atio

n re

view

by t

he r

esid

ent

psyc

hiat

rist

Rand

omisa

tion

met

hod:

NR

Blin

ded

asse

ssm

ent:

NR

Pow

er c

alcu

latio

n: N

RLo

ss t

o fo

llow

-up:

yes

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

12/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 7/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 6

/12

Inve

stig

ator

: 0/4

Misc

ella

neou

s: 5

/8To

tal:

34/5

8

Ant

idep

ress

ants

and

antip

sych

otic

dru

gspr

escr

ibed

as

appr

opria

te;

poly

phar

mac

y w

asdi

scou

rage

d. U

ncle

arw

heth

er t

his

rela

tes

tobo

th g

roup

s

TAU

: (1)

reg

ular

psyc

hiat

ric r

evie

ww

ith a

sen

ior

psyc

hiat

rist

whe

nne

cess

ary;

(2

) inp

atie

ntad

miss

ion

asap

prop

riate

; (3

) out

patie

nt a

ndco

mm

unity

follo

w-u

p(e

very

2 w

eeks

by

aco

mm

unity

psyc

hiat

ric n

urse

)

Rand

omise

d: n

= 4

4 (M

BT n

= 2

2,

TAU

n =

22)

Ana

lyse

d: n

= 3

8(M

BT n

= 1

9,

TAU

n =

19)

Koon

s et

al.,

200

152D

BT b

ased

on

bala

nce

and

synt

hesis

of

acce

ptan

ce o

f the

pat

ient

as

he/s

he is

cur

rent

ly,us

ing

valid

atio

n st

rate

gies

, with

the

att

empt

to

get

the

patie

nt t

o ch

ange

, usin

g be

havi

our

ther

apy

stra

tegy

(for

det

ails

see

Line

han

et a

l.,19

9153

)

Rand

omisa

tion

met

hod:

com

pute

rised

ran

dom

num

ber

gene

ratio

nBl

inde

d as

sess

men

t: N

RPo

wer

cal

cula

tion:

yes

Loss

to

follo

w-u

p: y

es

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

12/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 8/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 8

/12

Inve

stig

ator

: 2/4

Misc

ella

neou

s: 3

/8To

tal:

37/5

8

Phar

mac

othe

rapy

: SSR

Is,

moo

d st

abili

ser

and/

orlo

w-d

ose

neur

olep

tic

TAU

: 60

min

utes

of

wee

kly

indi

vidu

alth

erap

y w

ith a

clin

icia

n. P

atie

nts

wer

e al

so o

ffere

don

e or

mor

e of

seve

ral s

uppo

rtiv

ean

dps

ycho

educ

atio

nal

grou

ps t

hat

they

coul

d at

tend

Rand

omise

d n

= 2

8(D

BT n

= 1

3,

TAU

n =

15)

Ana

lyse

d: n

= 2

0(D

BT n

= 1

0,TA

U n

= 1

0) cont

inue

d


75


TA

BLE

18

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f psy

chot

hera

pySt

udy

qual

ity

Co-

ther

apy

or

Com

para

tor

Sam

ple

size

med

icat

ion

Line

han

et a

l., 1

99153

DBT

is a

man

ualis

ed 1

2-m

onth

tre

atm

ent

that

com

bine

s fo

ur m

odul

es: (

1) w

eekl

y in

divi

dual

cogn

itive

beh

avio

ural

psy

chot

hera

py s

essio

nsw

ith t

he p

rimar

y th

erap

ist; (

2) w

eekl

y sk

ills

trai

ning

gro

ups

last

ing

for

2–2.

5h

per

sess

ion;

(3) w

eekl

y su

perv

ision

and

con

sulta

tion

mee

tings

for

the

ther

apist

s; a

nd (4

) tel

epho

neco

nsul

tatio

n, w

here

pat

ient

s ar

e en

cour

aged

to

obta

in c

oach

ing

in t

he a

pplia

nce

of n

ew e

ffect

ive

skill

s by

tel

epho

ning

the

ir pr

imar

y th

erap

ists

eith

er d

urin

g or

out

side

offic

e ho

urs.

Indi

vidu

alth

erap

y fo

cuse

s pr

imar

ily o

n m

otiv

atio

nal i

ssue

s,in

clud

ing

the

mot

ivat

ion

to s

tay

aliv

e an

d to

sta

yin

tre

atm

ent.

Gro

up t

hera

py t

each

es s

elf-

regu

latio

n an

d ch

ange

ski

lls, a

nd s

elf a

nd o

ther

acce

ptan

ce s

kills

. Am

ong

the

cent

ral p

rinci

ples

isD

BT’s

sim

ulta

neou

s fo

cus

on a

pply

ing

both

acce

ptan

ce a

nd v

alid

atio

n st

rate

gies

and

cha

nge

(beh

avio

ural

) str

ateg

ies

to a

chie

ve a

syn

thet

ic(d

iale

ctic

al) b

alan

ce in

pat

ient

func

tioni

ng

Rand

omisa

tion

met

hod:

part

icip

ants

wer

e m

atch

ed o

nth

e nu

mbe

r of

life

time

para

suic

ides

and

psy

chia

tric

hosp

italis

atio

n, a

ge a

nd g

ood

vspo

or c

linic

al p

rogn

osis

Blin

ded

asse

ssm

ent:

blin

d in

depe

nden

t as

sess

orPo

wer

cal

cula

tion:

NR

Loss

to

follo

w-u

p: y

es

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

9/1

4In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 9/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 6

/12

Inve

stig

ator

: 2/4

Misc

ella

neou

s: 4

/8To

tal:

34/5

8

Part

icip

ants

had

to

term

inat

e ot

her

indi

vidu

alps

ycho

ther

apie

s an

dta

per

off p

sych

otro

pic

med

icat

ion

(ant

idep

ress

ants

,ne

urol

eptic

s, a

nxio

lytic

s,an

ticon

vulsa

nts,

seda

tives

, lith

ium

)

TAU

: con

trol

part

icip

ants

wer

egi

ven

alte

rnat

ive

ther

apy

refe

rral

s,us

ually

by

the

orig

inal

refe

rral

sou

rce,

from

whi

ch t

hey

coul

dch

oose

Rand

omise

d: n

=63

(DBT

n=

32,

TAU

n=

31)

Ana

lyse

d: n

=44

(DBT

n=

22,

TAU

n=

22)

Follo

wed

up:

n=

39(D

BT n

=19

, TA

U n

=20

) cont

inue

d

Appendix 3

76 TA

BLE

18

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f psy

chot

hera

pySt

udy

qual

ity

Co-

ther

apy

or

Com

para

tor

Sam

ple

size

med

icat

ion

Line

han

et a

l., 1

99954

DBT

with

rep

lace

men

t m

edic

atio

n. “

Seve

ral

mod

ifica

tions

and

add

ition

s w

ere

adde

d to

stan

dard

DBT

for

use

with

sub

stan

ce a

busin

gpo

pula

tion.

A n

ew s

et o

f “at

tach

men

t st

rate

gies

”w

ere

adde

d to

DBT

. The

se s

trat

egie

s co

nsist

edof

a s

et o

f org

anise

d in

terv

entio

ns d

esig

ned

toin

crea

se t

he p

ositi

ve b

alan

ce o

f the

rapy

and

the

ther

apist

, as

wel

l as

to r

each

out

to

and

bric

kba

ck ‘l

ost’

patie

nts.

” A

‘tra

nsiti

onal

mai

nten

ance

’re

plac

emen

t m

edic

atio

n ph

arm

acot

hera

pypr

otoc

ol w

as a

dded

for

indi

vidu

als

with

stim

ulan

t or

opi

ate

depe

nden

ce

Rand

omisa

tion

met

hod:

part

icip

ants

wer

e m

atch

ed o

nag

e, s

ever

ity o

f dru

gde

pend

ence

, rea

dine

ss t

och

ange

and

glo

bal a

djus

tmen

t Bl

inde

d as

sess

men

t: bl

ind

inde

pend

ent

asse

ssor

Pow

er c

alcu

latio

n: N

RLo

ss t

o fo

llow

-up:

Yes

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

12/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 8/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 8

/12

Inve

stig

ator

: 2/4

Misc

ella

neou

s: 6

/8To

tal:

40/5

8

Seve

ral m

odifi

catio

ns a

ndad

ditio

ns w

ere

adde

d to

stan

dard

DBT

for

use

with

sub

stan

ce-a

busin

gpo

pula

tion

Four

mon

ths

of d

rug

mai

nten

ance

(to

prov

ide

time

for

skill

sac

quisi

tion)

, 4 m

onth

s of

drug

tap

erin

g (fo

r sk

ills

stre

ngth

enin

g) a

nd 4

mon

ths

of n

o dr

ugre

plac

emen

t (fo

r sk

ills

gene

ralis

atio

n). I

llici

tst

imul

ants

wer

e re

plac

edw

ith m

etha

done

. The

max

imum

dos

e of

met

hylp

heni

date

giv

enw

as 2

0 m

g da

ily, a

nd t

hem

axim

um d

ose

ofm

etha

done

giv

en w

as

70 m

g da

ily

TAU

par

ticip

ants

wer

e ei

ther

ref

erre

dto

alte

rnat

ive

subs

tanc

e ab

use

and/

or m

enta

l hea

lthco

unse

llors

and

prog

ram

mes

in t

heco

mm

unity

, or

allo

wed

to

cont

inue

with

the

ir in

divi

dual

psyc

hoth

erap

ists

ifth

ey w

ere

rece

ivin

gse

rvic

e at

the

tim

e of

pret

reat

men

tas

sess

men

t

n=

28(D

BT n

=12

, TA

U n

=16

) cont

inue

d


77


TA

BLE

18

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f psy

chot

hera

pySt

udy

qual

ity

Co-

ther

apy

or

Com

para

tor

Sam

ple

size

med

icat

ion

Line

han

et a

l., 2

00255

DBT

for

subs

tanc

e ab

user

s. T

reat

men

t re

quire

sa

synt

hesis

of v

alid

atio

n to

str

engt

hen

self-

trus

tva

lidat

ion,

red

uce

fear

of s

elf-

gene

rate

d(in

trin

sical

ly m

otiv

ated

) res

pons

e pa

tter

ns, a

ndm

aint

ain

wor

king

alli

ance

, beh

avio

ur t

hera

py t

ote

ach

emot

iona

l reg

ulat

ion,

sel

f-va

lidat

ion

and

skilf

ul r

espo

nses

to

prob

lem

s in

livi

ng, a

nd t

oex

tingu

ish o

r pu

nish

BPD

beh

avio

urs

(incl

udin

gill

icit

drug

use

), an

d di

alec

tics

to c

ount

erac

t rig

idan

d ex

trem

e re

spon

se p

atte

rns

Rand

omisa

tion

met

hod:

part

icip

ants

wer

e m

atch

ed o

nse

verit

y, d

rug

depe

nden

ce,

pres

ence

/abs

ence

of P

D a

ndgl

obal

ass

essm

ent

of fu

nctio

ning

Blin

ded

asse

ssm

ent:

blin

din

depe

nden

t as

sess

orPo

wer

cal

cula

tion:

NR

Loss

to

follo

w-u

p: y

es

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

11/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 8/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 8

/12

Inve

stig

ator

: 4/4

Misc

ella

neou

s: 6

/8To

tal:

41/5

8

Opi

ate-

repl

acem

ent

med

icat

ion:

LA

AM

(met

hado

ne a

ltern

ativ

e);

dosin

g: 9

0/90

/130

mg;

the

max

imum

sch

edul

ew

as 1

10/1

10/1

80m

g

CVT

+12

S re

quire

s a

synt

hesis

of v

alid

atio

nto

str

engt

hen

self-

trus

t, re

duce

fear

of

self-

gene

rate

dre

spon

se p

atte

rns,

decr

ease

aro

usal

,in

crea

se t

heex

perie

nce

ofco

ntro

l, an

d m

aint

ain

wor

king

alli

ance

and

fello

wsh

ip o

f sim

ilar

com

mun

ity s

uch

as12

-Ste

p to

val

idat

ebo

th s

ense

of s

elf a

ndre

cove

ry

n=

23(D

BT n

=11

,C

VT+

12S

n=

12)

Mun

roe-

Blum

and

Mar

zial

i, 19

9556

IGP

base

d on

man

ualis

ed t

rain

ing

proc

edur

e; it

sst

rate

gies

ref

lect

an

inte

rper

sona

l gro

uptr

eatm

ent

appr

oach

gea

red

to a

ddre

ssin

g a

cent

ral f

eatu

re o

f the

BPD

Rand

omisa

tion

met

hod:

rand

omise

d ov

er fi

ve w

aves

(unc

lear

)Bl

inde

d as

sess

men

t: in

depe

nden

tas

sess

orPo

wer

cal

cula

tion:

yes

Loss

to

follo

w-u

p: y

es

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

11/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 7/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 6

/12

Inve

stig

ator

: 2/4

Misc

ella

neou

s: 4

/8To

tal:

34/5

8

NR

Indi

vidu

alps

ycho

dyna

mic

psyc

hoth

erap

yco

nsist

ing

of o

pen-

ende

d, in

divi

dual

,dy

nam

icps

ycho

ther

apy;

the

typi

cal m

odel

of

trea

tmen

t of

fere

d to

patie

nts

with

BPD

Rand

omise

d n

=79

(IGP

n=

38,

indi

vidu

al n

=41

)

Ana

lyse

d: n

=48

(IGP

n=

22;

indi

vidu

al n

=26

)

cont

inue

d

Appendix 3

78 TA

BLE

18

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f psy

chot

hera

pySt

udy

qual

ity

Co-

ther

apy

or

Com

para

tor

Sam

ple

size

med

icat

ion

Turn

er, 2

00057

DBT

-orie

ntat

ed t

hera

py w

hich

had

tw

om

odifi

catio

ns m

ade

to L

ineh

an’s

DBT

app

roac

h:(1

) psy

chod

ynam

ic t

echn

ique

s w

ere

inco

rpor

ated

to

conc

eptu

alise

the

pat

ient

’sbe

havi

oura

l, em

otio

nal a

nd c

ogni

tive

rela

tions

hip

sche

ma;

(2) i

n or

der

to k

eep

trea

tmen

tco

nditi

ons

equa

l with

reg

ard

to c

linic

al c

onta

ctho

urs,

the

aut

hors

did

not

run

a s

epar

ate

DBT

skill

s tr

aini

ng g

roup

, but

pro

vide

d sk

ills

durin

gth

e co

urse

of i

ndiv

idua

l the

rapy

Rand

omisa

tion

met

hod:

NR

Blin

ded

asse

ssm

ent:

blin

din

depe

nden

t as

sess

orPo

wer

cal

cula

tion:

NR

Loss

to

follo

w-u

p: n

one

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

12/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 8/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 8

/12

Inve

stig

ator

: 0/4

Misc

ella

neou

s: 5

/8To

tal:

37/5

8

19 p

atie

nts

wer

e ta

king

pres

crib

ed p

sych

otro

pic

med

icat

ions

at

the

begi

nnin

g of

the

stu

dy.

The

re w

as n

o co

nsist

ent

patt

ern

of m

edic

atio

nty

pes

CC

T b

ased

on

Car

nuff

’s m

odel

s of

CC

T, e

mph

asisi

ngem

phat

icun

ders

tand

ing

of t

hepa

tient

’s s

ense

of

alon

enes

s an

dpr

ovid

ing

asu

ppor

tive

atm

osph

ere

for

indi

vidu

atio

n. C

CT

did

not

use

ast

ruct

ured

age

nda.

Inst

ead,

the

rapi

sts

inst

ruct

ed p

atie

nts

toex

pres

s w

hat

was

on

thei

r m

inds

at

each

sess

ion

n=

24(D

BT n

=12

, TA

U n

=12

)

Tyre

r et

al.,

200

358M

AC

T is

70-

page

boo

klet

, offe

ring

up t

o se

ven

trea

tmen

t se

ssio

ns w

ith a

the

rapi

st w

ho h

asbe

en t

rain

ed in

adv

ance

in t

he M

AC

T m

etho

ds

Rand

omisa

tion

met

hod:

str

atifi

edby

cen

tre

and

base

line

para

suic

ide

risk

scor

e an

dal

loca

ted

rand

omly

by

tele

phon

e/fa

xBl

inde

d as

sess

men

t: N

RPo

wer

cal

cula

tion:

yes

Loss

to

follo

w-u

p: y

es

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

12/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 8/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 1

2/12

Inve

stig

ator

: 2/4

Misc

ella

neou

s: 4

/8To

tal:

42/5

8

NR

TAU

pat

ient

sno

rmal

ly r

ecei

ve a

nin

itial

psy

chia

tric

asse

ssm

ent

follo

wed

by p

sych

iatr

icou

tpat

ient

car

e,oc

casio

nal d

ay-

patie

nt c

are

orre

ferr

al b

ack

to t

heG

P, de

pend

ing

on t

hear

rang

emen

ts o

f the

hosp

ital.

