Evidence-Based Treatments for People with Severe

Mental Illness

Kim T. Mueser

Center for Psychiatric Rehabilitation

Different Definitions of Recovery

Medical definition– No symptoms or signs of disability

Personal definition– Subjective meaning of experience of coming

to grips with having a mental illness, and moving on to developing a meaningful life

Functional definition– Objective recovery dimensions

One Definition of Recovery

“Recovery is a process, a way of life, an attitude, and a way of approaching the day’s challenges. It is not a perfectly linear process. At times our course is erratic and we falter, slide back, regroup, and start again. . .

…The need is to reestablish a new and valued sense of integrity and purpose within and beyond the limits of the disability; the inspiration is to live, work, and love in a community in which one makes a significant contribution.” Patricia Deegan, 1988

Components of Recovery (SAMHSA)

HopeSelf-directedEmpowermentRespectResponsibility

IndividualizedStrengths-basedNon-linearHolisticPeer support

Recovery-Oriented Services (Farkas)

Focused on person, not illness Involve individuals in treatment

planning & implementationRespect self-determination & choice Address health, resiliency, functional

goals

What are Evidence-Based Practices?

Services that have demonstrated their effectiveness in helping consumers to achieve important outcomes in multiple different rigorous research trials

Research trials conducted by different people and achieve similar outcomes

Programs are standardized (e.g., manuals)

Rationale for Assertive Community Rationale for Assertive Community Treatment (ACT; Stein & Test)Treatment (ACT; Stein & Test)

Many impaired clients with SMI don’t access services at local community mental health agencies

Frequent psychiatric crises due to lack of treatment, resulting in “revolving door” client in and out of hospitals

Core rationale for ACT: for clients who don’t come to clinics for services, bring the services to them in the community

ACT also used to facilitate transition from long-term hospitals to community

ACT Program ComponentsACT Program Components

Low case manager to client ratio (1:10)

Services provided in clients’ natural

settings

24-hour coverage

Shared caseloads among clinicians

Direct, not brokered services

Time unlimited services

Research on ACT

Over 30 controlled studiesMost research in the U.S.Most studies in urban settingsMajority of participants have

schizophreniaAverage follow-up = 18 Months

Controlled ACT Research

25 Studies

Rationale for Supported Employment (Becker & Drake: Individual Placement & Support-IPS)

Most people with SMI want to work: 55-70% Competitive employment rates low: 10-25% Benefits of work:

– better financial standing– improved sense of self– increased social contacts– facilitates coping with symptoms– personally meaningful

Tradition “train-place” and sheltered vocational rehabilitation programs don’t work—”place-train approaches more effective

IPS Supported Employment

Eligibility is based on client choice Supported employment services integrated with

psychiatric treatment Competitive employment is the goal Job search starts soon after client expresses

interest in work Employment specialist actively involved in job

development with and for client Follow-along supports are continuous Client preferences are important, regarding desired

work & disclosure of psychiatric disability All clients receive benefits counseling

Rationale for Social Skills Training (Bellack, Liberman)

Poor premorbid social functioning common in many clients

Impaired social functioning core feature of severe mental illness

Good social functioning related to independent living and fewer hospitalizations

Improved, rewarding relationships are common recovery goal

Social Skills Training (SST)

Social learning principles used to teach

social skills:

Modeling

Role playing

Positive and corrective feedback

Homework

In vivo practice

Research on SST

Numerous controlled studies

Primary treatment population is schizophrenia

Recent meta-analysis completed (Kurtz &

Mueser, 2008)

22 RCTs

Evaluation of outcomes organized with respect

to hypothesized continuum of proximal-distal

effects

Effects of SST on Proximal and Distal Outcomes

Proximal Mediational Intermediate Intermediate Distal

Mastery Performance Psychosocial Negative Relapses and

tests of tests of social/ functioning symptoms other symptoms

SST living skills

knowledge  

 

ES = 1.20 ES = .52 ES = .52 ES = .40 ES = .23

Proximal Distal

(More immediate outcomes) (More long-term outcomes)

Rationale for Family Psychoeducation

Many clients have close contact with relatives Clients benefit from family support in

achieving recovery goals Families need information about mental

illness and treatment to reduce burden of care

Reducing family stress can protect against relapses

Families (including the client) can be members of the “treatment team”

