early findings from nida’s clinical trials network “women and trauma” study denise hien, ph.d....
Post on 03-Jan-2016
215 Views
Preview:
TRANSCRIPT
Early findings from NIDA’s Clinical Trials Network “Women and Trauma” Study
Denise Hien, Ph.D.Denise Hien, Ph.D.
Senior Research Scientist, Social Intervention Group,Columbia University School of Social Work
Executive Director, Women’s Health Project Treatment and Research Center, Addiction Institute of New York, St. Luke’s\Roosevelt Hospital Center
115th Annual American Psychological Association MeetingSan Francisco, CaliforniaAugust 18, 2007
PLEASE DO NOT CITE CONTENTS OF PRESENTATION WITHOUT PERMISSION OF THE AUTHOR
Scope of the Problem1 in 2 women in the U.S. experience some type of traumatic event (Kessler, 1995)
Approximately 33% of females under age 18 experience sexual abuse (Finkelhor, 1994; Wyatt, 1999)
Prevalence rates of PTSD in community samples have ranged from 6% to 36% (Breslau, 1991; Kilpatrick, 1987; Norris, 1992; Resnick, 1993)
Studies have documented PTSD rates among substance using populations to be between 14%-60% (Brady, 2001; Donovan,
2001; Najavits, 1997; Triffleman, 2003)
Neurobiological Changes in Response to Traumatic Stress
Limbic System -- Hippocampus and Amygdala (Affect and Memory, e.g, Ledoux, 2000; van der
Kolk, 1996)
Neurotransmitters and Peptides (Numbing and Depression, e.g., Pitman, 1991, Southwick, 1999)
Changes in Hormonal System (HPA axis) (Arousal, e.g., Yehuda, 2000)
Historical Context for the Study of Trauma & Addiction
1970 1980 1990
DSM-IIIR broadens criteria for
PTSD
Miller’s work with criminal justice
population
Women’s movement and
grassroots advocacy for
battered women
Crack/ Cocaine epidemic
PTSD studies with male veterans
with/out substance use
Fullilove’s snowball sample
Historical Context for the Study of Trauma & Addiction
1990 1995 2000 2007
Herman’s Trauma
and Recovery published
Violence declared
public health epidemic
Chilcoat and Breslau self-medication
model
Kendler et al. co-twin study suggesting causal link
between abuse and SUD
National awareness of
PTSD and addiction following 9/11/01
SAMSHAfindings
published
Manualized integrated
trauma and SUD tx
RCTs of integrated PTSD and
SUD tx
Differences between Co-morbid PTSD vs. PTSD-only behavioral treatmentsAddition of components focused on coping and cognitive restructuring related to substance use (cravings and relapse triggers)
Concurrent Model : Additional components may be
integrated and delivered concurrently
Sequential Model: Initial phase may focus on
substance abuse related symptoms in preparation for
working on trauma related symptoms later
PTSD/SUD Behavioral Treatments
ATRIUM: Addictions and Trauma Recovery Integrated Model (Miller & Guidry, 2001)
Seeking Safety (Najavits, 1998; www.seekingsafety.org)
TARGET - Trauma Affect Regulation: Guidelines for Education and Therapy (Ford; www.ptsdfreedom.org)
Transcend (Donovan et al., 2001)
CTPCD - Concurrent Treatment of PTSD and Cocaine Dependence (Back et al., 2001) SDPT/ARTS: Substance Dependence PTSD Therapy/Assisted Recovery from Trauma and Substances (Triffleman et. al, 1999)
Washington Node Residence XII
New York Node ARTC Long Island Node
Lead Node
New England Node LMG Programs
South Carolina Node Charleston Center
Florida Node The Village
Florida Node Gateway Community
Ohio Valley Node Maryhaven
NIDA Clinical Trials Network Women & Trauma Sites
CTN Long Island Node Team
Denise Hien, Lead InvestigatorEdward Nunes, Node PIGloria Miele, Training DirectorLisa Cohen, Protocol ManagerAimee Campbell, Project DirectorJennifer Lima, Node CoordinatorHuiping Jiang, Statistician David Liu, NIDA Liaison
Participating Nodes and CTPs
Node Node PI(s) Protocol PI CTP Site PI Location
Florida
Jose Szapocznik & Daniel Santisteban
Lourdes Suarez-Morales
The Village Michael Miller Miami, FL
Gateway Community
Candace Hodgkins
Jacksonville, FL
New England
Kathleen Carroll
Melissa Gordon
LMG Programs Samuel Ball Stamford, CT
New York John RotrosenMarion Schwartz
Addiction Research & Treatment Corporation
Robert Sage Brooklyn, NY
Ohio Valley Gene SomozaGreg Brigham
Maryhaven Greg BrighamColumbus, OH
South Carolina
Kathleen BradyTherese Killeen
Charleston Center Mark CowellCharleston, SC
WashingtonDennis Donovan & Betsy Wells
Betsy Wells Residence XII Karen Canida Kirkland, WA
CTN Women & Trauma: A Unique Opportunity
Chance to conduct a “practical” clinical trial on SS while maintaining a rigorous controlShorter treatment window and doseOpen-group, rolling admissions format paralleling real worldCommunity treatment providers as research cliniciansTreatment as usual while receiving research intervention
Study Aims
To assess the effectiveness of adding Seeking Safety (SS) and Women’s Health Education (WHE) groups to ongoing substance abuse treatment.