If pa

tient

sw

ere

alre

ady

unde

rps

ychi

atric

car

e an

yfu

rthe

r tr

eatm

ent

was

per

mitt

ed, a

part

from

MA

CT

n=

480

(MA

CT

n=

239,

TAU

n=

241)

Of t

hese

, PD

n=

391,

BPD

n=

67 cont

inue

d


79


TA

BLE

18

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f psy

chot

hera

pySt

udy

qual

ity

Co-

ther

apy

or

Com

para

tor

Sam

ple

size

med

icat

ion

van

den

Bosc

h et

al.,

2002

59D

BT (f

or d

etai

ls se

e Li

neha

n et

al.,

199

153)

Rand

omisa

tion

met

hod:

min

imisa

tion

met

hod

mat

ched

by a

ge, a

lcoh

ol, d

rug

and

soci

alpr

oble

ms

Blin

ded

asse

ssm

ent:

inde

pend

ent

asse

ssor

sa

Pow

er c

alcu

latio

n: N

RLo

ss t

o fo

llow

-up:

yes

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

12/

14In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 8/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 9

/12

Inve

stig

ator

: 2/4

Misc

ella

neou

s: 5

/8To

tal:

40/5

8

Thr

ee-q

uart

ers

of t

hepa

tient

s re

port

ed u

se o

fm

edic

atio

n fr

om o

ne o

rm

ore

of t

he fo

llow

ing

cate

gorie

s:be

nzod

iaze

pine

s, S

SRIs

(DBT

52%

, TA

U 6

1%),

tric

yclic

ant

idep

ress

ants

,m

ood

stab

ilise

rs a

ndne

urol

eptic

s

TAU

con

siste

d of

clin

ical

man

agem

ent

from

the

orig

inal

refe

rral

sou

rce

(add

ictio

n tr

eatm

ent

cent

res

n=

11,

psyc

hiat

ric s

ervi

ces

n=

20).

Patie

nts

atte

nded

no

mor

eth

an t

wo

sess

ions

per

mon

th w

ith a

psyc

holo

gist

, aps

ychi

atris

t or

aso

cial

wor

ker

Rand

omise

d: n

=58

(DBT

n=

27,

TAU

n=

31)

Ana

lyse

d: n

=47

(DBT

n=

23,

TAU

n=

24)

a In

depe

nden

t as

sess

ors

wer

e no

t in

form

ed a

bout

the

tre

atm

ent

cond

ition

of t

he in

terv

iew

ees;

how

ever

, pat

ient

s m

ight

hav

e gi

ven

the

info

rmat

ion

abou

t tr

eatm

ent.

LAA

M, l

evo-

alph

a ac

etyl

met

hado

l; SS

RI, s

elec

tive

sero

toni

n re

upta

ke in

hibi

tors

.

Appendix 3

80 TA

BLE

19

Stud

y ch

arac

teris

tics:

non

-RCT

Stud

yD

escr

ipti

on o

f psy

chot

hera

pySt

udy

qual

ity

Co-

ther

apy

or

Com

para

tor

Sam

ple

size

med

icat

ion

Wilb

erg

et a

l.,19

9860

Day

hos

pita

l tre

atm

ent

and,

pos

tdisc

harg

e,gr

oup

anal

ytic

al t

hera

py. T

he d

ay t

reat

men

tpr

ogra

mm

e co

nsist

s of

a c

ombi

natio

n of

indi

vidu

al a

nd g

roup

psy

chot

hera

pies

and

phar

mac

othe

rapy

, con

duct

ed in

acc

orda

nce

with

the

rape

utic

com

mun

ity p

rinci

ples

. The

subs

eque

nt o

utpa

tient

gro

up t

hera

py w

asco

nduc

ted

in a

ccor

danc

e w

ith g

roup

anal

ytic

al p

rinci

ples

Com

para

tor

and

drop

outs

desc

ribed

. Bas

elin

e co

mpa

rabi

lity

not

just

ified

. Ana

lyse

s do

nere

tros

pect

ivel

y

Lack

ner Q

ualit

y Ra

ting

Scal

e ite

ms

Patie

nt s

elec

tion:

9/1

4In

terv

entio

n: 4

/8O

utco

me

mea

sure

men

t: 8/

12D

ata

pres

enta

tion

and

stat

istic

alan

alys

is: 3

/12

Inve

stig

ator

: 2/4

Misc

ella

neou

s: 4

/8To

tal:

30/5

8

NR

Day

hos

pita

ltr

eatm

ent

and,

post

disc

harg

e, T

AU

“ran

ging

from

no

trea

tmen

t to

psyc

hoth

erap

y tw

ice

wee

kly”

n =

43

(tre

atm

ent

grou

p n

= 1

2,co

ntro

l gro

up

n =

31)


81


TA

BLE

20

Ther

apy

deta

ils: R

CTs

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

P

rofe

ssio

nal

betw

een

sess

ions

back

grou

nd o

f the

rapi

st

Bate

man

and

Fona

gy, 1

99951

Patie

nts

from

gen

eral

psyc

hiat

ric s

ervi

ces

refe

rred

durin

g 19

93 a

nd 1

994

(1) O

nce-

wee

kly

indi

vidu

alps

ycho

anal

ytic

al p

sych

othe

rapy

; (2

) thr

ice-

wee

kly

grou

p an

alyt

ical

psyc

hoth

erap

y; (3

) onc

e-a-

wee

kex

pres

sive

ther

apy

orie

ntat

edto

war

ds p

sych

odra

ma

tech

niqu

es;

(4) a

wee

kly

com

mun

ity m

eetin

g;

(5) o

nce-

a-m

onth

mee

ting

with

cas

ead

min

istra

tor;

(6) m

edic

atio

n re

view

by t

he r

esid

ent

psyc

hiat

rist

(1) 1

hou

r; (2

) 1 h

our

each

; (3

) 1ho

ur; (

4) 1

hour

;(5

)1ho

ur. T

he a

vera

ge le

ngth

of

stay

was

1.4

5 ye

ars

TAU

: (1)

reg

ular

psy

chia

tric

,re

view

by

seni

or p

sych

iatr

istw

hen

nece

ssar

y (t

wic

e pe

rw

eek)

; (2)

inpa

tient

adm

issio

n as

appr

opria

te (a

dmiss

ion

rate

90%

, ave

rage

sta

y 11

.6 d

ays)

;(3

) out

patie

nt a

nd c

omm

unity

follo

w-u

p (v

isit

ever

y 2

wee

ksby

a c

omm

unity

psy

chia

trist

)

Part

ial h

ospi

talis

atio

n:th

erap

ies

and

patie

nt–s

taff

cont

act

wer

e or

gani

sed

inac

cord

ance

with

the

psyc

hoan

alyt

ical

mod

el

All

ther

apy

was

giv

en b

yps

ychi

atric

nur

ses

who

wer

em

embe

rs o

f the

par

tial

hosp

italis

atio

n pr

ogra

mm

e’s

team

, but

who

had

no

form

alps

ycho

ther

apy

qual

ifica

tion

Koon

s et

al.,

2001

52D

urha

m V

A M

edic

al C

entr

ean

d Ve

tera

ns R

eadj

ustm

ent

and

Cou

nsel

ling

Cen

tre

inon

e ca

se

DBT

: wee

kly

for

6 m

onth

s;

TAU

: wee

kly

indi

vidu

al t

hera

py fo

r6

mon

ths

DBT

: 90

min

utes

/wee

k;

TAU

: 60

min

utes

per

wee

kTe

leph

one

calls

with

the

prim

ary

ther

apist

(whe

n ne

eded

)

DBT

: psy

chia

trist

, tw

ops

ycho

logi

sts,

a c

linic

al s

ocia

lw

orke

r an

d a

clin

ical

nur

sesp

ecia

list

in p

sych

iatr

y.C

linic

ians

had

a m

ean

of 8

.2ye

ars

of c

linic

al e

xper

ienc

e.A

ll ex

cept

one

att

ende

din

tens

ive

trai

ning

in D

BT

TAU

: thr

ee p

sych

olog

ists,

two

resid

ent

psyc

hiat

rists

,tw

o cl

inic

al s

ocia

l wor

kers

and

a cl

inic

al n

urse

spe

cial

istin

psy

chia

try.

The

y ha

d a

mea

n of

10.

6 ye

ars

of c

linic

alex

perie

nce.

Fou

r de

scrib

edth

emse

lves

as

cogn

itive

beha

viou

ral,

two

asps

ycho

dyna

mic

and

tw

o as

ecle

ctic

in t

heir

prim

ary

orie

ntat

ion

cont

inue

d

Appendix 3

82 TA

BLE

20

Ther

apy

deta

ils: R

CTs

(con

t’d)

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

P

rofe

ssio

nal

betw

een

sess

ions

back

grou

nd o

f the

rapi

st

Line

han

et a

l.,19

9153

Part

icip

ants

wer

e cl

inic

ally

refe

rred

and

vol

unta

rily

enro

lled

in t

he s

tudy

DBT

: ind

ivid

ual t

hera

py w

assc

hedu

led

for

wee

kly

1-ho

urse

ssio

n. G

roup

the

rapy

was

sche

dule

d on

ce e

ach

wee

k fo

r2.

5ho

urs

(for

1 ye

ar);

cont

rol

grou

p: N

R

Indi

vidu

al s

essio

n 1-

hour

; gro

upse

ssio

n 2.

5 ho

urs

Tele

phon

e co

ntac

tw

ith t

he in

divi

dual

ther

apist

bet

wee

nse

ssio

ns w

as p

art

ofD

BT. T

he g

roup

ther

apist

did

not

acce

pt t

elep

hone

calls

from

pat

ient

s,an

d pa

tient

cris

esw

ere

refe

rred

to

the

indi

vidu

al t

hera

pist

Expe

rienc

ed g

radu

ate

psyc

holo

gy s

tude

nts,

ther

apist

s w

ith m

aste

r’s

leve

ltr

aini

ng a

nd c

linic

alps

ycho

logi

sts

Line

han

et a

l.,19

9954

Part

icip

ants

wer

e re

ferr

ed t

oth

e pr

ogra

mm

e by

are

acl

inic

ians

Wee

kly

indi

vidu

al p

sych

othe

rapy

(1ho

ur),

grou

p sk

ills

trai

ning

ses

sion

(2ho

urs

plus

a 1

5-m

inut

e w

ind-

dow

n) (f

or 1

yea

r)

Indi

vidu

al s

essio

n 1-

hour

; gro

upse

ssio

n 2

hour

s pl

us a

15-

min

ute

win

d-do

wn

Skill

s co

achi

ngte

leph

one

calls

with

the

prim

ary

ther

apist

(whe

n ne

eded

)

DBT

: tw

o ps

ycho

logi

sts,

one

psyc

hiat

rist

and

two

mas

ter’

sle

vel c

linic

ians

TAU

: of 1

5 th

erap

ists

inte

rvie

wed

, fiv

e w

ere

psyc

hoth

erap

ists,

eig

htm

aste

r’s

leve

l the

rapi

sts

and

two

had

no o

r un

know

nhe

alth

deg

ree

(tw

obe

havi

oura

l, th

ree

cogn

itive

,fiv

e C

CT

or

supp

ortiv

e, o

neps

ycho

dyna

mic

, one

ecl

ectic

)

cont

inue

d


83


TA

BLE

20

Ther

apy

deta

ils: R

CTs

(con

t’d)

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

P

rofe

ssio

nal

betw

een

sess

ions

back

grou

nd o

f the

rapi

st

Line

han

et a

l.,20

0255

Part

icip

ants

wer

e re

crui

ted

from

men

tal h

ealth

clin

ics,

need

le e

xcha

nge

prog

ram

mes

, sub

stan

ceab

use

clin

ics,

met

hado

nem

aint

enan

ce c

linic

s an

d no

n-pr

ofit

HIV

/AID

S pr

even

tion

orga

nisa

tions

tre

atin

gun

ders

erve

d m

inor

itypo

pula

tions

DBT

or

CVT

+12

S pl

us a

n op

iate

med

icat

ion

for

appr

oxim

atel

y 1

year

(48–

56 w

eeks

)

DBT

: ind

ivid

ual D

BT40

–90

min

utes

per

wee

k; g

roup

skill

s tr

aini

ng 1

50m

inut

es p

erw

eek;

indi

vidu

al s

kills

coa

chin

g30

min

utes

per

wee

k(r

ecom

men

ded)

; 12S

and

oth

ersu

ppor

tive

grou

p m

eetin

gs(r

ecom

men

ded)

;D

BT c

ase

man

agem

ent

thro

ugho

ut 1

yea

r(4

8–56

wee

ks)

CVT

+12

S: in

divi

dual

CVT

+12

S40

–90

min

utes

per

wee

k; ‘1

2-an

d-12

’ Nar

cotic

s A

nony

mou

sgr

oup

120

min

ute

per

wee

k;12

S sp

onso

r m

eetin

g; 1

2Sm

eetin

g (r

ecom

men

ded)

;C

VT+

12S

case

man

agem

ent

(as

need

ed) t

hrou

ghou

t 1

year

(48–

56w

eeks

)

Tele

phon

eco

nsul

tatio

n an

dcr

isis

inte

rven

tions

Five

the

rapi

sts

(one

mal

e,fo

ur fe

mal

e; t

hree

DBT

and

two

CVT

+12

S): t

wo

doct

oral

leve

l and

one

mas

ter’

s le

vel b

ehav

iour

ther

apist

del

iver

ed D

BT, a

ndtw

o m

aste

r’s

leve

l the

rapi

sts

with

che

mic

al d

epen

denc

yce

rtifi

catio

n an

d 12

Sex

perie

nce

deliv

ered

CVT

+12

S. E

ach

ther

apist

had

a m

inim

um o

f 8 m

onth

trai

ning

, and

had

sup

ervi

sed

trai

ning

clie

nts

in t

heir

resp

ectiv

e m

odal

ities

bef

ore

seei

ng t

heir

rese

arch

clie

nts.

The

rapi

sts

in e

ach

cond

ition

met

wee

kly

with

sup

ervi

sors

to d

iscus

s ca

se m

ater

ials

and

revi

ew s

essio

n vi

deot

apes

Mun

roe-

Blum

and

Mar

zial

i, 19

9556

Part

icip

ants

wer

e re

crui

ted

from

the

inpa

tient

and

outp

atie

nt p

sych

iatr

y un

its o

fth

e te

achi

ng h

ospi

tals

of a

larg

e C

anad

ian

urba

nun

iver

sity

IGP:

30

sess

ions

of t

reat

men

t(2

5w

eekl

y se

ssio

ns fo

llow

ed b

y fiv

etw

ice

wee

kly

sess

ions

lead

ing

into

term

inat

ion)

Each

ses

sion

sche

dule

d fo

r1.

5ho

urs

NR

All

ther

apist

s w

ere

trai

ned

tous

e IG

P

cont

inue

d

Appendix 3

84 TA

BLE

20

Ther

apy

deta

ils: R

CTs

(con

t’d)

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

P

rofe

ssio

nal

betw

een

sess

ions

back

grou

nd o

f the

rapi

st

Turn

er, 2

00057

Patie

nts

from

loca

l hos

pita

lem

erge

ncy

serv

ices

wer

ere

ferr

ed t

o th

e co

mm

unity

men

tal h

ealth

out

patie

ntcl

inic

Min

imum

49

and

max

imum

84

sess

ions

Six

grou

p se

ssio

ns w

ere

prov

ided

to

patie

nts

in b

oth

trea

tmen

tco

nditi

ons

CC

T: t

reat

men

t w

as s

ched

uled

for

12 m

onth

s. S

essio

ns w

ere

sche

dule

dtw

ice

per

wee

k w

hen

poss

ible

NR

In C

CT

gro

up d

urin

gth

e cr

isis

man

agem

ent

phas

e,th

e th

erap

ist m

etpa

tient

s as

ofte

n as

thre

e tim

es a

wee

k

The

rapi

sts

cond

uctin

g bo

thtr

eatm

ents

had

an

aver

age

22ye

ars

of e

xper

ienc

e, w

ithth

eore

tical

bac

kgro

unds

infa

mily

sys

tem

, clie

nt-c

entr

edan

d ps

ycho

dyna

mic

trea

tmen

ts. D

BT t

rain

ing

last

ed fo

r 3

mon

ths

(12

sess

ions

, eac

h se

ssio

nla

sted

for

90 m

inut

es)

Tyre

r et

al.,

200

358Pa

rtic

ipan

ts w

ere

recr

uite

din

nin

e A

&E

depa

rtm

ents

infiv

e U

K s

tudy

cen

tres

:G

lasg

ow, E

dinb

urgh

,N

ottin

gham

, Wes

t Lo

ndon

and

Sout

h Lo

ndon

Up

to fi

ve s

essio

ns w

ithin

3m

onth

saf

ter

a se

lf-ha

rm e

piso

de, w

ith t

heop

tion

of t

wo

addi

tiona

l boo

ster

sess

ions

with

in 6

mon

ths

NR

Betw

een

sess

ions

,th

e m

anua

l act

s as

an

aide

-mém

oire

and

can

be u

sed

for

hom

ewor

k ta

sks

byth

e pa

tient

NR

van

den

Bosc

het

al.,

2002

59Re

ferr

als

orig

inat

ed fr

omad

dict

ion

trea

tmen

t se

rvic

es,

psyc

hiat

ric h

ospi

tals,

cen

tres

for

men

tal h

ealth

care

,in

depe

nden

tly w

orki

ngps

ycho

logi

sts

and

psyc

hiat

rists

, GPs

and

sel

f-re

ferr

al

Wee

kly

sess

ion

durin

g 12

mon

ths

DBT

: 2–2

.5ho

urs;

TA

U: n

om

ore

than

tw

o se

ssio

ns p

erm

onth

(len

gth

of s

essio

ns n

otre

port

ed)

Tele

phon

e ca

lls w

ithth

e pr

imar

y th

erap

ist(w

hen

need

ed)

Four

psy

chia

trist

s an

d 12

clin

ical

psy

chol

ogist

s (t

wo

with

mas

ter’

s de

gree

s an

don

e a

PhD

). G

roup

tra

inin

gw

as c

ondu

cted

in t

hree

sepa

rate

gro

ups

led

join

tly b

yso

cial

wor

kers

and

clin

ical

psyc

holo

gist

s. A

cor

e gr

oup

of t

hree

the

rapi

sts

was

sen

tto

Sea

ttle

to

be t

rain

ed in

DBT


85


TA

BLE

21

Ther

apy

deta

ils: n

on-R

CT

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

P

rofe

ssio

nal

betw

een

sess

ions

back

grou

nd o

f the

rapi

st

Wilb

erg

et a

l.,19

9860

Patie

nts

bein

g tr

eate

d at

the

Day

Uni

t, U

llevå

l Uni

vers

ityH

ospi

tal

Onc

e a

wee

k fo

r a

mea

n pe

riod

of12

mon

ths

(ran

ge 1

–33

mon

ths)

1.5

hour

sN

R“S

ix o

f the

eig

ht t

hera

pist

sw

ere

in g

roup

ana

lytic

altr

aini

ng a

t th

e tim

e”

Appendix 3

86 TA

BLE

22

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

Stud

ySt

udy

site

Leng

th o

f N

umbe

rs lo

st t

o R

easo

ns fo

r lo

ss t

o In

clus

ion

crit

eria

Excl

usio

n cr

iter

iafo

llow

-up

follo

w-u

pfo

llow

-up/

drop

out

cont

inue

d

Bate

man

and

Fona

gy, 1

99951

Hal

liwic

kPs

ycho

ther

apy

Uni

t, w

hich

is p

art

of t

he g

ener

alps

ychi

atric

serv

ices

, UK

(PH

)

18 m

onth

sO

f 44

elig

ible

pat

ient

s,6

drop

ped

out

durin

gth

e st

udy.