Family Psychoeducation

Provided by professionals Long-term (over 6 months) Single- & multiple-family group formats Focus on education, stress-reduction,

communication and problem solving skills

Oriented towards future, not past Treatment models: Falloon, Kuipers,

Barrowclough, McFarlane, Anderson, Mueser)

Research on Family Psychoeducation

Short-term psychoeducation (3 months or less) less effective

Family intervention reduces relapses and rehospitalizations

Family psychoeducation improves client functioning

Modest reductions in family burden Benefits to caregivers of shorter term family

education programs conducted by advocacy organizations (e.g., NAMI)

Effects of Family Psychoeducation for Schizophrenia on Relapses Over 2 Years

Rationale for Illness Management and Recovery (Gingerich & Mueser)

Medication non-adherence common problem Relapses and hospitalizations frequent,

disruptive, and costly Even with optimal pharmacological treatment,

persistent symptoms common Historically, clients have been viewed as

passive recipients of treatment Need to fully engage clients in their own

treatment, and develop capacity for illness self-management

IMR Program and Research

IMR based on comprehensive review of research on illness self-management training

Incorporates specific illness self-management strategies supported by research in over 40 studies: Education Medication adherence strategies Relapse prevention Skills training to develop social support Coping skills training for persistent symptoms

Core Ingredients of IMR

5 to 10 months of weekly or twice weekly sessions 10 educational handouts Practitioners use motivational, educational, and

cognitive behavioral techniques Clients set and pursue personal recovery goals Clients practice skills in IMR sessions Home assignments are developed together Significant others are involved

IMR Modules

1. Recovery Strategies

2. Practical Facts about Mental Illness

3. The Stress-Vulnerability Model

4. Building Social Support

5. Using Medication Effectively

Modules, cont’d

6. Drug and Alcohol Use

7. Reducing Relapses

8. Coping with Stress

9. Coping with Problems and Persistent Symptoms

10. Getting Your Needs Met in the Mental Health System

11. Healthy Lifestyles

Research on IMR Program

Pilot study showed IMR was feasible to implement, retain clients in treatment, and associated with improved outcomes

National Implementing EBPs study showed IMR could be implemented at 12 routine community mental health centers with good fidelity over 2 years

Multiple RCTs show IMR is more effective at improving illness self-management and outcomes, conducted in different countries

Free, widely implemented, and translated into at least 15 languages

Adaptations for special populations (comorbid physical disorders, intellectual disability, inpatient, forensic)

Rationale for Cognitive-Behavior Therapy (CBT) for Psychosis

Persistent psychotic symptoms present in 25-40% of persons with schizophrenia

Psychotic symptoms predict relapses and rehospitalizations

High distress associated with persistent psychotic symptoms

CBT for Psychosis

Collaborative partnership formed with client

Education about stress-vulnerabilityExploration with client about alternative

interpretations for psychotic symptomsNon-confrontationalBehavioral testsMultiple models: Fowler, Beck, Morrison,

Granholm, Chadwick

Research on CBT for Psychosis: Meta-analysis (Wykes et al., 2008)

34 controlled studies Psychotic symptoms: ES = .37 Negative symptoms: ES = .44 Functioning: ES = .38 Mood: ES = .36 Comparable effects of group & individual

modalities Similar results for more recent meta-analyses

Rationale for Integrated Treatment for Co-Occurring Disorders

Substance use disorders common in serious mental illness

Substance use worsens course of illness, leads to premature mortality

Traditional approaches to treating mental illness and substance abuse separately are ineffective

Integrated treatment is solution to problem

Rates of Lifetime Substance Use Disorder (SUD) among Recently Admitted Psychiatric Inpatients (N = 325) (Mueser et al., 2000)

Integrated Treatment (e.g., Mueser, Noordsy, Drake, & Fox)

Mental health and substance abuse treatment:– Delivered concurrently– By the same team or group of clinicians– Within the same program– Burden of integration is on the treatment team

Other Features of Dual Disorder Programs

Group and individual approaches Comprehensive services Minimization of treatment-related stress Harm reduction philosophy Motivational enhancement, based on stages

of change/treatment: – Precontemplation / Engagement– Contemplation / Persuasion– Preparation or Action / Active treatment– Maintenance / Relapse prevention