To evaluate the transportability of a 12- session group version of SS in community drug/alcohol treatment settings.
Pre-Post Control Group Design
Pre-Treatment
1 - 4 Weeks
Treatment
6 Weeks
Post Treatment Follow-up
46 Weeks
1 Week 3 Month 6 Month 12 Month
Pre-screening, Screening, Baseline, Randomization, Individual Session w/ Counselor
12 Twice Weekly Group Sessions (rolling admission)
Treatment Groups
Seeking Safety (SS)Short term, manualized treatmentCognitive BehavioralFocused on addiction and trauma
Women’s Health Education (WHE)Short term, manualized treatmentPsychoeducationalFocused on women’s health information and issues
Seeking Safety
Developed as a group treatment for PTSD/SUD womenBased on CBT models of SUDs, PTSD treatment, women’s treatment and educational researchEducates patients about PTSD and SUD’s and their interactionGoals include abstinence and decreased PTSD symptomsFocuses on enhancing coping skills, safety and self-careActive, structured treatment - therapist teaches, supports and encouragesCase management
Najavits, 2002; www.seekingsafety.org
Women’s Health Education
EmpowermentInformation is empowering
Self-careSubstance abuse and trauma interfere with ability to care for oneself
Exposure to traumatic stress can affect people on many different levels of functioning including:
emotionalbehavioral physical
There is significant overlap of PTSD and physical symptoms
In the national comorbidity survey, use of medical care services was highest in PTSD and panic disorder patients (Kessler, 1995)
Assessment Domains (1 of 2)Demographics
Substance Use Disorder DiagnosisCIDI – Composite International Diagnostic Interview
Substance UseSUI – Substance Use Inventory (Primary)
Biological – Urine/Saliva Screen (Primary)
ASI – Addiction Severity Index
HIV Risk Behaviors: RBS – Risk Behavior Survey
Health and Family Network (ASI; add-on questions)
Assessment Domains (2 of 2)
PTSD Diagnosis and SymptomsCAPS – Clinician Administered PTSD Scale (Primary)
PSS-SR – Post Traumatic Stress Symptoms – Self Report
Trauma Exposure: Lifetime Events Checklist
Psychiatric Symptoms: BSI – Brief Symptom Inventory
Service Utilization: Non-study mental health, medical, substance abuse treatment services
In-Treatment Measures(baseline, weekly thru treatment,1 week post)
PTSD Symptoms (PSS-SR)
Biologically Confirmed Substance Abstinence and Proportion of Days Used
Substance Use Inventory (SUI)
Urine Drug Screen (UDS)
Saliva Alcohol Screen (ST)
Service Utilization (NSMS)
Medication (ASL)
Adverse Events (AE)
Participant Eligibility Criteria
Inclusionfemale, 18 - 65 years oldused an illicit substance within the past six months and have a current diagnosis of illicit drug/alcohol abuse or dependencePTSD or Sub-threshold PTSDenrolled at participating community treatment program
Exclusion advanced stage medical disease (AIDS, TB)impaired mental status (MMSE: less than or equal to 21)significant risk of suicidal/homicidal intent or behaviorhistory of schizophrenia-spectrum diagnosisactive psychosis (prior 2 months)involved in PTSD-related litigationrefuses to be audio or videotaped
EnrollmentInitial Eligibility Screen
N=1,963
Eligible for Full ScreenN=1,212 (62%)
IneligibleN=751
Completed ScreenN=541 (45%)
No/Incomplete ScreenN=671
Completed BaselineEligible for Randomization
N=379 (70%)
IneligibleN=162
RandomizedN=353 (93%)
Not Randomized N=26
Sample Characteristics (N=353)
Variable percent or M (S.D.)