No

loss

to

follo

w-u

p in

PH

gro

upan

d th

ree

in T

AU

With

in t

he fi

rst

mon

th t

hree

pat

ient

sfr

om t

he c

ontr

ol g

roup

cro

ssed

ove

rin

to t

he P

H g

roup

afte

r se

rious

sui

cide

atte

mpt

. With

in 6

mon

ths

thre

e pa

tient

sdr

oppe

d ou

t fr

om t

he P

H g

roup

(rea

son

NR)

BPD

pat

ient

s w

ho s

core

d 7

orm

ore

on (1

) SC

ID fo

r D

SM-II

I-R a

nd (2

) the

Dia

gnos

tic In

terv

iew

for

BPD

Schi

zoph

reni

a, b

ipol

ardi

sord

er, s

ubst

ance

misu

se,

men

tal i

mpa

irmen

t or

orga

nic

brai

n di

sord

er

Koon

s et

al.,

2001

52M

edic

al C

entr

e,U

SA (o

utpa

tient

sett

ing)

No

follo

w-u

pTw

o di

d no

t at

tend

the

first

app

oint

men

t, on

edr

oppe

d ou

t af

ter

first

appo

intm

ent,

two

inTA

U a

nd t

hree

in D

BTdr

oppe

d ou

t of

trea

tmen

t af

ter

atte

ndin

g m

ore

than

one

sess

ion

Loss

of t

rans

port

atio

n an

d di

stan

cefr

om t

he m

edic

al c

entr

e. O

ne d

ropp

edou

t w

hen

she

real

ised

she

wou

ld o

nly

be p

aid

for

asse

ssm

ents

, not

for

atte

ndin

g tr

eatm

ent

Wom

en v

eter

ans

who

met

DSM

-III-R

crit

eria

for

BPD

Schi

zoph

reni

a, b

ipol

ardi

sord

er, s

ubst

ance

depe

nden

ce o

r an

tisoc

ial

pers

onal

ity d

isord

er

Line

han

et a

l.,19

9153

Rese

arch

clin

ic,

USA

(out

patie

ntse

ttin

g)

1 ye

ar19

(dro

pout

s du

ring

the

trea

tmen

t pe

riod)

Five

(dur

ing

1 ye

ar o

ffo

llow

-up)

Ten

(DBT

n=

5, T

AU

n=

5) d

ropp

edou

t du

ring

pret

reat

men

t as

sess

men

t; Se

ven

(DBT

n=

3, T

AU

n=

4)dr

oppe

d ou

t ow

ing

to r

efus

al o

r in

abili

tyto

mee

t st

udy

cond

ition

s; t

wo

(DBT

)qu

it af

ter

four

or

few

er s

essio

ns

(1) S

core

d at

leas

t 7,

out

of a

max

imum

of 1

0, o

n th

e D

IB;

(2) M

et D

MS-

III c

riter

ia fo

rBP

D; (

3) h

ad a

t le

ast

two

inci

denc

es o

f par

asui

cide

in t

hepa

st 5

yea

rs, w

ith o

ne d

urin

gth

e pa

st 8

wee

ks; (

4) w

omen

aged

18–

45ye

ars

Men

; par

ents

who

met

DSM

-III c

riter

ia fo

rsc

hizo

phre

nia,

bip

olar

diso

rder

, sub

stan

cede

pend

ence

or

men

tal

reta

rdat

ion

Line

han

et a

l.,19

9954

Rese

arch

clin

ic,

USA

(out

patie

ntse

ttin

g)

16 m

onth

s (4

mon

ths

post

-tr

eatm

ent)

12Si

x (D

BT n

=1,

TA

U n

=5

)pa

rtic

ipan

ts d

ropp

ed b

efor

e or

imm

edia

tely

afte

r pr

etre

atm

ent

asse

ssm

ent;

two

(DBT

) par

ticip

ants

drop

ped

out

by t

he s

ixth

ses

sion;

tw

o(D

BT) p

rovi

ded

no d

ata

afte

rpr

etre

atm

ent;

one

drop

ped

out

oftr

eatm

ent

afte

r th

e six

th s

essio

n; o

nedi

ed o

f acc

iden

tal d

rug

over

dose

dur

ing

the

4-m

onth

ass

essm

ent

Part

icip

ants

who

met

crit

eria

for

BPD

on

both

PD

E an

d th

eSC

ID-II

and

met

crit

eria

for

subs

tanc

e us

e di

sord

er fo

rop

iate

s, c

ocai

ne,

amph

etam

ines

, sed

ativ

es,

hypn

otic

s, a

nxio

lytic

s or

poly

subs

tanc

e us

e di

sord

er o

nth

e SC

ID

Part

icip

ants

who

met

crite

ria fo

r sc

hizo

phre

nia

and

othe

r ps

ycho

ticdi

sord

er, o

r bi

pola

r m

ood

diso

rder

on

the

SCID

, or

men

tal r

etar

datio

n on

the

Peab

ody

Pict

ure

Voca

bula

ryTe

st–R

evise

d


87


TA

BLE

22

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

(con

t’d)

Stud

ySt

udy

site

Leng

th o

f N

umbe

rs lo

st t

o R

easo

ns fo

r lo

ss t

o In

clus

ion

crit

eria

Excl

usio

n cr

iter

iafo

llow

-up

follo

w-u

pfo

llow

-up/

drop

out

cont

inue

d

Line

han

et a

l.,20

0255

Rese

arch

clin

ic,

USA

(out

patie

ntse

ttin

g)

16 m

onth

s(4

mon

ths

post

-tr

eatm

ent)

DBT

: 36%

loss

to

follo

wup C

VD+

12S:

no

loss

to

follo

w-u

p

NR

(1) W

omen

age

d 18

–45

year

s;(2

) dia

gnos

is of

BPD

acc

ordi

ngto

tw

o st

ruct

ured

inte

rvie

ws:

PDE

and

SCID

-II; (

3) d

iagn

osis

of c

urre

nt o

piat

e de

pend

ence

acco

rdin

g to

SC

ID-I

Bipo

lar

diso

rder

, psy

chos

is,se

izur

e di

sord

er, o

r m

enta

lre

tard

atio

n; p

regn

ancy

or

any

othe

r m

edic

al c

ondi

tion

in w

hich

the

use

of o

piat

e-re

plac

emen

t m

edic

atio

n w

asco

ntra

indi

cate

d; in

dica

tions

of c

oerc

ion

(e.g

. cou

rtor

dere

d/ag

ency

ord

ered

to

reta

in h

ousin

g)

Mun

roe-

Blum

and

Mar

zial

i,19

9556

Out

patie

ntho

spita

ls, C

anad

a(o

utpa

tient

sett

ing)

24 m

onth

s31

with

drew

at

the

poin

t of

ran

dom

isatio

nN

R(1

) Men

and

wom

en a

ged

18–6

5 ye

ars;

(2) h

ad a

t le

ast

one

prio

r ps

ychi

atric

con

tact

and

met

BPD

crit

eria

on

the

DIB

, cut

-off

scor

e ≥

7

Lang

uage

diff

icul

ty;

neur

olog

ical

impa

irmen

t or

men

tal r

etar

datio

n; a

prim

ary

diag

nosis

of a

lcoh

olor

dru

g ad

dict

ion;

phy

sical

diso

rder

s w

ith k

now

nps

ychi

atric

con

sequ

ence

s

Turn

er, 2

00057

Out

patie

nt c

linic

,U

SA (o

utpa

tient

sett

ing)

12 m

onth

sD

BT: n

= 4

, C

CT:

n=

6

NR

(one

pat

ient

in D

BT g

roup

ret

urne

daf

ter

5-w

eeks

bre

ak)

(1) M

et d

iagn

ostic

crit

eria

for

BPD

; (2)

gav

e in

form

edco

nsen

t; (3

) acc

epte

d ra

ndom

assig

nmen

t

Schi

zoph

reni

a,sc

hizo

affe

ctiv

e di

sord

er,

bipo

lar

diso

rder

, org

anic

men

tal d

isord

er o

r m

enta

lre

tard

atio

n

Tyre

r et

al.,

2003

58Pa

tient

s fr

om t

heho

spita

ls in

Gla

sgow

,Ed

inbu

rgh,

Not

tingh

am, W

est

Lond

on a

nd S

outh

Lond

on b

etw

een

May

198

8 an

dA

pril

2000

, UK

(out

patie

ntse

ttin

g)

12 m

onth

sM

AC

T n

= 4

0,

TAU

n =

38

MA

CT

TA

Un

= 3

n =

5 d

ied

n =

14

n =

13

not

trac

edn

= 9

n =

10

refu

sed

asse

ssm

ent

n =

4n

= 0

with

drew

n =

3n

= 6

did

not

att

end

n =

7n

= 4

oth

er r

easo

n

(1) P

atie

nts

who

had

had

apr

evio

us e

piso

de o

f DSH

; (2

) gav

e in

form

ed w

ritte

nco

nsen

t; (3

) did

not

req

uire

inpa

tient

psy

chia

tric

tre

atm

ent;

(4) a

ged

betw

een

16 a

nd65

year

s, (5

) pre

sent

ed t

o A

&E

afte

r an

epi

sode

of D

SH

Psyc

hotic

or

bipo

lar

diso

rder

; prim

ary

diag

nosis

of s

ubst

ance

dep

ende

nce;

insu

ffici

ent

know

ledg

e of

Engl

ish; t

empo

rary

resid

ence

Appendix 3

88 TA

BLE

22

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

(con

t’d)

Stud

ySt

udy

site

Leng

th o

f N

umbe

rs lo

st t

o R

easo

ns fo

r lo

ss t

o In

clus

ion

crit

eria

Excl

usio

n cr

iter

iafo

llow

-up

follo

w-u

pfo

llow

-up/

drop

out

van

den

Bosc

het

al.,

200

259Je

lline

k A

ddic

tion

Trea

tmen

t C

entr

ein

Am

ster

dam

,T

he N

ethe

rland

s(o

utpa

tient

sett

ing)

18 m

onth

sO

f 58

elig

ible

pat

ient

s,six

drop

ped

out

durin

gth

e st

udy

DBT

: n=

4 re

fuse

d to

sta

rt t

reat

men

tTA

U: n

=2

did

not

acce

ptTA

U c

ondi

tion

(1) M

et D

SM-IV

crit

eria

for

BPD

; (2)

cur

rent

ly in

outp

atie

nt p

sych

iatr

ic o

rsu

bsta

nce

abus

e tr

eatm

ent;

(3) w

omen

age

d 18

–70

year

s;(4

) res

iden

ce w

ithin

40-

kmci

rcle

aro

und

Am

ster

dam

DSM

-IV c

riter

ia fo

r bi

pola

rdi

sord

er o

r (c

hron

ic)

psyc

hotic

diso

rder

;in

suffi

cien

t co

mm

and

ofD

utch

lang

uage

; sev

ere

cogn

itive

impa

irmen

ts

TA

BLE

23

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: n

on-R

CT

Stud

ySt

udy

site

Leng

th o

f N

umbe

rs lo

st t

o R

easo

ns fo

r lo

ss t

o In

clus

ion

crit

eria

Excl

usio

n cr

iter

iafo

llow

-up

follo

w-u

pfo

llow

-up/

drop

out

Wilb

erg

et a

l.,19

9860

Day

Psy

chia

tric

Uni

t in

Uni

vers

ityH

ospi

tal,

Oslo

,N

orw

ay

An

aver

age

of 3

4 m

onth

spo

stdi

scha

rge

from

day

hosp

ital

Non

e. R

etro

spec

tive

stud

yN

RM

et D

SM-II

I/DSM

-IIIR

crit

eria

for

BPD

Patie

nts

with

sch

izot

ypal

pers

onal

ity d

isord

er;

patie

nts

who

had

sta

yed

for

less

tha

n 3

wee

ks a

t th

e da

yho

spita

l


89


TA

BLE

24

Patie

nt c

hara

cter

istic

s: R

CTs

Stud

yM

etho

ds fo

r di

agno

sis

Age

Gen

der

Ethn

icit

yEd

ucat

ion/

soci

o-ec

onom

ic

Pati

ent

hist

ory

Bas

elin

e co

mpa

rabi

lity

of d

isor

der

(yea

rs)

back

grou

nd

cont

inue

d

Bate

man

and

Fona

gy, 1

99951

(1) S

CID

for

DSM

-III;

(2) D

iagn

ostic

Inte

rvie

wfo

r BP

D

16–6

5F

n=

22M

n=

16N

RC

olle

ge: P

H n

= 7

, TA

U n

= 3

Une

mpl

oyed

: PH

n=

19,

TA

U n

= 1

9Si

ngle

: PH

n=

17,

TA

U n

= 1

6Sh

elte

red

acco

mm

odat

ion:

PH

n=

3, T

AU

n=

2W

ith fa

mily

of o

rigin

: PH

n=

6,

TAU

n=

3A

lone

: PH

n=

10,

TA

U n

= 1

4

Early

mat

erna

l los

s:

PH n

= 1

0, T

AU

n=

14

Repo

rted

sex

ual a

buse

: PH

n=

7, T

AU

n=

8Re

port

ed r

ape:

PH

n=

5,

TAU

n=

2Re

port

ed p

hysic

al a

buse

: PH

n=

9, T

AU

n=

8

The

re w

ere

no s

igni

fican

tdi

ffere

nces

on

any

of t

heba

selin

e m

easu

res

betw

een

the

two

grou

ps

Koon

s et

al.,

2001

52BP

D a

nd a

ntiso

cial

pers

onal

ity d

isord

erse

ctio

ns o

f the

SC

ID-II

for

DSM

-III-R

for

Axi

s II,

and

the

subs

tanc

e ab

use,

bipo

lar

diso

rder

, and

schi

zoph

reni

a se

ctio

ns o

fth

e SC

ID fo

r D

SM-II

I-Rfo

r A

xis

II

Mea

n 35

(21–

46)

FC

auca

sian

75%

;A

fric

an–A

mer

ican

25%

Col

lege

80%

; bac

helo

r’s

degr

eeor

equ

ival

ent

20%

; inc

ome

>$2

0,00

0 pa

70%

; liv

es w

ithpa

rtne

r 55

%

75%

had

a li

fetim

e hi

stor

yof

par

asui

cide

, def

ined

as

any

inte

ntio

nal s

elf-

inju

ry,

incl

udin

g su

icid

e at

tem

pts;

40%

rep

orte

d pa

rasu

icid

albe

havi

our

in t

he 6

mon

ths

befo

re t

he s

tudy

. 55%

had

at le

ast

one

lifet

ime

psyc

hiat

ric a

dmiss

ion;

25%

had

an in

patie

nt p

sych

iatr

icad

miss

ion

in t

he p

ast

6m

onth

s. A

ll ha

d at

leas

ton

e ps

ychi

atric

out

patie

ntvi

sit in

the

pre

viou

s 6

mon

ths.