Summary of Research on Integrated Treatment for Dual Disorders (IDDT)

IDDT associated with better substance abuse & related outcomes

Strongest effects for group counseling, contingency management, and residential treatment

Group counseling most studied treatment modality

Fidelity to principles of IDDT associated with superior outcomes

Fidelity to IDDT Model Improves Outcome (McHugo et al., 1999)

Importance of Cognitive Remediation

Cognitive impairment common in persons with SMI

Related to a broad range of functioning, including self-care, independent living, social relationships, and work

Associated with reduced response to rehabilitation (e.g., social skills training, supported employment)

Cognitive Remediation Definition

“Cognitive remediation is an intervention targeting cognitive deficit using scientific principles of learning with the ultimate goal of improving  functional outcome. Its effectiveness is enhanced when provided in a context (formal or informal) that provides support and opportunity for extending everyday functioning.”(Cognitive Remediation Therapy Expert Working Group; SIRS meeting, 2012)

Cognitive Remediation Programs

Methods derived from initial work on traumatic brain injury

Attempts to improve cognitive functioning in SMI have a long history (40+ years)

Cognitive remediation approaches involve a variety of methods: – Computer-based practice– Strategy coaching– Learning coping/compensatory strategies

Computer-Based Practice

Repeated task practice (“drill and practice”) of exercises using cognitive software

Variety of software programs available

Alternative: paper and pencil exercises

“Route” Scoring

COGPACK Software

Meta-Analyses of Cognitive Enhancement

McGurk et al. (2007): 26 studies, 1151 subjects Wykes et al. (2011): 40 studies, 2000 subjects;

included ratings of methodological rigor Examined effects on cognitive functioning,

symptoms, psychosocial functioning Explored moderators of effects, including

characteristics of consumers and cognitive remediation programs, and provision of adjunctive psychiatric rehabilitation

Program Characteristics

Range of intensity and duration of programs: –3 to 75 hours over 1 to 100 weeks–1 to 5 hours per week

The average program provides about 20 hours of practice delivered over about 16 weeks

Comparative Effect Sizes for McGurk et al. (orange) and Wykes et al. (blue) Meta-analyses on Cognitive Functioning, Symptoms, & Functioning

Differences in Functional Outcomes Between Cognitive Remediation Studies that did vs. did not also Provide Psychiatric Rehabilitation

Conclusions from Meta-Analyses

Cognitive remediation (CR) improves cognitive functioning, BUT:

CR does not automatically generalize to day-to-day functioning, UNLESS it is combined with psychiatric rehabilitation

Psychiatric rehabilitation may provide new learning opportunities critical to reaping the benefits of improved cognitive functioning

Primary work has been on combining CR with vocational rehabilitation or social skills training

Thinking Skills for Work Program (TSW)

Cognitive remediation program integrated with vocational services

Targets improved cognitive functioning – cognitive practice, strategy coaching– teaching coping/ compensatory strategies

Cognitive specialist member of vocational rehabilitation team

Works collaboratively with employment specialist

Components of TSW

1. Assessment

1. Cognitive Skills Training

2. Training in Coping/Compensatory Strategies

1. Job Search Planning

1. Job Support Consultation

Previous Research on TSW

CR + SE vs. SE only at 4 mental health agencies in NYC (McGurk t al., 2005, 2007)

TSW + VR vs. VR only at Mt. Sinai Vocational Services in NYC (McGurk et al., 2009)

CR+ IPW vs. IPW along at Manhattan Psychiatric Center (Lindenmayer et al., 2010)

TSW+VR vs. VR (Ikebuchi et al., 2014) TSW+ VR vs.VR alone in Brooklyn mental

health center (McGurk et al. under review) TSW+ IMR+VR vs. VR alone in Brooklyn

mental health center (active)

Cognitive Enhancement for People with Mental Illness Who Do Not Respond to Supported Employment: A Randomized Controlled Trial

McGurk et al., Am. J.