Age (years) 39.2 (9.3) Race/ethnicity
Hispanic or Latino 6.5 Black/African American 34.0
White 45.6 Mixed 13.3 Other 0.6
Marital status Married 33.3
Widowed/Divorced 29.3 Never Married 37.4
Education Years 12.5 (2.4)
PTSD Diagnosis and Severity at Baseline (N=353)
Variable percent or M (S.D.) PTSD Diagnosis
Full Subthreshold
80.4 19.6
CAPS Total Score 62.8 (19.4)
PSS-SR Severity 45.6 (10.8)
PSS-SR Frequency 38.7 (15.3)
Substance Use Disorders at Baseline (N=353)
Substance Use Diagnosis percent
Current Alcohol Use Disorder Diagnosis 62.0
Current Marijuana Use Disorder Diagnosis 35.4
Current Opioid Use Disorder Diagnosis 33.1
Current Cocaine Use Disorder Diagnosis 72.8
Current Stimulant Use Disorder Diagnosis 8.2
Note: not exclusive categories
Lifetime Trauma Exposure (N=353)
Event percent
Physical Assault Childhood Physical Abuse 58.7
Lifetime Physical Abuse 93.8 Sexual Assault
Childhood Sexual Abuse 70.1 Lifetime Sexual Violence 89.5
Captivity 40.3 Sudden, Violent Death 19.3 Life-threatening Illness 39.8 Transportation Accident 72.7 Natural Disaster 53.1
Data Analytic Approach for In-Treatment Outcomes
Mixed effect models were used to model the outcome measures of interest as a function of baseline levels, time, treatment, site and their interactions. A non-randomized sample of naturalistically-occurring “wait list” controls was examined with baseline as the pre-test and assessment during 1st week of treatment as the post-test.Analyses addressing impact of treatment attendance on outcomes were conducted.Between group comparisons of service utilization, medication, and adverse events were conducted.
Modeled PSS-SR Severity during Treatment
25
30
35
40
45
50
55
Basel
ine Wk1
Wk2
Wk3
Wk4
Wk5
Wk6
Post
SS WHE
Mea
n S
ever
ity
Modeled Abstinence Rate during Treatment
30
3540
45
5055
60
65
7075
80
Basel
ine Wk1
Wk2
Wk3
Wk4
Wk5
Wk6
Post
SS WHE
% A
bstin
ent
Modeled Days of Use during Treatment (past 7 days)
Day
s of
Use
(%
)
0
5
10
15
20
25
Basel
ine Wk1
Wk2
Wk3
Wk4
Wk5
Wk6
Post
SS WHE
Secondary Analyses: Six Week Pre- “Post” Changes for Non-Randomized Naturalistic Wait Group (N=20)
25
30
35
40
45
50
55
Basel
ine Wk1
Wk2
Wk3
Wk4
Wk5
Wk6
Post
SS WHE WAIT
Mea
n S
ever
ity
Secondary Analyses: Treatment Attendance Rates
Treatment Group*
N Mean (sd) Median
SS 170 6.3 (4.4) 7
WHE 172 5.9 (4.3) 6.5
*No significant differences between groups
Secondary Analyses: Effects of treatment attendance on post-treatment abstinence rates
Source DF 2 p-value
Baseline Abstinence 1 48.07 <.001
Race 3 2.39 n.s.
Site 5 48.95 <.001
Age 1 0.27 n.s.
Education 1 0.00 n.s.
Time 1 4.33 <.05
Treatment 1 0.04 n.s.
Treatment Attendance 1 7.47 <.001
Secondary Analyses: Effects of treatment attendance on post-treatment days of use
Source DF 2 p-value
Baseline Use 1 24.09 <.001
Race 3 1.48 n.s.
Site 5 14.20 0.01
Age 1 0.85 n.s.
Education 1 1.28 n.s.
Time 6 11.78 n.s.
Treatment 1 0.05 n.s.
Baseline Use*Time 6 24.89 <.001
Treatment Attendance 1 7.07 <.01
Service Utilization*Baseline Treatment
Service% Receiving % Receiving
Visits/Week M (SD)
Mental Health SS
WHE
73.7
80.7
83.8
78.9
1.30 (1.6)
1.50 (2.7)
Outpatient Medical SS
WHE
49.7
48.3
62.7
58.3
0.20 (0.5)
0.20 (0.4)
Inpatient Drug Treatment (# nights)
SS
WHE
20.0
14.8
3.5
4.5
0.04 (0.4)
0.05 (0.3)
ER/Hospital SS
WHE
18.9
17.7
24.7
32.7
0.04 (0.1)
0.05 (0.1)
12-Step Meeting SS
WHE
76.0
72.3
83.1
81.4
3.40 (4.1)
2.80 (3.7)
Total SS
WHE
91.4
93.2
97.9
95.5
5.00 (5.3)
4.60 (6.0)*Service use data collected in # visits unless otherwise noted; no differences between SS and WHE on any variable
Medication (past 30 days)
Baseline Post Treatment
% %
Prescribed for Psychiatric Problems SS
WHE
42.6%
40.1%
46.3%
31.3%
p-value 0.63 0.02
Adverse Event Descriptions
0
5
10
15
20
25
30
35
Wors
enin
g PTSD
Incr
ease
d Sub
stan
ce U
se
Anxie
ty/P
anic
Depre
ssiv
e Sym
ptom
sOth
er
Fre
quen
cy
SummaryDespite a number of differences in site characteristics, overall, both SS and WHE groups led by community substance abuse counselors can reduce PTSD symptoms at a statistically significant level.