25%

met

crit

eria

for

subs

tanc

e ab

use,

but

not

depe

nden

ce; 6

0% r

epor

ted

sexu

al a

buse

bef

ore

the

age

of 1

3, 6

5% r

epor

ted

bein

gba

tter

ed b

y a

part

ner

and

85%

rep

orte

d be

ing

rape

das

an

adul

t, 46

% w

hile

on

activ

e m

ilita

ry d

uty

Non

e of

the

var

iabl

esdi

ffere

d sig

nific

antly

betw

een

grou

ps

Appendix 3

90 TA

BLE

24

Patie

nt c

hara

cter

istic

s: R

CTs

(con

t’d)

Stud

yM

etho

ds fo

r di

agno

sis

Age

Gen

der

Ethn

icit

yEd

ucat

ion/

soci

o-ec

onom

ic

Pati

ent

hist

ory

Bas

elin

e co

mpa

rabi

lity

of d

isor

der

(yea

rs)

back

grou

nd

cont

inue

d

Line

han

et a

l.,19

9153

(1) S

core

d at

leas

t 7

out

of a

max

imum

of 1

0 on

the

DIB

; (2)

DM

S-III

crite

ria fo

r BP

D; (

3) h

adat

leas

t tw

o in

cide

nces

of

para

suic

ide

in t

he p

ast

5ye

ars,

with

one

dur

ing

the

past

8 w

eeks

18–4

5F

NR

NR

Patie

nts

with

a h

istor

y of

para

suic

ide

and

psyc

hiat

richo

spita

lisat

ion

on t

hegr

ound

of B

PD

Part

icip

ants

wer

em

atch

ed o

n th

e nu

mbe

rof

life

time

para

suic

ides

and

psyc

hiat

richo

spita

lisat

ion,

age

, and

good

vs.

poo

r cl

inic

alpr

ogno

sis

Line

han

et a

l.,19

9954

Part

icip

ants

wer

e gi

ven

asc

reen

ing

inte

rvie

w t

hat

incl

uded

SC

ID fo

r D

SM-II

I and

the

PD

E

Mea

n30

.4±

6.6

(18–

45)

FEu

rope

an 7

8%;

Afr

ican

–Am

eric

an7%

; Lat

ina

4%;

othe

r 11

%

Hig

h sc

hool

gra

duat

e 22

%,

colle

ge g

radu

ate

63%

; inc

ome:

<$5

000

54%

, $50

00–1

9.99

935

%, $

20,0

00 <

12%

; sin

gle

63%

74%

met

SC

ID c

riter

ia fo

rsu

bsta

nce

depe

nden

ce fo

rm

ore

than

one

dru

g, 5

8%fo

r cu

rren

t co

cain

e ab

use

orde

pend

ence

, and

52%

for

alco

hol d

epen

denc

e. E

ight

part

icip

ants

prim

arily

abu

sed

coca

ine,

six

opi

ates

, fou

rm

ariju

ana,

one

met

ham

phet

amin

e, o

neha

luci

noge

ns, a

nd o

ne b

oth

coca

ine

and

met

ham

phet

amin

e.Pa

rtic

ipan

ts c

omm

only

suffe

red

Axi

s I n

on-

subs

tanc

e us

e di

sord

er(7

9% li

fetim

e; 5

0% c

urre

nt)

and

post

-tra

umat

ic s

tres

sdi

sord

er (3

8% c

urre

nt a

ndlif

etim

e). 1

2% w

ere

diag

nose

d w

ith a

ntiso

cial

pers

onal

ity d

isord

er

Part

icip

ants

wer

em

atch

ed o

n ag

e, s

ever

ityon

dru

g de

pend

ence

(bas

ed o

n SC

ID r

atin

gs),

read

ines

s to

cha

nge

and

glob

al a

djus

tmen

t (A

xis

V,D

SM-IV

) usin

g a

min

imisa

tion

rand

omas

signm

ent

proc

edur

e


91


TA

BLE

24

Patie

nt c

hara

cter

istic

s: R

CTs

(con

t’d)

Stud

yM

etho

ds fo

r di

agno

sis

Age

Gen

der

Ethn

icit

yEd

ucat

ion/

soci

o-ec

onom

ic

Pati

ent

hist

ory

Bas

elin

e co

mpa

rabi

lity

of d

isor

der

(yea

rs)

back

grou

nd

cont

inue

d

Line

han

et a

l.,20

0255

(1) P

DE;

(2) S

CID

-II fo

rD

SM-IV

; (3)

opi

ate

depe

nden

ce a

ccor

ding

to

SCID

-I

Mea

n36

.1±

7.3

(18–

45)

FC

auca

sian

66%

;A

fric

an–A

mer

ican

26%

; Mix

ed 4

%

Div

orce

d 52

%, m

arrie

d 4%

;ne

ver

been

mar

ried

44%

; hig

hsc

hool

96%

; bus

ines

s/te

chni

cal

scho

ol 4

8%; c

olle

ge 4

%;

grad

uate

or

prof

essio

nal s

choo

lw

ithou

t gr

adua

ting

18%

;em

ploy

ed 5

2%

Dep

ende

nce

on: c

ocai

ne52

%, s

edat

ives

13%

,ca

nnab

is 8.

7%, a

lcoh

ol 2

6%

Co-

mor

bidi

ty: m

ajor

depr

essiv

e di

sord

er o

rdy

sthy

mia

39%

, anx

iety

diso

rder

52%

, eat

ing

diso

rder

18%

65%

of t

he s

ampl

e re

port

eda

hist

ory

of a

t le

ast

one

suic

ide

atte

mpt

or

inte

ntio

nal s

elf-

inju

ry

No

signi

fican

t be

twee

n-gr

oup

diffe

renc

es w

ere

dete

cted

for

diag

nose

s,le

vel o

f gen

eral

func

tioni

ng o

r pa

rasu

icid

eac

ts p

rior

to t

reat

men

t

Mun

roe-

Blum

and

Mar

zial

i,19

9556

DIB

18–5

2F

n =

89;

M

n=

21

NR

Mos

t ha

d co

mpl

eted

hig

h sc

hool

.M

ost

wer

e cu

rren

tly u

nmar

ried,

but

had

had

a pr

ior

mar

riage

or

live-

in r

elat

ions

hip.

Ove

r ha

lf ha

dch

ildre

n, w

ho o

ften

wer

e no

tre

sidin

g w

ith t

hem

. Mos

t ha

d a

hist

ory

of s

ome

form

of

empl

oym

ent,

albe

it in

term

itten

t

One

-thi

rd o

f the

sam

ple

expe

rienc

ed s

igni

fican

tbe

havi

oura

l and

soc

ial

dysf

unct

ion

in t

he 6

mon

ths

befo

re t

reat

men

t; ab

out

half

had

repo

rted

pro

blem

s w

ithth

e la

w a

nd s

ubst

ance

abus

e. 8

5% r

epor

ted

prob

lem

s w

ith im

pulse

cont

rol.

All

part

icip

ants

use

dm

enta

l hea

lth/s

ocia

l ser

vice

s

The

re w

ere

nost

atist

ical

ly s

igni

fican

tdi

ffere

nces

on

clin

ical

and

soci

o-de

mog

raph

ic fa

ctor

sbe

twee

n tw

o gr

oups

or

betw

een

patie

nts

who

rem

aine

d in

the

stu

dy a

ndth

ose

who

with

drew

Turn

er, 2

00057

(1) 9

0-m

inut

e sc

reen

ing

inte

rvie

w b

ased

on

the

DIB

and

SC

ID fo

r D

SM-

III; (

2) P

DE

to c

ross

-va

lidat

e th

e BP

Ddi

agno

sis a

nd d

eter

min

eth

e pr

esen

ce o

fad

ditio

nal A

xis

IIdi

sord

ers

22 (18–

27)

F n

= 1

9;

M n

= 5

Cau

casia

nn

= 1

9;A

fric

an–A

mer

ican

n=

4;

Asia

n–A

mer

ican

n

= 1

Ave

rage

leve

l of e

duca

tion

13.3

year

s (r

ange

12–

16)

23 p

atie

nts

met

crit

eria

for

aco

-mor

bid

Axi

s I d

isord

er;

eigh

t pa

tient

s ha

d a

hist

ory

of b

rief p

sych

otic

or

para

noid

epi

sode

s

Base

line

diffe

renc

e w

asno

t st

atist

ical

ly s

igni

fican

t,�

2 (1) =

2.2

7, p

= 0

.132

Appendix 3

92 TA

BLE

24

Patie

nt c

hara

cter

istic

s: R

CTs

(con

t’d)

Stud

yM

etho

ds fo

r di

agno

sis

Age

Gen

der

Ethn

icit

yEd

ucat

ion/

soci

o-ec

onom

ic

Pati

ent

hist

ory

Bas

elin

e co

mpa

rabi

lity

of d

isor

der

(yea

rs)

back

grou

nd

Tyre

r et

al.,

2003

58IC

D-1

0 di

agno

stic

crite

ria o

f the

per

sona

lity

sche

dule

Mea

n 32

M 3

2%W

hite

90%

(Eng

lish,

Sco

ttish

,W

elsh

)

Mar

ital s

tatu

s: s

ingl

e 55

%,

mar

ried

24%

, oth

er (d

ivor

ced,

sepa

rate

d, w

idow

ed) 2

1%; l

ivin

gal

one

34%

Sim

ple

diso

rder

26%

, diff

use

diso

rder

16%

Year

s sin

ce fi

rst

ever

para

suic

ide

8.8

(SD

8.7

)T

here

wer

e no

impo

rtan

tdi

ffere

nces

in b

asel

ine

char

acte

ristic

s be

twee

ntw

o gr

oups

and

tho

sew

ith a

nd w

ithou

t 12

-mon

th a

sses

smen

t

van

den

Bosc

het

al.,

200

259D

SM-IV

dia

gnos

is fo

rBP

D S

CID

-II, s

cree

ning

devi

ce (P

DQ

-4+

).Su

bsta

nce

abus

epr

oble

ms

wer

e as

sess

edw

ith E

urop

ASI

Mea

n34

.9(1

8–70

)

FD

utch

nat

iona

lity

97%

Educ

atio

n: D

BT 1

2.6

year

s,

TAU

13.

6ye

ars

Une

mpl

oyed

: DBT

26%

, TA

U 1

6%N

ever

mar

ried:

DBT

56%

, TA

U 6

8%Li

ving

alo

ne: D

BT 3

3%,

TAU

39%

Disa

bilit

y pe

nsio

n: D

BT 5

6%,

TAU

61%

Num

ber

of B

PD c

riter

ia(m

ean)

: DBT

n=

7.3

, TA

U n

= 7

.3H

istor

y of

sui

cide

att

empt

s:D

BT n

= 7

0%,

TAU

n=

71%

Hist

ory

of s

elf-

mut

ilatio

n:D

BT n

= 9

3%,

TAU

n=

94%

Life

time

self-

mut

ilatio

n ac

ts(m

edia

n): D

BT n

= 1

3.1,

TAU

n=

14.

4A

ddic

tive

prob

lem

s:

DBT

n=

59%

, TA

U n

= 5

2%

Ave

rage

num

ber

of d

ays

inre

siden

tial t

reat

men

ts in

the

past

4 y

ears

= 7

4 da

ys p

erye

ar; a

vera

ge n

umbe

r of

adm

issio

ns in

the

pas

t4

year

s ra

nged

from

four

to

58

The

re w

as n

o sig

nific

ant

diffe

renc

e be

twee

ntr

eatm

ent

cond

ition

s on

soci

o-de

mog

raph

icva

riabl

es, n

umbe

r of

DSM

-IV c

riter

ia fo

r BP

D,

hist

ory

of s

uici

deat

tem

pts,

num

ber

of s

elf-

mut

ilatin

g ac

ts, o

rpr

eval

ence

of c

linic

ally

signi

fican

t al

coho

l and

/or

drug

use

pro

blem

s

F, fe

mal

e; m

, Mal

e.


93


TA

BLE

25

Patie

nt c

hara

cter

istic

s: n

on-R

CT

Stud

yM

etho

ds fo

r di

agno

sis

Age

Gen

der

Ethn

icit

yEd

ucat

ion/

soci

o-ec

onom

ic

Pati

ent

hist

ory

Bas

elin

e co

mpa

rabi

lity

of d

isor

der

(yea

rs)

back

grou

nd

Wilb

erg

et a

l.,19

9860

DSM

-III (

DSM

-III-R

),H

SRS,

SC

ID-I

and

SCID

-II

Trea

tmen

tgr

oup:

mea

n 27

±5

Con

trol

grou

p:m

ean

32±

9

Trea

tmen

tgr

oup:

unc

lear

,th

e te

xt s

tate

sth

at t

here

was

only

one

mal

eou

t of

12

in t

hegr

oup,

but

the

sam

ple

char

acte

ristic

sta

ble

show

sth

at 9

2% o

fth

e gr

oup

wer

em

ale

Con

trol

gro

up:

71%

M,

(22/

31)

NR

Mea

n nu

mbe

r of

mon

ths

in w

ork

in t

he la

st y

ear

befo

re a

dmiss

ion:

trea

tmen

t gr

oup

8±3

and

for

the

cont

rol g

roup

7±

5

Thr

ee o

f the

pat

ient

s in

the

trea

tmen

t gr

oup

(25%

) and

20

in t

he c

ontr

ol g

roup

(65%

) had

ever

bee

n m

arrie

d

Trea

tmen

t gr

oup:

nin

epa

tient

s ha

d pr

evio

usho

spita

lisat

ions

; nin

e ha

d a

hist

ory

of s

uici

de a

ttem

pts;

thre

e ha

d an

anx

iety

diso

rder

, eig

ht a

moo

ddi

sord

er a

nd 8

a s

ubst

ance

use

diso

rder

Con

trol

gro

up: 1

7 pa

tient

sha

d pr

evio

usho

spita

lisat

ions

; 13

had

ahi

stor

y of

sui

cide

att

empt

s;13

had

an

anxi

ety

diso

rder

,12

a m

ood

diso

rder

and

20

a su

bsta

nce

use

diso

rder

The

con

trol

gro

up w

assig

nific

antly

you

nger

tha

nth

e tr

eatm

ent

grou

p(p

<0.

001)

and

had

less

ofte

n be

en m

arrie

d(p

<0.

05).

The

tre

atm

ent

grou

p ha

d a

signi

fican

tlylo

nger

sta

y in

the

day

hosp

ital (

11 v

s 6

mon

ths,

p<

0.05

)

Appendix 3

94 TA

BLE

26

Out

com

es a

nd a

naly

sis in

form

atio

n: R

CTs

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

Bate

man

and

Fon

agy,

199

951(1

) Eng

agin

g th

e pa

tient

s in

tre

atm

ents

; (2)

red

uctio

nin

gen

eral

psy

chia

tric

sym

ptom

s; (3

) dec

reas

e in

the

num

ber

of s

elf-

dest

ruct

ive

acts

and

sui

cide

att

empt

s;(4

) im

prov

emen

t in

soc

ial a

nd in

terp

erso

nal f

unct

ions

;(5

) pre

vent

ion

of r

elia

nce

on p

rolo

nged

hos

pita

l sta

ys

(1) S

uici

de a

nd S

elf-

Har

m In

vent

ory;

(2) S

CL-

90-R

; (3)

BD

I; (4

) Spi

elbe

rgSt

ate-

Trai

t A

nxie

ty In

vent

ory;

(5

) mod

ified

SA

S; (6

) Inv

ento

ry o

fIn

terp

erso

nal P

robl

ems

Base

line,

3, 6

, 9, 1

2, 1

5an

d 18

mon

ths

No;

cro

ss-o

ver

and

drop

out

patie

nts

wer

e no

t in

clud

edin

the

ana

lyse

s

Koon

s et

al.,

200

152(1

) Whe

ther

res

earc

h th

erap

ist o

f cur

rent

stu

dy c

ould

cond

uct

DBT

with

ade

quat

e ad

here

nce;

(2) o

utco

mes

of t

he D

BT a

re s

uper

ior

to t

hose

of u

sual

car

e in

the

sam

e se

ttin

g an

d sy

stem

: par

asui

cide

, sui

cida

l ide

atio

nan

d ho

pele

ssne

ss, m

ood

and

emot

ion,

diss

ocia

tion,

psyc

hiat

ric in

patie

nt a

dmiss

ion,

BPD

crit

eria

(1) P

HI;

(2) B

eck

Scal

e fo

r Su

icid

eId

eatio

n; (3

) BH

S; (4

) BD

I; (5

) HA

M-

D; (

6) H

ARS

; (7)

Spi

elbe

rg A

nger

Expr

essio

n Sc

ale;

(8) D

ES

Pret

reat

men

t, 3

and

6m

onth

sN

o

Line

han

et a

l., 1

99153

(1) P

aras

uici

de; (

2) m

aint

enan

ce in

the

the

rapy

; (3

) psy

chia

tric

inpa

tient

tre

atm

ent

(1) P

HI;

(2) s

elf-

repo

rt fo

rm o

f the

Scal

e fo

r Su

icid

e Id

eato

rs; (

3) B

DI;

(4) B

HS;

(5) R

easo

ns fo

r Li

ving

Inve

ntor

y, S

urvi

val a

nd C

opin

g Sc

ale

Pret

reat

men

t, 4,

8 a

nd

12 m

onth

sN

o

Line

han

et a

l., 1

99954

(1) A

dapt

atio

n of

the

orig

inal

DBT

man

ual f

or a

popu

latio

n of

sub

stan

ce-a

busin

g w

omen

with

BPD

;(2

) com

paris

on o

f its

effi

cacy

to

a co

ntro

l (TA

U)

cond

ition

: dru

g ab

use;

tre

atm

ent

initi

atio

n, e

xpos

ure

and

rete

ntio

n; p

sych

opat

holo

gy

(1) S

truc

ture

d cl

inic

al in

terv

iew

s;

(2) u

rine

anal

yses

; (3)

tre

atm

ent

hist

ory

inte

rvie

w; (

4) P

HI;

(5) S

HI;

(6) S

AS;

(7) L

ongi

tudi

nal I

nter

view

Follo

w-U

p Ev

alua

tion

base

sch

edul

e;(8

) GSA

; (9)

GA

S; (1

0) S

piel

berg

Stat

e–Tr

ait

Ang

er E

xpre

ssio

nIn

vent

ory

Pret

reat

men

t, 4,

8, 1

2 an

d 16

mon

ths

Yes

Line

han

et a

l., 2

00255

(1) D

ecre

ase

in o

piat

e de

pend

ence

; (2)

dec

reas

e in

BPD

sym

ptom

s: t

reat

men

t in

itiat

ion,

exp

osur

e an

dre

tent

ion;

dru

g us

e ou

tcom

es; p

sych

opat

holo

gy

(1) U

rine

anal

yses

Inte

rvie

w a

nd s

elf-

repo

rt m

easu

res:

(2) T

LFB;

(3) P

HI;

(4) S

HI;

(5) S

AS;

(6) L

ongi

tudi

nal I

nter

view

Fol

low

-up

Eval

uatio

n; (7

) GA

S; (8

) GSA

; (9

) GA

F; (1

0) B

SI

Pret

reat

men

t, 4,

8, 1

2an

d 16

mon

ths

Yes

cont

inue

d


95


TA

BLE

26

Out

com

es a

nd a

naly

sis in

form

atio

n: R

CTs

(con

t’d)

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

Mun

roe-

Blum

and

Mar

zial

i,19

9556

(1) B

ehav

iour

s re

late

d to

soc

ial d

ysfu

nctio

n;

(2) b

ehav

iour

s re

late

d to

soc

ial p

erfo

rman

ce;

(3) s

ympt

om s

tatu

s

(1) O

BI; (

2) S

AS;

(3) B

DI;

(4) H

SC-9

0Ba

selin

e, 6

, 12,

18

and

24m

onth

sN

o

TA

BLE

27

Out

com

es a

nd a

naly

sis in

form

atio

n: n

on-R

CTs

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

Wilb

erg

et a

l., 1

99860

GSI

, Glo

bal S

ympt

om In

dex.