Psychiat. Advance

Access, 2015

Inclusion Criteria

Severe mental illnessEnrolled in supported employmentSE NonrespondersNot worked for past 3 months or

more in SE program, orLost a job in SE that lasted less than

months

Methods

• Randomized to TSW +E-SE or E-SE Alone• Comprehensive Assessment:• Baseline, post CR, 12- & 24-month post-

randomization • Cognitive (MATRICS) • Symptom (PANSS) • Quality of life (QLS)• 24 month weekly tracking of work activity

Cognitive Outcomes

• Strong TSW effects associated with:• overall composite score of

cognitive functioning, and measures of cognitive flexibility and verbal learning

• Stronger exposure analyses than intent-to-treat (ITT) analyses

Emerging Practices with a Growing Evidence Base

CBT for PTSD in people with SMI Supported housing Social cognition training Training in comorbid physical illness self-

management Peer support Healthy lifestyle promotion

– Smoking– Weight loss– Cardiovascular fitness

Epidemiology of Trauma in General Population

36-81% report experiencing a traumatic event in their lifetime

National Comorbidity Survey of 6000 between 15-54:– 60% men exposed to traumatic event– 51% women exposed to traumatic event– 17% men & 13% women exposed to 3+ events

Even higher rates found in special subpopulations (e.g., homeless, serious mental illness, substance use disorders)

Importance of Trauma in Severe Mental Illness

Trauma & other adverse events in childhood

increase risk of developing SMI

Multiple traumatization is common

History of trauma associated with more severe

symptoms & distress

Service users report traumatic experiences are

important but neglected in treatment

Numerous studies show high rates of trauma in SMI,

both before & after onset of illness (51-97%)

Trauma In SMI (N=275)

Source: Mueser et al. (1998)

Rates of PTSD in Clients with SMI

Per

cen

t w

ith

PT

SD

Interactive Model Of Trauma, PTSD, & Co-occurring Disorders (Mueser et al., 2002)

TRAUMA

PTSD

WORKINGALLIANCE

TRAUMAHISTORY

SUBSTANCEABUSE

SYMPTOM SEVERITY& FUNCTIONING

ILLNESSMANAGEMENT

SERVICES

Development of Cognitive Restructuring Program

Integration of treatment with other services Minimal exclusion criteria to enhance

application to broad population Flexible model that can adapt to wide range of

severe psychopathology and other challenges across different vulnerable populations

Incorporation of education, breathing retraining, and cognitive restructuring methods

Therapy Modules

1. Overview2. Crisis plan3. Breathing retraining4. Psychoeducation I5. Psychoeducation II6. Cognitive restructuring I7. Cognitive restructuring II8. Generalization Training & Termination

Research on CBT for PTSD In SMI Model

2 open pilot feasibility studies, 1 in NH, 1 in NJ

RCT comparing CBT for PTSD with treatment as usual (TAU) in rural NH/VT

RCT comparing CBT for PTSD with Brief program in urban NJ

Open pilot of Brief program as stand-alone program

Closed enrollment group format version of program implemented in community mental health centers

RCT OF CBT FOR PTSD IN NH (Mueser et al., 2008)

RCT of CBT vs. TAU (N = 108) Exposure to CBT: 81% Conducted at 4 local CMHCs in NH & VT CBT provided by 6 Ph.D. & 1 M.A. clinician Assessments conducted at baseline, post-

treatment, 3-months, 6-months Primary focus on PTSD knowledge, trauma-

related beliefs, PTSD, other symptoms

Limitations of NH RCT

Lack of ethnic/racial heterogeneity Rural setting Most clinicians academically trained Lack of data on impact of program on

functional outcomes & service utilization Limited diagnostic heterogeneity, especially

for schizophrenia-spectrum disorders CBT compared to TAU, not active control

NJ CBT for PTSD RCT

Collaboration with UNDMJ/UBHC in New Jersey Conducted at 5 sites in urban settings, more

minority clients Evaluation of CBT for PTSD when delivered by

frontline clinicians Comparison of CBT to Brief Treatment Assessment of longer-term functional

outcomes, services, & costs Larger sample: N = 201 Funded by NIMH Pilot study conducted in NJ to establish

feasibility of implementing program at study sites (Lu et al., 2011)

Bridging the Gap from Science to Practice

Multiple rehabilitation approaches effective for persons with severe mental illness (SMI)

Most consumers have little or no access to EBPs Mental health professionals not trained in EBPs

for SMI nor required to have competence for licensure

Multiple calls to improve access to EBPs (Institute of Medicine, President’s New Freedom Commission report)

Need for more effective approaches to implementing EBPs

Successful Implementation of EBPs is Possible!