Those in Seeking Safety groups improved significantly more quickly on PTSD symptoms over the course of six weeks of treatment.The number of sessions received significantly predict lowered levels of SUD symptoms, as did baseline severity of use.
Although participants in both groups experienced study related adverse events, there were no differences in rates between groups, and further, these did not impact treatment attendance or post-treatment outcomes.
Utilization of other services including outpatient drug and mental health visits, twelve step meetings, medical visits and hospitalizations did not differ across treatment groups.
Implications
With supervision, counselors in drug treatment programs can be trained to conduct and deliver Seeking Safety and Women’s Health groups safely.
Consideration of the impact of trauma-focused assessments should also be given in the treatment process; all participants received weekly self-reported assessments of their symptoms.
Being assigned to a group with other women who have been identified as having trauma or PTSD may also have a powerful effect on expectancies and outcomes, as those in Women’s Health also improved significantly on PTSD symptoms.
Longer-term groups and additional approaches may be needed to impact substance use and abuse.
THANK YOU!THANK YOU!
353 Women who participated in the study
28 Research Assistants, Assessors, and Coordinators
39 Therapists and Supervisors
11 Project Directors and Protocol Principal Investigators
27 Quality Assurance Monitors and Data Managers
NIDA U10DA13035
Comparison of Existing Trauma / SUD- Focused Treatment Research
Najavits, 1998
Triffleman, 2000
Brady et. al., 2001
Donovan, 2001
Hien et al.,
2004
N 27 Women
19 Mixed
39 Mixed
46 Men
107Women
Design No Control RCT No Control No Control RCT
Sessions, Timeframe & Modality
24, 3 mos., group
40, 5 mos.,
individual
164 mos.,
individual
603 mos., group
243 mos.,
individual
Tx Content SS SDPT, 12-Step
CTPSD, CBT, Exposure
CBT, RPT, Soc Support
SS, RPT, TAU
Follow Up 3 mos. 1 mo. 6 mos. 6/12 mos. 6/9 mos.
Results SU, PTSD & Depression SXs
SU, PTSD, Psych SXs
SU, PTSD & Depression SXs
SU, PTSD SXs
SU, PTSD, Psych SXs at 6 mos
Summary Statistics for Post-treatment PSS-SR Severity Modeled by Baseline PTSD Severity, Demographics, Treatment Group, Time, Site, and their Interactions
Parameter DF 2 p-value
PSS-SR Baseline 1 71.73 <.001
Race 3 1.34 n.s.
Site 5 24.19 <.001
Age 1 0.68 n.s.
Education 1 4.97 <.05
Time 1 1.08 n.s.
Treatment 1 6.81 <.01
Time*Treatment 1 4.96 <.05
Time* PSS-SR Baseline 1 12.35 <.001
Summary Statistics for Post-treatment PSS-SR Frequency Modeled by Baseline PTSD Frequency, Demographics, Treatment Group, Time, Site, and their Interactions
Parameter DF 2 p-value
PSS-SR Baseline 1 76.74 <.001
Race 3 0.64 n.s.
Site 5 27.60 <.001
Age 1 0.95 n.s.
Education 1 5.07 <.05
Time 1 1.47 n.s.
Treatment 1 8.55 <.01
Time*Treatment 1 5.28 <.05
Time* PSS-SR Baseline1 15.32 <.001
Summary Statistics for Post-treatment Days of Use Modeled by Baseline Days of Use, Demographics, Treatment Group, Time, Site, and their Interactions
Parameter DF 2 p-value
Baseline Days of Use 1 21.66 <.001
Race 3 1.26 n.s.
Site 5 18.37 <.01
Age 1 0.50 n.s.
Education 1 0.95 n.s.
Time 6 11.90 <.10
Treatment 1 0.01 n.s.
Baseline Days of Use*Time 6 20.80 <.01
Summary Statistics for Post-treatment Abstinence Rates Modeled by Baseline Abstinence, Demographics, Treatment Group, Time, Site, and their Interactions
Parameter DF 2 p-value
Baseline Abstinence 1 51.12 <.001
Race 3 2.10 n.s.
Site 5 44.18 <.001
Age 1 0.18 n.s.
Education 1 0.00 n.s.
Time 1 0.02 n.s.
Treatment1 0.12 n.s.
top related