Redu

ctio

n of

sub

stan

ce m

isuse

, sui

cide

att

empt

s,m

enta

l sta

teH

SRS,

GSI

At

adm

issio

n, d

ischa

rge

and

follo

w-u

pN

o

Turn

er, 2

00057

(1) S

uici

de/s

elf-

harm

ing

beha

viou

r; (2

) em

otio

nal

dysr

egul

atio

n; (3

) im

pact

of t

reat

men

t in

dica

tors

; (4

) hos

pita

lisat

ion

(1) H

AM

-D; (

2) B

PRS;

(3) T

arge

tBe

havi

our

Ratin

gs; (

4) B

DI;

(5) B

AI;

(6) B

eck

Scal

e fo

r Su

icid

e Id

eatio

n

Pret

reat

men

t, 6

and

12m

onth

sYe

s

Tyre

r et

al.,

200

358(1

) Par

asui

cide

eve

nts

(incl

udin

g su

icid

e) in

the

follo

win

g ye

ar; (

2) u

ptak

e of

MA

CT

ses

sions

; (3

) sym

ptom

impr

ovem

ents

(DSH

, anx

iety

,de

pres

sion

and

soci

al fu

nctio

ning

) at

1 ye

ar; (

4) O

ther

outc

omes

(1) H

AD

S; (2

) GA

F; (3

) SFQ

; (4)

EQ

-5D

; (5)

CSR

I; (6

) PH

IBa

selin

e, 6

and

12m

onth

sYe

s

van

den

Bosc

h et

al.,

200

259(1

) Tre

atm

ent

rete

ntio

n; (2

) hig

h-ris

k be

havi

our,

incl

udin

g su

icid

al, s

elf-

mut

ilatin

g an

d se

lf-da

mag

ing

impu

lsive

beh

avio

urs;

(3) w

heth

er t

he e

ffica

cy o

f DBT

is m

odifi

ed b

y ba

selin

e se

verit

y of

par

asui

cide

(1) B

PDSI

(sem

i-str

uctu

red

inte

rvie

w).

BPD

SI c

onsis

ts o

f nin

ese

ctio

ns, o

ne fo

r ea

ch o

f the

DSM

-IVcr

iteria

for

BPD

. The

par

asui

cide

sect

ion

incl

udes

thr

ee it

ems;

the

impu

lsive

sec

tion

incl

udes

11

item

s;(2

) LPC

Base

line,

11,

12,

33,

44

and

52 w

eeks

; 18

mon

ths

follo

w-u

p

Yes

Appendix 3

96 TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Bate

man

and

Fon

agy,

1999

51(1

) Spi

elbe

rg In

vent

ory

scor

e

Base

line

End-

poin

t (1

8 m

onth

s)Fo

llow

-up

(36

mon

ths)

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

Stat

ePH

68.4

7.0

–52

.5

11.5

51.3

32.6

5.9

32.3

TAU

63.2

6.8

–65

.59.

366

.652

.410

.352

.9

Trai

tPH

66.5

6.1

–56

.89.

155

.234

.46.

134

.1TA

U62

.09.

9–

61.0

7.6

36.0

42.7

10.1

43.4

(2) B

eck

Dep

ress

ion

Scal

e Base

line

End-

poin

t (1

8 m

onth

s)Fo

llow

-up

(36

mon

ths)

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

PH36

.07.

6–

20.6

7.0

20.3

11.9

3.3

11.9

TAU

34.9

7.4

–35

.27.

435

.720

.410

.520

.6

(3) G

loba

l Sev

erity

Inde

x sc

ore

Base

line

End-

poin

t (1

8mon

ths)

Follo

w-u

p (3

6 m

onth

s)

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

PH2.

500.

58–

2.10

0.82

2.1

0.8

0.6

0.8

TAU

2.30

0.71

–2.

400.

702.

42.

00.

52.

0

(4) P

ositi

ve S

ympt

om t

otal

sco

re

Base

line

End-

poin

t (1

8 m

onth

s)Fo

llow

-up

(36

mon

ths)

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

Mea

nSD

Adj

uste

d m

ean

PH74

.114

.5–

70.7

17.3

72.0

40.6

19.6

40.2

TAU

72.3

15.2

–73

.115

.073

.574

.59.

675

.3

(5) I

n th

e PH

gro

up, t

here

was

a cl

ear

redu

ctio

n of

sui

cide

atte

mpt

s fr

om 9

4.7%

on

adm

issio

n to

5.3

%

(mea

n 0.

16) a

t 18

mon

ths.

Thi

s tr

end

was

hig

hly

signi

fican

t (K

enda

ll’s

W=

0.59

,�

2=

33.5

, df=

3, p

<0.

001)

.N

o sig

nific

ant

tren

d fo

r th

eco

ntro

l gro

up (K

enda

ll’s

W=

0.04

, �2

=2.

4, d

f=3,

ns).

Gro

up d

iffer

ence

s em

erge

d by

6 m

onth

s. T

he n

umbe

r of

indi

vidu

als

who

wer

e no

long

erpa

rasu

icid

al w

as s

igni

fican

tlygr

eate

r in

the

PH

gro

up t

han

inth

e TA

U g

roup

by

12 m

onth

s(�

2=

4.3,

df =

1, p

<0.

05)


97


TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Koon

s et

al.,

200

152Pr

eM

idPo

stPr

e–m

idPr

e–po

stPr

e vs

Pos

t G

roup

×F

Fef

fect

siz

eaT

ime

F 2,3

6

Mea

nSD

Mea

nSD

Mea

nSD

Para

suic

ides

pas

t 3

mon

ths

DBT

5.1

13.2

1.6

3.7

0.4

1.3

2.5

4.75

†0.

352.

44†

TAU

0.7

1.3

1.1

2.3

12.

20.

030.

010.

28Su

icid

al id

eatio

nD

BT36

.213

.534

.913

.526

.28

0.89

9.64

*0.

983.

71*

TAU

44.6

11.4

41.9

13.3

41.5

14.3

1.61

2.89

0.54

Hop

eles

snes

sD

BT11

.96.

70.

47.

55.

15.

31.

6317

.08*

*1.

318.

03**

TAU

13.6

6.8

127.

814

.27.

31.

250.

3–0

.18

Ham

ilton

Dep

ress

ion

DBT

29.7

13.7

24.7

10.1

17.1

5.7

4.67

†12

.40*

*1.

120.

71TA

U32

.69.

731

.111

.324

.37.

80.

889.

09*

0.95

Beck

Dep

ress

ion

DBT

22.8

11.1

21.3

13.4

13.4

7.5

0.25

9.35

*0.

963.

70*

TAU

34.7

14.6

2714

.629

.317

.725

.40*

*5.

93*

0.77

Ham

ilton

Anx

iety

DBT

18.4

7.3

18.1

8.4

19.1

7.5

0.02

0.13

–0.3

11.

32TA

U27

.79.

325

.810

.732

.212

.41.

071.

79–0

.42

Ang

er in

DBT

22.9

5.7

19.3

5.4

17.3

46.

19*

11**

1.04

1.71

TAU

20.5

4.7

18.2

5.4

19.2

6.2

6.99

**0.

310.

17A

nger

out

DBT

18.2

5.7

17.3

4.8

14.5

3.9

0.67

13.3

8**

1.16

5.89

**TA

U17

.25.

814

.63.

117

.96.

13.

160.

16–0

.12

Diss

ocia

tion

DBT

22.3

15.2

2016

.213

.212

0.79

13**

1.13

1.21

TAU

4122

.429

.522

.530

.623

.33.

052.

40.

48BP

D c

riter

iaD

BT6.

81.

13.

61.

679

.45*

*2.

830.

79b

TAU

6.7

0.8

4.2

2.3

12.6

4**

1.13

† p <

0.1

; *p

< 0

.05;

**p

< 0

.01.

aEf

fect

siz

e co

mpu

ted

as (m

ean

pre-

mea

n po

st) (

SD p

re-p

ost)

.b

BPD

crit

eria

wer

e as

sess

ed o

nly

at p

retr

eatm

ent

and

post

trea

tmen

t. D

egre

es o

f fre

edom

for

Fte

st a

re (1

,18)

.

The

pro

port

ion

of p

atie

nts

with

any

adm

issio

ns d

urin

g th

epr

ior

3 m

onth

s w

as r

elat

ivel

ylo

w a

t pr

etre

atm

ent,

and

neith

er g

roup

sho

wed

signi

fican

t ch

ange

in t

his

prop

ortio

n by

the

end

of

trea

tmen

t

Appendix 3

98 TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Line

han

et a

l., 1

99153

(1) P

aras

uici

deLi

kelih

ood

of a

ny p

aras

uici

de:

DBT

63.

6%, T

AU

95.

5%, z

2.26

, p <

0.0

05

Med

ical

risk

sco

res:

DBT

mea

n 9.

21, S

D 8

.22,

n =

14

TAU

mea

n 17

.86,

SD

20.

94, n

= 2

1(t

= 1

.70,

df =

28.

01, p

< 0

.05)

Part

icip

ants

who

rec

eive

d D

BT h

ad a

med

ian

of 1

.5 p

aras

uici

de a

cts

per

year

com

pare

d w

ith n

ine

acts

per

yea

r fo

rco

ntro

l par

ticip

ants

(2) M

aint

enan

ce in

the

rapy

DBT

pat

ient

s w

ere

signi

fican

tly m

ore

likel

y to

sta

rt in

divi

dual

the

rapy

tha

n w

ere

cont

rol p

artic

ipan

ts, a

ll of

who

m w

ere

refe

rred

for

trea

tmen

t (1

00%

and

73%

for

part

icip

ants

ass

igne

d to

DBT

and

con

trol

par

ticip

ants

, res

pect

ivel

y, z

= 2

.75,

p <

0.0

03)

(3) P

sych

iatr

ic in

patie

nt t

reat

men

tN

umbe

r of

hos

pita

lised

par

ticip

ants

DBT

(n)

Con

trol

(n)

zp

0–4

mon

ths

69

2.54

<0.

005

4–8

mon

ths

57

8–12

mon

ths

37

1.49

<0.

10Ye

ar8

121.

70<

0.05

(4) T

hrou

ghou

t th

e fo

llow

-up

year

, bot

h th

e pa

rasu

icid

ere

peat

rat

e (D

BT 2

6%,

TAU

60%

, z =

2.1

2, p

< 0

.01)

and

the

likel

ihoo

d of

any

psyc

hiat

ric h

ospi

talis

atio

n(D

BT 1

1%, T

AU

40%

, z

= 1

.43,

p <

0.0

7) w

ere

low

er fo

r pa

rtic

ipan

tsco

mpl

etin

g D

BT t

han

for

part

icip

ants

rem

aini

ng in

TA

U

(5) P

sych

iatr

ic in

patie

nt d

ays

durin

g th

e 18

–24-

mon

thpe

riod

wer

e lo

wer

for

part

icip

ants

com

plet

ing

trea

tmen

t

(6) A

t th

e en

d of

the

24-

mon

thtim

e-po

int,

part

icip

ants

com

plet

ing

DBT

wer

e ra

ted

signi

fican

tly h

ighe

r on

ove

rall

soci

al a

djus

tmen

t by

the

inte

rvie

wer


99


TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Line

han

et a

l., 1

99954

(1) D

rug

abus

e (IT

T a

naly

ses,

n =

28)

DBT

TAU

Mea

nSD

Mea

nSD

F-va

lue

Effe

ct s

ize

(p-v

alue

)

Pret

reat

men

t as

sess

men

t0.

360.

260.

220.

28

Pret

reat

men

t to

4 m

onth

s0.

630.

340.

320.

373.

160.

80(p

< 0

.05)

4–8

mon

ths

0.62

0.35

0.38

0.34

1.50

0.65

8–12

mon

ths

0.67

0.38

1.39

0.44

1.67

0.64

(n=

8)

Year

tot

al0.

630.

330.

350.

342.

830.

93(n

= 1

0)(p

< 0

.05)

12–1

6 m

onth

s0.

940.

170.

580.

364.

040.

59(p

< 0

.05)

(2) T

reat

men

t in

itiat

ion,

exp

osur

e an

d re

tent

ion:

DBT

mea

n 43

.14±

10.6

7; T

AU

mea

n 31

.6±

27.8

8, F

1,15

= 1

.07,

ns

Whe

n ca

se m

anag

emen

t ho

urs

are

excl

uded

from

the

se a

naly

ses,

DBT

par

ticip

ants

rec

eive

sig

nific

antly

mor

eps

ycho

ther

apy

than

do

TAU

par

ticip

ants

D

BT: m

ean

43.1

4±10

.67;

TA

U: m

ean

21.8

8±32

.32,

F1,

15=

2.0

7, p

< 0

.05.

TA

U p

artic

ipan

ts r

arel

y pa

rtic

ipat

ed in

gro

upps

ycho

ther

apy

(3) P

artic

ipan

ts a

s a

grou

p sh

owed

sig

nific

ant

redu

ctio

ns o

ver

time

on fr

eque

ncy

of p

aras

uici

de e

piso

des

and

stat

e an

dtr

ait

ange

r

(4) P

sych

opat

holo

gy. T

here

wer

e no

bet

wee

n-gr

oup

diffe

renc

es o

n ot

her

outc

ome

mea

sure

s (e

.g. p

aras

uici

deep

isode

s, G

SA, G

AS

or a

nger

)du

ring

trea

tmen

t or

at

the

12-m

onth

pos

t-tr

eatm

ent

follo

w-u

p

At

the

16-m

onth

follo

w-u

pas

sess

men

t D

BT p

artic

ipan

tssh

owed

bet

ter

soci

al a

ndgl

obal

adj

ustm

ent,

with

signi

fican

tly lo

wer

(bet

ter)

scor

es o

n th

e G

SA:

DBT

: mea

n 2.

25±

0.75

; TA

U:

mea

n 2.

92±

0.71

, F1,

12=

3.9

8,p

<0.

05 fo

r be

st w

eek

scor

es

DBT

: mea

n 3.

04±

0.89

; TA

U: m

ean

3.74

±0.

67,

F 1,1

2=

2.94

, p=

0.0

56 fo

r la

stm

onth

sco

res

and

high

ersc

ores

on

the

GA

S

DBT

: mea

n 69

±12

; TA

U: m

ean

49±

10,

F 1,1

2=

22.2

4, p

<0.

001

for

best

wee

k sc

ores

DBT

: mea

n 62

±10

; TA

U: m

ean

44±

10,

F 1,1

2=

22.

19, p

< 0

.001

for

last

wee

k sc

ores

Appendix 3

100 TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Line

han

et a

l., 2

00255

(1) T

reat

men

t in

itiat

ion,

exp

osur

e an

d re

tent

ion.

DBT

CVT

+12

S

Year

tot

alM

ean

SDM

ean

SDt 2

1p

Mea

n nu

mbe

r of

indi

vidu

al s

essio

ns r

ecei

ved

33.2

20.4

33.0

9.6

2.62

<0.

05N

umbe

r of

ski

lls g

roup

ses

sions

26.6

15.9

10.8

12.8

(2) U

rinan

alys

isBy

wee

k 52

(end

of 1

2 m

onth

s); D

BT p

artic

ipan

ts h

ad a

sig

nific

antly

low

er p

erce

ntag

e of

opi

ate-

posit

ive

urin

anal

yses

tha

nC

VT+

12S

part

icip

ants

(t =

2.3

2, p

< 0

.02)

At

16 m

onth

s pe

rcen

tage

of p

ositi

ve u

rinan

alys

es in

bot

h co

nditi

ons:

DBT

27%

, CVT

+12

S 33

%

(3) S

elf-

repo

rt

Year

tot

alD

BTC

VT+

12S

Mea

n (%

)SD

Mea

n (%

)SD

Self-

repo

rtH

eroi

n66

.26

67.0

191

.14

91.8

6C

ocai

ne83

.12

80.9

378

.90

72.0

8A

mph

etam

ines

99.9

799

.92

100.

0010

0.00

Barb

itura

tes

99.9

799

.92

99.9

299

.84

Seda

tives

99.8

299

.39

99.8

399

.48

Uri

nana

lyse

sH

eroi

n46

.43

68.3

453

.30

83.4

0C

ocai

ne70

.86

80.6

672

.27

78.5

8A

mph

etam

ines

88.0

789

.87

91.7

288

.68

Barb

itura

tes

88.4

690

.11

92.4

588

.14

Seda

tives

86.3

689

.24

90.9

288

.22

(4) P

sych

opat

holo

gyin

bot

h gr

oups

:

Pret

reat

men

t12

mon

ths

Mea

nSD

Mea

nSD

Zp

BSI

1.78

711.