High quality implementation of a practice is different from sustainability of practice

Effective implementation: – Fidelity to program model– Local adaptations as needed

Lessons learned from the Implementing EBPs Project (Bob Drake, PI: SAMHSA, RWJ Foundation)

National Implementing EBPs Project (PI: Bob Drake)

Supported by SAMHSA and RWJ Foundation Focus on standardization of EBPs and

training methods (ACT, SE, IMR, IDDT, FPE) Development of “Resource kits” or “Toolkits”

for each EBP Evaluation of implementation of each EBP in

4-12 routine mental health treatment settings Fidelity to EBP implementation monitored

every 6 months for 2 years

Resource Materials Included in Each EBP Toolkit

Manual for practitioners with background and description of treatment methods

Implementation guidelines for program leaders, administrators

Information brochures for different stakeholder groups (e.g., consumers, families, clinicians)

Introductory videotape (15-20 min.) Practice demonstration videotape (1.5-3 hrs.) Fidelity scale

IMR Resource Materials Included in Toolkit, cont’d

Standardized outcome measures Introductory powerpoint presentation Training powerpoint presentation Supplementary articles/chapters on

practice (including research reviews) Educational handouts for consumers* * For some EBPs (e.g., IMR)

Standardized Training and Consultation Approach

Implementation trainers/experts for each practice

Introductory “Kick-off” training (2-3 hours) for all site staff at agency

2-day intensive training for staff implementing practice

Access to ongoing consultation and supplementary training from experts

Evaluation Approach

Primary focus on fidelity of implementation to each practice

Fidelity assessed at baseline, 6-, 12-, 18-, and 24-months later

Qualitative methods to identify barriers and facilitators of successful and sustained implementation

53 routine community mental health treatment sites participated

Most sites implemented 2 EBPs (some 1)

Fidelity Results: Implementing EBPs Project (3 = “Good”)

Interpretation of Findings

All EBPs could be successfully implemented at multiple agencies

Implementation required 1 year to reach good fidelity for most practices

Fidelity levels maintained over follow-up period of 2 years

Caution against interpreting differences in fidelity scores between practices: fidelity scales of higher scoring EBPs based more on structural (e.g., caseload size) than skill (e.g., motivational interviewing) components

What have we learned about critical components of implementation?

Core Factors:Organizational/leadership factorsFundingTraining/technical assistanceMonitoringStakeholder supporrt

Organization/Leadership

Commitment to cooperate among multiple agencies or organizations if required

Full support of leadership within organization

Involvement of agency director Designated director/supervisor of practice Designated practitioners responsible for

implementing practice

Organization/Leadership (cont’d)

Agency/clinical/rehabilitation director involved in training

Director/supervisor develops expertise in practice

Practitioners have necessary educational backgrounds

Implementation of practice is part of job Structural support for practice: the

problem of relying on “champions”

Organization/Leadership (cont’d)

Time allotted for practitioners to: a) learn practice; b) participate in supervision; c) provide practice

Reduction of required contacts/billable hours

Expectations for all roles in providing practice clearly established in advance

Regular meetings between agency director and practice director/supervisor

Funding

Resources required to pay for training, consultation, and technical assistance

Issue of whether and how services will be reimbursed

Funding or resources required to offset practitioner time required to learn practice

Funding for monitoring implementation Stakeholder support funding?

Training and Technical Assistance

Initial training is just the start Need to build ongoing consultation and

technical assistance into plan Ongoing/retraining plan to address staff

turnover Expertise in practice gradually develops

within agency Technical assistance helpful in

monitoring

Monitoring Implementation Efforts

Fidelity assessments:– Program fidelity – Practitioner competence

Consumer access to program Consumer outcomes Cost/billing Stakeholder committee

Conclusions & Future Directions

EBPs can be implementedOrganization, planning, expertise,

and commitment are primary ingredients