170.

603.

17<

0.00

2BS

I (16

-mon

th fo

llow

-up)

GA

S37

.65.

647

.410

.73.

59<

0.00

1

BSI (

16-m

onth

follo

w-u

p): z

= 1

.76,

p <

0.0

8, m

ean

0.98

±0.

74).

(5) G

loba

l adj

ustm

ent

impr

ovem

ents

wer

em

aint

aine

d, b

ut d

id n

otim

prov

e fu

rthe

r. T

he in

cide

nts

of p

aras

uici

dal b

ehav

iour

and

psyc

hiat

ric o

r dr

ug-r

elat

edvi

sits

to e

mer

genc

y ro

oms

and

inpa

tient

uni

ts w

ere

low

, but

ther

e w

ere

no s

igni

fican

tbe

twee

n-co

nditi

on d

iffer

ence

s


101


TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Mun

roe-

Blum

and

Mar

zial

i, 19

9556

The

re w

ere

no s

igni

fican

t fin

ding

s w

ith r

espe

ct t

o th

e m

ajor

out

com

e va

riabl

es u

nder

stu

dy; h

owev

er, b

oth

trea

tmen

tsdi

d ex

perie

nce

signi

fican

t im

prov

emen

ts o

ver

time

refle

cted

on

beha

viou

ral i

ndic

ator

s, s

ocia

l adj

ustm

ent,

glob

alsy

mpt

oms

and

depr

essio

n

Coh

ort

anal

ysis

of v

aria

nce

Scal

e m

eans

(SD

) at

thre

e po

ints

in t

ime

OBI

SAS

HSC

-90

BDI

Pret

reat

men

t32

.01

(10.

88)

2.13

(0.4

2)1.

76 (0

.68)

25.9

(9.8

9)12

mon

ths

30.9

9 (1

2.67

)1.

91 (0

.50)

1.26

(0.6

9)18

.4 (1

2.46

)24

mon

ths

23.6

1 (1

0.58

)1.

89 (0

.59)

1.03

(0.7

8)14

.6 (1

2.29

)na

4843

4546

F 2.9

4=

10F 2

.84

= 7

F 2.8

8=

16

F 2.9

0=

17

0.76

b0.

040.

420.

93

a N

umbe

rs v

ary

beca

use

of m

issin

g da

ta.

b p

= 0

.000

1.

The

re w

ere

no s

igni

fican

tdi

ffere

nces

in o

utco

me

betw

een

the

two

trea

tmen

t-tim

e ex

posu

re g

roup

s; t

he lo

wex

posu

re g

roup

mad

e ga

ins

com

para

ble

to t

hose

of t

hehi

gh e

xpos

ure

grou

p on

all

ofth

e ou

tcom

e m

easu

res

Turn

er, 2

00057

(1) M

easu

res

CC

T (n

= 1

2)D

BT (n

= 1

2)

Pret

reat

men

t6

mon

ths

12 m

onth

sPr

etre

atm

ent

6 m

onth

s12

mon

ths

Ratin

g of

par

asui

cide

7.25

(0.7

5)4.

33 (1

.92)

4.25

(2.1

8)7.

17 (0

.83)

2.08

(2.0

2)1.

50 (1

.98)

Beck

Sui

cide

Idea

tion

Scal

e23

.53

(3.3

4)13

.33

(9.7

9)11

.58

(9.2

1)24

.08

(3.7

3)2.

83 (3

.49)

3.83

(8.0

3)N

umbe

r of

sui

cide

/13

.58

(3.3

4)6.

75 (5

.97)

5.58

(5.2

8)14

.08

(3.7

3)2.

17 (1

.95)

0.75

(1.2

3)se

lf-ha

rm a

ttem

pts

Ratin

g of

impu

lsive

ness

7.58

(0.5

1)6.

67 (0

.78)

6.08

(1.0

8)7.

42 (0

.51)

5.83

(0.8

3)4.

58 (1

.62)

Ratin

g of

ang

er7.

08 (0

.90)

5.92

(0.7

9)5.

67 (1

.15)

7.33

(0.6

5)5.

00 (1

.21)

4.67

(1.3

0)BD

I27

.75

(6.1

1)24

.75

(4.9

4)24

.08

(5.5

5)27

.58

(5.3

0)18

.08

(7.9

1)14

.92

(8.2

6)H

AM

-D17

.42

(4.4

6)13

.67

(2.9

3)12

.58

(3.9

0)20

.75

(4.3

3)8.

58 (6

.58)

7.50

(5.9

6)BA

I20

.42

(3.4

5)17

.08

(5.8

2)14

.83

(6.3

4)19

.25

(3.5

5)12

.58

(4.8

9)10

.17

(6.5

3)BP

RS30

.83

(6.0

0)25

.83

(8.4

0)25

.33

(3.9

4)30

.33

(6.5

6)18

.42

(7.3

3)18

.17

(7.9

0)H

ospi

talis

atio

n da

ys10

.00

(8.1

1)10

.75

(16.

27)

13.0

0 (1

5.34

)10

.20

(3.3

7)2.

67 (6

.58)

0.75

(1.9

6)

(2) A

sses

smen

t of

tre

atm

ent

cred

ibili

ty

The

ana

lysis

foun

d no

signi

fican

t di

ffere

nce

betw

een

trea

tmen

ts r

egar

ding

cred

ibili

ty, (

t 22

= 1

.63,

p

= 0

.116

)

(3) A

sses

smen

t of

hel

ping

allia

nce

diffe

renc

es

Hel

ping

Rel

atio

nshi

pQ

uest

ionn

aire

(HRQ

) sho

wed

no s

igni

fican

t di

ffere

nce

betw

een

trea

tmen

ts

(F1,

16=

1.1

0, p

= 0

.31)

Appendix 3

102 TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Tyre

r et

al.,

200

358Re

sults

rel

ated

to

BPD

are

onl

y re

port

ed w

here

it is

pos

sible

to

diffe

rent

iate

(1) P

ropo

rtio

ns o

f tot

al 4

30 p

atie

nts

expe

rienc

ing

a re

peat

sel

f-ha

rm (p

aras

uici

de) e

piso

de o

ver

1ye

ar, i

ncid

ence

rat

e an

dfr

eque

ncy

of s

elf-

harm

epi

sode

s in

tho

se s

epar

ated

by

cate

gory

of P

D (I

CD

-10

cate

gorie

s)

Para

suic

ide

even

ts d

urin

g fo

llow

-up

BPD

PD

Diff

use

No

PD(n

= 6

7)(n

= 1

17)

(n=

69)

(n=

39)

Non

e30

(44.

8%)

57 (4

8.7%

)31

(44.

9%)

31 (7

9.5%

)A

t le

ast

one

37 (5

5.2%

)60

(51.

3%)

38 (5

5.1%

)8

(20.

5%)

Sam

ple

sizea

(n=

60)

Inci

denc

e ra

tea

Firs

t ep

isode

per

per

son-

year

follo

w-u

p0.

762

0.63

40.

659

0.22

925

th p

erce

ntile

tim

e to

par

asui

cide

eve

nt (d

ays)

a89

132

162

Freq

uenc

y of

sel

f-ha

rm (p

er y

ear)

3.15

aT

hese

figu

res

refe

r to

the

orig

inal

400

pat

ient

s fo

r w

hom

det

aile

d in

form

atio

n on

firs

t se

lf-ha

rm w

as a

vaila

ble.

(2) P

ropo

rtio

n of

430

pat

ient

s ex

perie

ncin

g a

repe

at s

elf-

harm

(par

asui

cide

) epi

sode

ove

r 1

year

MA

CT

(PD

)TA

U (P

D)

Para

suic

ide

even

ts d

urin

g fo

llow

-up

0–6

mon

ths

6–12

mon

ths

0–6

mon

ths

6–12

mon

ths

(n=

91)

(n=

88)

(n=

90)

(n=

83)

Inci

denc

e ra

tea

Non

e57

(62.

2%)

55 (6

2.5%

)49

(54.

4%)

61(7

3.5%

)A

t le

ast

one

34 (3

7.4%

)33

(37.

5%)

41 (4

5.6%

)22

(26.

5%)

Firs

t ep

isode

per

per

son-

year

follo

w-u

p0.

584

0.71

25th

per

cent

ile t

ime

to p

aras

uici

de e

vent

(day

s)a

212

89Fr

eque

ncy

of s

elf-

harm

(per

6-m

onth

per

iod)

1.65

1.18

3.74

(1.6

3b )3.

61 (0

.88b )

Freq

uenc

y of

sel

f-ha

rm (p

er y

ear)

2.84

7.36

(2.5

4b )

a T

hese

figu

res

refe

r to

the

orig

inal

400

pat

ient

s fo

r w

hom

det

aile

d in

form

atio

n on

firs

t se

lf-ha

rm w

as a

vaila

ble.

b Ex

clud

ing

patie

nts

with

420

epi

sode

s.

(3) T

he p

sych

omet

ricas

sess

men

t ou

tcom

es s

how

edno

diff

eren

ce b

etw

een

MA

CT

and

TAU


103


TA

BLE

28

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

van

den

Bosc

h et

al.,

2002

59

(Ver

haul

et

al.,

2003

64)

(1) T

reat

men

t re

tent

ion

Sign

ifica

ntly

mor

e pa

tient

s w

ho w

ere

rece

ivin

g D

BT (n

= 1

7; 6

3%) t

han

patie

nts

in t

he c

ontr

ol g

roup

(n =

7; 2

3%)

cont

inue

d in

the

rapy

with

the

sam

e th

erap

ist fo

r th

e en

tire

year

(�2 1

= 9

.70,

p =

0.0

02)

(2) H

igh-

risk

beha

viou

rsT

he fr

eque

ncy

and

cour

se o

f sui

cida

l beh

avio

urs

wer

e no

t sig

nific

antly

diff

eren

t ac

ross

tre

atm

ent

grou

ps (t

1,13

7=

0.0

3,p

=0.

866)

and

the

inte

ract

ion

betw

een

time

and

trea

tmen

t co

nditi

on (t

1,16

6=

0.2

2, p

= 0

.639

) did

not

rea

ch s

tatis

tical

signi

fican

ceSe

lf-m

utila

ting

beha

viou

rs in

DBT

pat

ient

s gr

adua

lly d

imin

ished

ove

r th

e tr

eatm

ent

year

, whe

reas

pat

ient

s in

TA

U g

roup

grad

ually

det

erio

rate

d: a

sig

nific

ant

effe

ct w

as T

ime

x Tr

eatm

ent

cond

ition

(t1,

44.4

= 1

0.24

, p =

0.0

03),

but

not

for

trea

tmen

t co

nditi

on a

lone

(t1,

69.1

= 3

.80;

p=

0.0

55).

The

mos

t co

mm

on s

elf-

mut

ilatin

g ac

ts w

ere

cutt

ing,

bur

ning

,pr

icki

ng a

nd h

ead

bang

ing

(3) I

mpa

ct o

f DBT

on

seve

rity

of s

ubst

ance

use

pro

blem

s at

18-

mon

th fo

llow

-up

Euro

pASI

item

(a)

DBT

, mea

n±SD

TAU

, mea

n±SD

Com

paris

on a

t 18

-mon

th fo

llow

-up

corr

ecte

d fo

r ba

selin

eb

Base

line

Follo

w-u

paBa

selin

eFo

llow

-upa

Fp

(n=

27)

(n =

20)

(n =

31)

(n =

24)

Day

s ≥

5 dr

inks

pas

t 7.

1±10

.36.

1±9.

86.

2±9.

23.

8±7.

80.

90.

34m

onth

s 0–

30

Day

s m

edic

atio

n us

e pa

st

14.2

±14

.07.

9±12

.213

.5±

14.5

11.5

±13

.90.

40.

54m

onth

s 0–

30

Day

s ca

nnab

is us

e pa

st

6.5±

11.2

9.2±

13.3

2.3±

5.8

5.9±

11.5

0.1

0.73

mon

ths

0–30

Day

s al

coho

l pro

blem

s pa

st

8.7±

12.3

7.0±

11.3

9.0±

12.9

6.7±

11.3

00.

89m

onth

s 0–

30

Day

s dr

ug p

robl

ems

past

8.

1±11

.49.

5±13

.29.

0±12

.64.

5±10

.02

0.17

mon

ths

0–30

Seve

rity

of a

lcoh

ol

2.7±

2.3

2.8±

2.6

3.0±

2.5

2.4±

2.1

1.1

0.31

prob

lem

s 0–

9

Seve

rity

of d

rug

prob

lem

s 0–

93.

3±2.

02.

8±2.

23.

6±2.

32.

3±1.

80.

50.

47a

Follo

w-u

p sc

ores

at

18 m

onth

s sin

ce s

tart

of t

reat

men

t.b

Usin

g th

e G

ener

al L

inea

r M

odel

Mod

ule

of S

PSS

8.0,

with

Eur

opA

SI s

core

s at

18-

mon

th fo

llow

-up

as d

epen

dent

varia

bles

, tre

atm

ent

cond

ition

as

fixed

fact

or a

nd b

asel

ine

scor

es o

n Eu

ropA

SI a

s co

varia

tes.

(4) I

mpa

ct o

f bas

elin

e se

verit

yon

effe

ctiv

enes

sFo

r su

icid

al b

ehav

iour

an

alm

ost

signi

fican

t ef

fect

was

evid

ent

for

the

thre

e-w

ayin

tera

ctio

n te

rm T

ime

xTr

eatm

ent

x C

ondi

tion

(t1,

170

= 4

.81,

p=

0.0

29),

indi

catin

g a

tren

d to

war

dsgr

eate

r ef

fect

iven

ess

of D

BT in

seve

rely

affe

cted

indi

vidu

als.

For

self-

mut

ilatin

g be

havi

ours

asig

nific

ant

effe

ct w

as e

vide

ntfo

r th

e 3-

way

inte

ract

ion

term

Tim

e ×

Seve

rity

×Tr

eatm

ent

cond

ition

(t1,

404

= 1

6.82

,p

=0.

000)

and

the

inte

ract

ion

term

Sev

erity

×Tr

eatm

ent

cond

ition

(t1,

67.6

= 9

.63,

p=

0.00

3), i

ndic

atin

g th

atD

BT w

as s

uper

ior

to T

AU

inth

e hi

gh-s

ever

ity g

roup

, but

not

for

thei

r lo

wer

sev

erity

coun

terp

arts

. No

diffe

rent

ial

effe

ctiv

enes

s w

as fo

und

for

self-

dam

agin

g im

pulsi

vity

Appendix 3

104 TA

BLE

29

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): no

n-RC

Ts

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Wilb

erg

et a

l., 1

99860

(1) S

tatu

s di

men

sions

at

adm

issio

n, d

ischa

rge

and

follo

w-u

p

Tota

l sam

ple

(n=

43)

Trea

tmen

t gr

oup

(n=

12)

Con

trol

gro

up (n

= 3

1)

HSR

S ad

miss

ion

38.6

±5.

136

.9±

5.1

39.2

±5.

1H

SRS

disc

harg

e43

.5±

7.8

47.3

±5.

442

.0±

8.1*

HSR

S fo

llow

-up

51.2

±11

.957

.4±

9.0

48.8

±12

.1*

GSI

adm

issio

n1.

84±

0.55

(n =

42)

1.67

±0.

481.

92±

0.56

(n =

30)

GSI

disc

harg

e1.

28±

0.65

(n =

35)

1.11

±0.

491.

37±

0.72

(n =

23)

GSI

follo

w-u

p1.

37±

0.67

(n =

36)

1.02

±0.

501.

55±

0.67

(n =

24)

*Re

hosp

italis

atio

n13

(33%

) (n

= 4

0)1

(8%

)12

(43%

) (n

= 2

8)Su

icid

e at

tem

pts

6 (1

5%) (

n =

44)

1 (8

%)

5 (1

8%) (

n =

28)

Rem

issio

n fr

om s

ubst

ance

use

diso

rder

13/2

5 (5

2%)

6/8

(75%

)7/

17 (4

1%)

*p <

0.0

5 (t

-tes

t, tw

o-ta

iled)

(2) M

ultip

le r

egre

ssio

n m

odel

s fo

r H

SRS

at fo

llow

-up

(95%

CI)

Inde

pend

ent

varia

ble

BSE

B�

Min

.M

ax.

Sign

ifica

nce

HSR

S at

adm

issio

n0.

638

0.32

60.

274

–0.0

231.

298

0.05

8C

ontin

uous

tre

atm

ent

0.19

60.

010

0.26

6–0

.006

0.39

80.

057

Wor

k be

fore

adm

issio

n0.

899

0.32

70.

365

0.23

81.

561

0.00

9O

utpa

tient

gro

up t

hera

py7.

537

3.46

40.

288

0.52

414

.549

0.03

6

R2=

0.3

9, F

= 6

.15,

sig

nific

ance

F =

0.0

006

(3) M

ultip

le r

egre

ssio

n m

odel

s fo

r G

SI a

t fo

llow

-up

(95%

CI)

Inde

pend

ent

varia

ble

BSE

B�

Min

.M

ax.

Sign

ifica

nce

GSI

at

adm

issio

n0.

162

0.17

80.

140

–0.2

010.

525

0.37

0C

ontin

uous

tre

atm

ent

0.00

60.

007

0.14

2–0

.008

0.02

10.

362

% o

f fol

low

-up

perio

d on

med

icat

ion

0.00

50.

003

0.32

00.

0002

0.01

00.

041

Out

patie

nt g

roup

the

rapy

–0.5

520.

214

–0.4

10–0

.989

–0.1

150.

015

R2=

0.3

5, F

= 4

.08,

sig

nific

ance

F=

0.0

09


105


TA

BLE

30

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: R

CTs

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d C

oncl

usio

nsac

cept

abili

ty o

f tre

atm

ent

Bate

man

and

Fon

agy,

199

951N

RPa

tient

s tr

eate

d w

ith P

H fo

r 18

mon

ths

show

ed s

igni

fican

t im

prov

emen

t on

bot

h sy

mpt

omat

ic a

ndcl

inic

al m

easu

res.

Tre

atm

ent

was

effe

ctiv

e fo

r bo

th m

en a

nd w

omen

Koon

s et

al.,

200

152N

RT

his

stud

y de

mon

stra

tes

that

DBT

can

be

cond

ucte

d w

ith r

easo

nabl

y go

od a

dher

ence

by

a gr

oup

of t

hera

pist

s at

a s

ite in

depe

nden

t of

the

tre

atm

ent’s

dev

elop

er. T

he t

reat

men

t w

as a

ssoc

iate

dw

ith c

linic

ally

sig

nific

ant

chan

ges

in t

he s

ympt

oms

and

func

tions

of b

orde

rline

pat

ient

s, c

hang

esth

at w

ere

signi

fican

tly g

reat

er t

han

thos

e as

soci

ated

with

TA

U o

n a

num

ber

of m

easu

res.

Effi

cacy

of D

BT is

not

lim

ited

only

to

patie

nts

with

rec

urre

nt s

uici

dal a

nd s

elf-

inju

rious

beh

avio

ur

Line

han

et a

l., 1

99153

No

trea

tmen

t sp

ecifi

c ga

ins

in g

ener

alsa

tisfa

ctio

n de

spite

sig

nific

ant

impr

ovem

ents

inan

ger

redu

ctio

n an

d so

cial

adj

ustm

ent

(1) T

he a

utho

rs fo

und

a sig

nific

ant

redu

ctio

n in

the

freq

uenc

y an

d m

edic

al r

isk o

f par

asui

cida

lbe

havi

our

amon

g pa

tient

s w

ho r

ecei

ved

DBT

com

pare

d w

ith t

hat

for

cont

rol p

artic

ipan

ts

(2) D

BT e

ffect

ivel

y re

tain

ed p

atie

nts

in t

hera

py

(3) D

ays

of p

atie

nts’

psy

chia

tric

hos

pita

lisat

ion

wer

e fe

wer

for

part

icip

ants

who

rec

eive

d D

BT t

han

for

cont

rol p

artic

ipan

ts

(4) D

BT w

as n

ot d

iffer

entia

lly e

ffect

ive

in im

prov

ing

patie

nts’

dep

ress

ion,

hop

eles

snes

s, s

uici

deid

eatio

n or

rea

sons

for

livin

g

Line

han

et a

l., 1

99954

NR

(1) T

he a

utho

rs fo

und

a sig

nific

ant

redu

ctio

n in

sub

stan

ce a

buse

am

ong

part

icip

ants

ass

igne

d to

DBT

com

pare

d w

ith t

hose

ass

igne

d to

TA

U

(2) D

BT m

ore

effe

ctiv

ely

reta

ined

par

ticip

ants

in t

reat

men

t

(3) I

mpr

ovem

ents

in s

ocia

l and

glo

bal a

djus

tmen

t in

the

DBT

con

ditio

n w

ere

obse

rved

and

reac

hed

signi

fican

ce c

ompa

red

with

TA

U a

t fo

llow

-up

Line

han

et a

l., 2

00255

cont

inue

d

NR

(1) B

oth

trea

tmen

ts w

hen

com

bine

d w

ith L

AA

M w

ere

effe

ctiv

e in

red

ucin

g op

iate

use

and

mai

ntai

ning

the

red

uctio

n du

ring

the

4-m

onth

follo

w-u

p pe

riod

(2) C

VT+

12S

was

rem

arka

bly

effe

ctiv

e in

mai

ntai

ning

par

ticip

ants

in t

reat

men

t; 10

0% s

taye

d fo

rth

e en

tire

year

(3) P

artic

ipan

ts a

ssig

ned

to D

BT w

ere

signi

fican

tly m

ore

accu

rate

in s

elf-

repo

rtin

g op

iate

use

tha

nw

ere

thos

e as

signe

d to

CVT

+12

S

Appendix 3

106 TA

BLE

30

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: R

CTs

(con

t’d)

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d C

oncl

usio

nsac

cept

abili

ty o

f tre

atm

ent

Mun

roe-

Blum

and

Mar

zial

i,19

9556

NR

IGP

show

ed s

igni

fican

t im

prov

emen

ts o

n al

l maj

or o

utco

mes

(as

wel

l as

TAU

) at

follo

w-u

p. T

hegr

oup

ther

apy

appe

ars

mor

e co

st-e

ffect

ive

than

indi

vidu

al t

hera

py

Turn

er, 2

00057

NR

DBT

-orie

ntat

ed t

hera

py c

an b

e m

ore

effe

ctiv

e th

an p

rovi

ding

onl

y th

e su

ppor

tive

com

pone

nts

ofps

ycho

ther

apy.

DBT

-orie

ntat

ed p

atie

nts

show

ed g

reat

er im

prov

emen

ts t

han

patie

nts

rece

ivin

gC

CT

on

mea

sure

s of

sui

cide

and

sel

f-ha

rm b

ehav

iour

, sui

cide

idea

tion,

dep

ress

ion,

impu

lsive

ness

,an

ger

and

glob

al p

sych

olog

ical

func

tioni

ng, a

nd a

red

uctio

n in

day

s sp

ent

in p

sych

iatr

ic h

ospi

tals

Tyre

r et

al.,

200

358N

RT

he r

esul

ts s

how

ed n

o di

ffere

nce

with

reg

ard

to t

he o

utco

mes

bet

wee

n th

e tw

o gr

oups

.H

owev

er, t

he M

AC

T in

terv

entio

n w

as c

heap

er, l

ed t

o so

mew

hat

few

er e

piso

des

of s

elf-

harm

and

was

ass

ocia

ted

with

few

er s

uici

des

than

in t

he T

AU

gro

up

van

den

Bosc

h et

al.,

200

259Bo

th s

ubgr

oups

(BPD

and

BPD

with

sub

stan

ceab

use)

of p

atie

nts

appe

ared

to

get

alon

g ea

sily

by t

he s

econ

d w

eek.

Thr

ough

the

disc

ussio

n of

hom

ewor

k, t

he s

ubst

ance

-abu

sing

and

non-

subs

tanc

e-ab

usin

g pa

rtic

ipan

ts r

ealis

ed t

hat

they

shar

ed m

ost

of t

he e

ssen

tial b

orde

rline

prob

lem

s. A

ll pa

rtic

ipan

ts ju

dged

the

prog

ram

me

as v

alid

atin

g an

d he

lpfu

l. T

hey

felt

ackn

owle

dged

as

bord

erlin

e pa

tient

s an

d ju

dged

the

trea

tmen

t as

ver

y im

port

ant.

Sess

ion

atte

ndan

ce fo

r th

e to

tal g

roup

was

81%

(1) D

BT h

ad a

sub

stan

tially

low

er 1

2-m

onth

att

ritio

n ra

te t

han

TAU

(2) D

BT r

esul

ted

in g

reat

er r

educ

tions

in s

elf-

mut

ilatin

g be

havi

ours

and

sel

f-da

mag

ing

impu

lsive

acts

tha

n TA

U

(3) T

he b

enef

icia

l im

pact

on

the

freq

uenc

y of

sel

f-m

utila

ting

beha

viou

rs w

as fa

r m

ore

pron

ounc

edin

par

ticip

ants

who

rep

orte

d hi

gher

bas

elin

e fr

eque

ncie

s th

an in

tho

se r

epor

ting

low

er b

asel

ine

freq

uenc

ies

TA

BLE

31

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: n

on-R

CT

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d C

oncl

usio

nsac

cept

abili

ty o

f tre

atm

ent

Wilb

erg

et a

l., 1

99860

NR

“The

res

ults

sup

port

the

clin

ical

exp

erie

nce

that

a t

reat

men

t m

odel

com

bini

ng d

ay t

reat

men

t an

dou

tpat

ient

gro

up p

sych

othe

rapy

may

be

favo

urab

le fo

r se

lect

ed p

atie

nts

with

BPD

”


107


Appendix 4

Excluded studies

TABLE 32 Excluded studies

Study Population Reason for exclusion

RCTsAllard et al., 199281 Suicide attempters No BPD subgroup analysisChiesa et al., 200482 PD No BPD subgroup analysisClarkin et al., 200483 BPD Ongoing trial, no evaluable dataEvans et al., 199930 DSH No BPD subgroup analysis Manning, 199784 BPD Abstract, no evaluable dataPiper et al., 199385 PD No BPD subgroup analysisSimpson et al., 200486 BPD Combination of drug with DBTSloane et al., 197587 PD No BPD subgroup analysisSpringer et al., 199688 PD No BPD subgroup analysisStiwne et al., 199489 BPD Therapist assessmentWinston et al.,199490 PD No BPD subgroup analysis

Non-RCTsBohus et al., 200091 BPD DBTBohus et al., 200492 BPD DBTBrobin et al., 198793 BPD Case studyBattegay and Klaui, 198694 BPD Qualitative studyBuzov et al., 198595 BPD Qualitative studyChiesa et al., 200096 PD Qualitative studyClarkin et al., 199197 BPD ReviewClarkin et al., 199498 BPD No comparison Clarkin et al., 200126 BPD No comparisonDamman et al., 200199 BPD ReviewDolan et al., 1997100 PD Not eligible comparison (admitted vs not admitted patients)Hirvas, 1987101 BPD No comparisonKarterud et al., 2004102 BPD Not eligible comparison (day hospital vs Bateman’s MBT)Kent and Hartstone, 2000103 BPD Abstract, no dataKern et al., 1997104 BPD Case seriesKoenigsberg, 1982105 BPD Diagnostic paperLopez et al., 2004106 BPD No comparisonMeares et al., 1999107 BPD Not eligible comparison (treatment vs waiting list)Pfitzer et al., 1990108 BPD No comparisonRathus and Miller, 2002109 Suicide attempters AdolescentsRyle and Golynkina, 2000110 BPD No comparisonSchane and Kovel, 1988111 BPD Case seriesUshijima, 1994112 BPD Case seriesWildgoose et al., 2001113 BPD No comparison


109


Appendix 5

Consensus trial quality ratings according to Lackner’s quality checklist

TABLE 33 Quality ratings

Bateman Koons Linehan Linehan Linehan Munroe-Blum Turner Tyrer van den Wilberg and et al., et al., et al., et al., and Marziali, 200057 et al., Bosch et al.,

Fonagy, 200152 199153 199954 200255 199556 200358 et al., 199860

199951 200259

Q1 2 2 2 2 2 2 2 2 2 2Q2 2 2 2 2 2 2 2 2 2 2Q3 2 2 2 2 2 2 2 2 2 0Q4 0 0 0 0 0 0 0 0 0 0Q5 2 2 2 2 1 2 2 2 2 2Q6 2 2 0 2 2 1 2 2 2 1Q7 2 2 1 2 2 2 2 2 2 2Q8 2 2 2 2 2 2 2 2 2 2Q9 2 2 2 2 2 2 2 2 2 2Q10 0 0 0 0 0 0 0 0 0 0Q11 0 0 0 0 0 0 0 0 0 0Q12 2 2 2 2 2 2 2 2 2 2Q13 2 2 2 2 2 2 2 2 2 2Q14 0 1 1 1 1 0 1 0 0 0Q15 1 2 2 1 1 1 1 2 2 2Q16 0 0 0 0 0 0 0 0 0 0Q17 2 1 2 2 2 2 2 2 2 2Q18 0 2 0 0 0 2 0 2 0 0Q19 0 0 0 0 0 2 0 2 1 0Q20 2 2 2 2 2 1 2 1 2 1Q21 2 2 2 2 2 0 2 2 2 1Q22 2 2 2 2 2 1 2 2 2 1Q23 0 0 0 2 2 0 2 2 2 0Q24 0 2 2 2 2 2 0 2 2 2Q25 0 0 0 0 2 0 0 0 0 0Q26 2 0 0 2 2 2 2 2 2 1Q27 2 2 2 2 2 2 2 2 2 1Q28 0 0 0 0 0 0 0 0 0 2Q29 1 1 2 2 2 0 1 0 1 0Total 34 37 34 40 41 34 37 41 40 30

Q1. Were exclusion criteria specified and numberof exclusion/refusals reported?

Q2. Were formal diagnostic criteria used toconfirm [BPD] and/or inclusion criteriaspecified?

Q3. What was the method (e.g. randomisation)and adequacy of the method by whichpatients were allocated to treatment arms?

Q4. Was allocation concealed from those involvedin patient recruitment?

Q5. Were patients comparable on prognosticvariables, and were statistical proceduresused to adjust for differences in analyses?

Q6. How well were sample demographics andclinical characteristics described?

Q7. What was the source and representativenessof participants?

Q8. Was compliance with experimentalprocedure (e.g. attendance and checks foradherence with behavioral assignments)conducted?

Q9. How clearly was the content of therapeuticand control conditions (e.g. manualisedtreatment procedures) operationalised?

Q10. Were participants blind to treatmentallocation, and, if so, was integrity test

Appendix 5

110

conducted? (replaced with credibilitycriterion)

Q11. Were therapy credibility and expectancy forimprovement assessed? (Credibility criterion)

Q12 .Were the objectives and main outcomesspecified a priori?

Q13. Were outcome measures clearly describedand/or psychometrically sound outcomemeasure used?

Q14. Was a blind assessor used, and, if so, wasintegrity of blinding tested?

Q15. Were the number and reasons for withdrawalby group recorded?

Q16. Were details on side effects recorded bygroup?

Q17. What was the planned duration of trialincluding follow-up?

Q18. Were power calculations stated a priori?Q19. Was sample size (number per group)

adequate?

Q20. Were appropriate statistical analysesconducted (including correction for multipletests where applicable)?

Q21. Did presented results include data forreanalysis of main outcomes (e.g. pointestimates and measures of variability foreach primary outcome such as standarddeviations, 95% confidence interval)?

Q22. Were conclusions justified?Q23. Were withdrawals included in analyses?Q24. Was declaration of interests (e.g. source of

funding) stated?Q25. Was declaration of allegiance to therapy

stated?Q26. Was a post-treatment follow-up conducted

for all groups?Q27. Were cointerventions avoided or equal across

conditions?Q28. Were consecutive participants recruited?Q29. Was concurrent drug use recorded?


111


Appendix 6

British Medical Journal checklist for economic evaluations50

TABLE 34 Heard study68

Item Assessment

The study design1. The research question is stated The economic hypothesis was that DBT is more cost-effective

than TAU in the treatment of BPD

2. The economic importance of the research The disease is costly in terms of resources used. An intervention question is stated that reduces outcomes may impact on these costs

3. The viewpoint(s) of the analysis are clearly A societal perspective was taken, including hospital inpatient and stated and justified outpatient visits and physician visits. Costs incurred in the

community or the criminal justice system were not included

4. The rationale for choosing the alternative TAU is a relevant measure for evaluating the opportunity cost of programmes or interventions compared is stated the new treatment

5. The alternatives being compared are clearly DBT and TAU therapy is clearly describeddescribed

6. The form of economic evaluation used is stated Cost-effectiveness

7. The choice of form of economic evaluation is Yesjustified in relation to the questions addressed

Data collection8. The source(s) of effectiveness estimates are used Yes

as stated

9. Details of the design and results of effectiveness Brief description of design, no resultsstudy are given (if based on a single study)

10. Details of the method of synthesis or meta-analysis Based on a single trialof estimates are given (if based on an overview of a number of effectiveness studies)

11. The primary outcome measure(s) for the economic Yes (employment or global functioning cost-effectiveness ratios)evaluation are clearly stated

12. Methods to value health states and other Health states not valuedbenefits are stated

13. Details of the subjects from whom valuations NAwere obtained are given

14. Productivity changes (if included) are reported Yesseparately

15. The relevance of productivity changes to the Yesstudy question is discussed

16. Quantities of resources are reported separately Yesfrom their unit costs

17. Methods for the estimation of quantities and unit Yescosts are described

continued

Appendix 6

112

TABLE 34 Heard study68 (cont’d)

Item Assessment

18. Currency and price data are recorded Yes

19. Details of currency of price adjustments for Yes (Employment Cost Index used to inflate prices to 1999 inflation or currency conversion are given levels)

20. Details of any model used are given No model used

21. The choice of model used and the key parameters NAon which it is based are justified

Analysis and interpretation of results22. Time horizon of costs and benefits is stated Trial period (12 months)

23. The discount rate(s) is stated NA

24. The choice of rate(s) is justified NA

25. An explanation is given if costs or benefits are NAnot discounted

26. Details of statistical tests and confidence intervals t-Test, ordinary least squares regression, bootstrapping. CIs for are given for stochastic data overall results not given, only SDs for individual resources

reported

27. The approach to sensitivity analysis is given One-way and PSA

28. The choice of variables for sensitivity analysis Yesis justified

29. The ranges over which the variables are varied Local costs converted to national costs. No other sensitivity are stated analysis on costs reported

30. Relevant alternatives are compared Yea

31. Incremental analysis is reported Yes

32. Major outcomes are presented in a disaggregated Yesas well as aggregated form

33. The answer to the study question is given Yes

34. Conclusions follow from the data reported Yes

35. Conclusions are accompanied by the appropriate Yescaveats


113


TABLE 35 Byford study69

Item Assessment

Study design1. The research question is stated The economic hypothesis was that MACT is more cost-effective

than TAU in the treatment of DSH

2. The economic importance of the research question The disease is costly in terms of resources used. An intervention is stated that reduces outcomes may impact on these costs

3. The viewpoint(s) of the analysis are clearly stated A broad societal perspective was taken, including hospital, and justified community and social services and the criminal justice system

4. The rationale for choosing the alternative TAU is a relevant measure for evaluating the opportunity cost of programmes or interventions compared is stated the new treatment

5. The alternatives being compared are clearly MACT is not well described here. However, it is described in described the trial publication58

6. The form of economic evaluation used is stated Cost-effectiveness

7. The choice of form of economic evaluation is Yesjustified in relation to the questions addressed

Data collection8. The source(s) of effectiveness estimates are used Yes

as stated

9. Details of the design and results of effectiveness Brief description of design, no resultsstudy are given (if based on a single study)

10. Details of the method of synthesis or meta-analysis Based on a single trialof estimates are given (if based on an overview of a number of effectiveness studies)

11. The primary outcome measure(s) for the Yes (cost per QALY)economic evaluation are clearly stated

12. Methods to value health states and other benefits Yes (EQ-5D)are stated

13. Details of the subjects from whom valuations were Yesobtained are given

14. Productivity changes (if included) are reported Yesseparately

15. The relevance of productivity changes to the study Yesquestion is discussed

16. Quantities of resources are reported separately Yesfrom their unit costs

17. Methods for the estimation of quantities and unit Yescosts are described

18. Currency and price data are recorded Yes

19. Details of currency of price adjustments for inflation Yes (Hospital and Community Health Services Pay and Prices or currency conversion are given Index)

20. Details of any model used are given No model used

21. The choice of model used and the key parameters NAon which it is based are justified

continued

Appendix 6

114

TABLE 35 Byford study69 (cont’d)

Item Assessment

Analysis and interpretation of results22. Time horizon of costs and benefits is stated Trial period (12 months)

23. The discount rate(s) is stated NA

24. The choice of rate(s) is justified NA

25. An explanation is given if costs or benefits are not NAdiscounted

26. Details of statistical tests and confidence intervals t-Test, ordinary least squares regression, bootstrapping. CIs for are given for stochastic data overall results not given, only SDs for individual resources

reported

27. The approach to sensitivity analysis is given One-way and PS

28. The choice of variables for sensitivity analysis Yesis justified

29. The ranges over which the variables are varied Local costs converted to national costs. No other sensitivity are stated analysis on costs reported

30. Relevant alternatives are compared Yes

31. Incremental analysis is reported Yes

32. Major outcomes are presented in a disaggregated as Yeswell as aggregated form

33. The answer to the study question is given Yes

34. Conclusions follow from the data reported Yes

35. Conclusions are accompanied by the appropriate Yescaveats


115


Appendix 7

Case studies

Appendix 7

116 TA

BLE

36

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e of

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t co

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l A

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ion

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nt A

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7309

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ia12

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of t

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ffect

of o

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tient

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hera

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with

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ths

of

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e a

wee

k fo

r 1

year

, in

30 b

orde

rline

ps

ycho

ther

apy

patie

nts

. How

ever

, thi

s is

not

a tr

ueco

st–b

enef

it st

udy

This mapping uses data from a recentlypublished RCT of supervised self-help CBT in

primary care for patients with depression115 thatincorporated EQ-5D and CORE (ClinicalOutcomes in Routine Practice). These patientswere recruited from 17 primary healthcare teamsin the NHS. It used CORE rather than the BDI,but CORE is a depression-specific questionnairethat is similar in many ways to the BDI and it hasbeen mapped onto the BDI by the developer ofthe CORE (Barkham: personal communication).The mapping function was fitted to these data toprovide BDI data on each case.

This provided 62 patients with predicted BDIscores and EQ-5D data. The BDI score has been

fitted to EQ-5D data using a simple linear modelby ordinary least squares. The model produced inSPSS is summarised in Tables 37–39.

The interpretation of the constant at over 1 onlypresents problems for patients with BDI scoresbelow 5.0, which does not arise in the mean BDIscores to which it is applied in the studies reportedhere. More complex models such as curvilinearones did not greatly improve the fit of the model.

A better model would have fitted the original itemresponses (e.g. Brazier116), but because these BDIscores were derived from the CORE, item-leveldata were not available. The adjusted R-squaredsuggests at best a moderate fit and, moreimportantly, its dependence on the BDI meansthat many of the quality of life consequences forpeople suffering from BPD are not considered.The quality of life score probably under-representsthe impact of BPD Nonetheless, the BDI doesfocus on affect, so at least reflects the way in whichit impacts on the feelings and happiness of peoplewith BPD.


117


Appendix 8

Mapping BDI to EQ-5D

TABLE 37 Model summarya

Model R R2 Adjusted SE of the R2 estimate

1 0.534b 0.285 0.273 0.262183

a Dependent variable: EQ-5D overall utility (tariff).b Predictors: (constant), BDIPRED.

TABLE 38 ANOVAa

Model Sum of squares df Mean square F Significance

1 Regression 1.645 1 1.645 23.937 0.000b

Residual 4.124 60 0.069Total 5.770 61

a Dependent variable: EQ-5D overall utility (tariff).b Predictors: (constant), BDIPRED.

TABLE 39 Coefficientsa

Model Unstandardised coefficients Standardised coefficients t Significance

B SE �

1 (Constant) 1.110 0.111 9.954 0.000BDI score –0.021 0.004 –0.534 –4.893 0.000

a Dependent variable: EQ-5D overall utility (tariff).


133

Health Technology AssessmentProgramme

Prioritisation Strategy GroupMembers

Chair,Professor Tom Walley, Director, NHS HTA Programme,Department of Pharmacology &Therapeutics,University of Liverpool

Professor Bruce Campbell,Consultant Vascular & GeneralSurgeon, Royal Devon & ExeterHospital

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Professor Jon Nicholl, Director,Medical Care Research Unit,University of Sheffield, Schoolof Health and Related Research

Dr John Reynolds, ClinicalDirector, Acute GeneralMedicine SDU, RadcliffeHospital, Oxford

Dr Ron Zimmern, Director,Public Health Genetics Unit,Strangeways ResearchLaboratories, Cambridge

Director, Professor Tom Walley, Director, NHS HTA Programme,Department of Pharmacology &Therapeutics,University of Liverpool

Deputy Director, Professor Jon Nicholl,Director, Medical Care ResearchUnit, University of Sheffield,School of Health and RelatedResearch

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Programme Director, Professor Tom Walley, Director, NHS HTA Programme,Department of Pharmacology &Therapeutics,University of Liverpool

Chair,Professor Jon Nicholl,Director, Medical Care ResearchUnit, University of Sheffield,School of Health and RelatedResearch

Deputy Chair, Professor Jenny Hewison,Professor of Health CarePsychology, Academic Unit ofPsychiatry and BehaviouralSciences, University of LeedsSchool of Medicine

Dr Jeffrey AronsonReader in ClinicalPharmacology, Department ofClinical Pharmacology,Radcliffe Infirmary, Oxford

Professor Deborah Ashby,Professor of Medical Statistics,Department of Environmentaland Preventative Medicine,Queen Mary University ofLondon

Professor Ann Bowling,Professor of Health ServicesResearch, Primary Care andPopulation Studies,University College London

Dr Andrew Briggs, PublicHealth Career Scientist, HealthEconomics Research Centre,University of Oxford

Professor John Cairns, Professorof Health Economics, PublicHealth Policy, London School ofHygiene and Tropical Medicine,London

Professor Nicky Cullum,Director of Centre for EvidenceBased Nursing, Department ofHealth Sciences, University ofYork

Mr Jonathan Deeks, Senior Medical Statistician,Centre for Statistics inMedicine, University of Oxford

Dr Andrew Farmer, SeniorLecturer in General Practice,Department of Primary Health Care, University of Oxford

Professor Fiona J Gilbert,Professor of Radiology,Department of Radiology,University of Aberdeen

Professor Adrian Grant,Director, Health ServicesResearch Unit, University ofAberdeen

Professor F D Richard Hobbs,Professor of Primary Care &General Practice, Department ofPrimary Care & GeneralPractice, University ofBirmingham

Professor Peter Jones, Head ofDepartment, UniversityDepartment of Psychiatry,University of Cambridge

Professor Sallie Lamb, Professor of Rehabilitation,Centre for Primary Health Care, University of Warwick

Professor Stuart Logan,Director of Health & SocialCare Research, The Peninsula Medical School, Universities of Exeter &Plymouth

Dr Linda Patterson, Consultant Physician,Department of Medicine,Burnley General Hospital

Professor Ian Roberts, Professorof Epidemiology & PublicHealth, Intervention ResearchUnit, London School ofHygiene and Tropical Medicine

Professor Mark Sculpher,Professor of Health Economics,Centre for Health Economics,Institute for Research in theSocial Services, University of York

Dr Jonathan Shapiro, SeniorFellow, Health ServicesManagement Centre,Birmingham

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Diagnostic Technologies & Screening PanelMembers

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Ms Norma Armston,Lay Member, Bolton

Professor Max BachmannProfessor of Health Care Interfaces, Department of Health Policy and Practice,University of East Anglia

Professor Rudy BilousProfessor of Clinical Medicine &Consultant Physician,The Academic Centre,South Tees Hospitals NHS Trust

Dr Paul Cockcroft, Consultant MedicalMicrobiologist and ClinicalDirector of Pathology,Department of ClinicalMicrobiology, St Mary'sHospital, Portsmouth

Professor Adrian K Dixon,Professor of Radiology,University Department ofRadiology, University ofCambridge Clinical School

Dr David Elliman, Consultant Paediatrician/Hon. Senior Lecturer,Population Health Unit, Great Ormond St. Hospital,London

Professor Glyn Elwyn,Primary Medical Care Research Group,Swansea Clinical School,University of Wales Swansea

Mr Tam Fry, HonoraryChairman, Child GrowthFoundation, London

Dr Jennifer J Kurinczuk,Consultant ClinicalEpidemiologist,National PerinatalEpidemiology Unit, Oxford

Dr Susanne M Ludgate, MedicalDirector, Medicines &Healthcare Products RegulatoryAgency, London

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Professor Lindsay WilsonTurnbull, Scientific Director,Centre for MR Investigations &YCR Professor of Radiology,University of Hull

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Chair,Dr John Reynolds, ChairDivision A, The John RadcliffeHospital, Oxford RadcliffeHospitals NHS Trust

Professor Tony Avery, Head of Division of PrimaryCare, School of CommunityHealth Services, Division ofGeneral Practice, University ofNottingham

Ms Anne Baileff, ConsultantNurse in First Contact Care,Southampton City Primary CareTrust, University ofSouthampton

Professor Stirling Bryan,Professor of Health Economics,Health Services Management Centre,University of Birmingham

Mr Peter Cardy, ChiefExecutive, Macmillan CancerRelief, London

Professor Imti Choonara,Professor in Child Health,Academic Division of ChildHealth, University ofNottingham

Dr Robin Ferner, ConsultantPhysician and Director, WestMidlands Centre for AdverseDrug Reactions, City HospitalNHS Trust, Birmingham

Dr Karen A Fitzgerald,Consultant in PharmaceuticalPublic Health, National PublicHealth Service for Wales,Cardiff

Mrs Sharon Hart, Head of DTB Publications, Drug &Therapeutics Bulletin, London

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Professor Stan Kaye,Cancer Research UK Professor of Medical Oncology,Section of Medicine, The Royal Marsden Hospital,Sutton

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Dr Andrew Prentice, SeniorLecturer and ConsultantObstetrician & Gynaecologist,Department of Obstetrics &Gynaecology, University ofCambridge

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Professor Gene Feder, Professorof Primary Care R&D,Department of General Practiceand Primary Care, Barts & theLondon, Queen Mary’s Schoolof Medicine and Dentistry,London

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Professor Alan Horwich,Director of Clinical R&D,Academic Department ofRadiology, The Institute ofCancer Research, London

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Dr John C Pounsford,Consultant Physician,Directorate of Medical Services,North Bristol NHS Trust

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Professor Barry Cookson,Director, Laboratory ofHealthcare Associated Infection,Health Protection Agency,London

Professor Howard Cuckle,Professor of ReproductiveEpidemiology, Department ofPaediatrics, Obstetrics &Gynaecology, University ofLeeds

Dr Katherine Darton, Information Unit, MIND – The Mental Health Charity,London

Professor Carol Dezateux, Professor of PaediatricEpidemiology, London

Mr John Dunning,Consultant CardiothoracicSurgeon, CardiothoracicSurgical Unit, PapworthHospital NHS Trust, Cambridge

Mr Jonothan Earnshaw,Consultant Vascular Surgeon,Gloucestershire Royal Hospital,Gloucester

Professor Martin Eccles, Professor of ClinicalEffectiveness, Centre for HealthServices Research, University ofNewcastle upon Tyne

Professor Pam Enderby,Professor of CommunityRehabilitation, Institute ofGeneral Practice and PrimaryCare, University of Sheffield

Mr Leonard R Fenwick, Chief Executive, Newcastleupon Tyne Hospitals NHS Trust

Professor David Field, Professor of Neonatal Medicine,Child Health, The LeicesterRoyal Infirmary NHS Trust

Mrs Gillian Fletcher, Antenatal Teacher & Tutor andPresident, National ChildbirthTrust, Henfield

Professor Jayne Franklyn,Professor of Medicine,Department of Medicine,University of Birmingham,Queen Elizabeth Hospital,Edgbaston, Birmingham

Ms Grace Gibbs, Deputy Chief Executive,Director for Nursing, Midwifery& Clinical Support Services, West Middlesex UniversityHospital, Isleworth

Dr Neville Goodman, Consultant Anaesthetist,Southmead Hospital, Bristol

Professor Alastair Gray,Professor of Health Economics,Department of Public Health,University of Oxford

Professor Robert E Hawkins, CRC Professor and Director ofMedical Oncology, Christie CRCResearch Centre, ChristieHospital NHS Trust, Manchester

Professor Allen Hutchinson, Director of Public Health &Deputy Dean of ScHARR,Department of Public Health,University of Sheffield

Dr Duncan Keeley,General Practitioner (Dr Burch& Ptnrs), The Health Centre,Thame

Dr Donna Lamping,Research Degrees ProgrammeDirector & Reader in Psychology,Health Services Research Unit,London School of Hygiene andTropical Medicine, London

Mr George Levvy,Chief Executive, MotorNeurone Disease Association,Northampton

Professor James Lindesay,Professor of Psychiatry for theElderly, University of Leicester,Leicester General Hospital

Professor Julian Little,Professor of Human GenomeEpidemiology, Department ofEpidemiology & CommunityMedicine, University of Ottawa

Professor Rajan Madhok, Medical Director & Director ofPublic Health, Directorate ofClinical Strategy & PublicHealth, North & East Yorkshire& Northern Lincolnshire HealthAuthority, York

Professor David Mant, Professor of General Practice,Department of Primary Care,University of Oxford

Professor Alexander Markham, Director, Molecular MedicineUnit, St James’s UniversityHospital, Leeds

Dr Chris McCall, General Practitioner, TheHadleigh Practice, Castle Mullen

Professor Alistair McGuire,Professor of Health Economics,London School of Economics

Dr Peter Moore, Freelance Science Writer, Ashtead

Dr Sue Moss, Associate Director,Cancer Screening EvaluationUnit, Institute of CancerResearch, Sutton

Mrs Julietta Patnick, Director, NHS Cancer ScreeningProgrammes, Sheffield

Professor Tim Peters,Professor of Primary CareHealth Services Research,Academic Unit of PrimaryHealth Care, University ofBristol

Professor Chris Price, Visiting Chair – Oxford, ClinicalResearch, Bayer DiagnosticsEurope, Cirencester

Professor Peter Sandercock,Professor of Medical Neurology,Department of ClinicalNeurosciences, University ofEdinburgh

Dr Eamonn Sheridan,Consultant in Clinical Genetics,Genetics Department,St James’s University Hospital,Leeds

Dr Ken Stein,Senior Clinical Lecturer inPublic Health, Director,Peninsula TechnologyAssessment Group, University of Exeter

Professor Sarah Stewart-Brown, Professor of Public Health,University of Warwick, Division of Health in theCommunity Warwick MedicalSchool, LWMS, Coventry

Professor Ala Szczepura, Professor of Health ServiceResearch, Centre for HealthServices Studies, University ofWarwick

Dr Ross Taylor, Senior Lecturer, Department ofGeneral Practice and PrimaryCare, University of Aberdeen

Mrs Joan Webster, Consumer member, HTA –Expert Advisory Network

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HTA

Health Technology Assessm

ent 2006;Vol. 10: No. 33

Com

puterised cognitive behaviour therapy for depression and anxiety update

Computerised cognitive behaviour therapy for depression and anxietyupdate: a systematic review and economic evaluation

E Kaltenthaler, J Brazier, E De Nigris, I Tumur, M Ferriter, C Beverley, G Parry, G Rooney and P Sutcliffe


HTAHealth Technology AssessmentNHS R&D HTA Programme

The National Coordinating Centre for Health Technology Assessment,Mailpoint 728, Boldrewood,University of Southampton,Southampton, SO16 7PX, UK.Fax: +44 (0) 23 8059 5639 Email: [email protected]://www.hta.ac.uk ISSN 1366-5278

FeedbackThe HTA Programme and the authors would like to know

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We look forward to hearing from you.

September 2006

psychological therapies including dialectical behaviour therapy for borderline personality disorder

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