1. Effective Treatments for PTSD in Women with SUD
Denise Hien, Ph.D.,
Professor and Adjunct Senior Research Scientist
City University of New York, Subprogram in Clinical Psychology & Columbia University College of Physicians & Surgeons
138th American Public Health Association Annual Meeting
November 10, 2010 | Denver, Colorado
Very honored to be here to usher in a new and vibrant phase in psychology at CUNY that will bring together an interdisciplinary dialogue between differing and unique perspectives in psychology. And I thank all the students who helped to organize this effort.
I’m pleased to be able to spend some time sharing my passions for research with all of you and the area to which I’ve devoted my career which is in studying how to bridge the gap between research and practice in the treatment of traumatic stress and addictions. I will admit debating on the title for this talk…the alternate one was “the curious case of politics in the science behind evidence based practice” but I decided to be less provocative in the end.

2. Presenter Disclosures
Denise Hien, Ph.D.
(1) The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:
No relationships to disclose

3. Scope: Trauma and Addiction
1 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)
20% to 65% of individuals in treatment for SUD reporting assault histories (G. R. Brown & Anderson, 1991; P. J. Brown et al., 1995)
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)

4. Pandora Problem
Pandora, the first woman, created by the God of Fire and endowed with many gifts, was treacherously presented with a box containing the evils of humankind. When a naturally curious Pandora opens the box, the evils escape.
Realizing what has happened, Pandora struggles to close the box, able to do so in time to keep Hope from escaping. 17

5. Phases of Trauma Treatment
Stabilize
Process
Affect Regulation
Exposure
Distress Tolerance
Cognitive
Somatosensory

6. Combined Behavioral Treatments for Trauma and Addictions
ARTS: Assisted Recovery from Trauma and Substances (Triffleman et. al, 1999)
ATRIUM: Addictions and Trauma Recovery Integrated Model (Miller & Guidry, 2001)
COPE: Concurrent Treatment with Prolonged Exposure (Back and Kileen, in development)
CBT for PTSD (McGovern, in development)
Seeking Safety (Najavits, 1998;
Transcend (Donovan et al., 2001)
Approaches currently being used
Some individual some group
Some sequential some simultanous
Some more research than others

7. Overall Summary of Trauma/SUD Psychotherapy Studies
CBT shows promise in treating PTSD/SUD
PTSD treatments did not make patients worse, and improved PTSD, substance use and general psychiatric symptoms
Integrated counseling may be one of the key program features that impacts outcomes.
More research needed to examine the duration, scope, timing and combination of components to identify optimal model of PTSD/SUD treatment integration
Though much progress past decade, research that addresses needs of wo w/ co-occuring d/o s & hx of trauma remains at rel early stage
In sum
Positive results provide justification to continue this line of research in controlled tx trials with range of SU populations in order to further demonstrate feasibility of these approaches
Concerns about addressing PTSD not bourne out

8. Limits of Randomized Controlled Trials for Patients with PTSD/SUD
Restricted participant characteristics
Heterogeneity in diagnosis and concurrent treatment
Inflexible treatment implementation
Practical guidelines regarding participant treatment participation
Therapist characteristics and training that do not reflect community practitioners
Using community clinicians in a train-the-trainer model
What do we do, when our subject of study doesn’t conform to the research methods that the field considers the gold standard?
Hien, DA, Cohen, LC & Campbell, A. In (2009). Methodological innovation in a clinical trial using hybrid models to increase the utility and efficiency of psychotherapy research for patients with comorbid mental health and substance disorders. Professional Psychology: Research and Practice, 32 (1),

9. NIDA Clinical Trials Network Trauma Group Study Sites
Washington Node Residence XII
Ohio Valley Node Maryhaven
New England Node LMG Programs
New York Node ARTC
South Carolina Node Charleston Center
Florida Node Gateway Community
Florida Node The Village

10. CTN Long Island Node Team
Denise Hien, Lead Investigator Edward Nunes, Node PI Gloria Miele, Training Director Lisa Cohen, Protocol Manager Aimee Campbell, Project Director Jennifer Lima, Node Coordinator Huiping Jiang, Statistician Mei-Chen Hu, Statistician David Liu, NIDA Liaison

11. Participating Nodes and CTPs
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 Rotrosen
Marion Schwartz
Addiction Res & TX Corporation
Robert Sage
Brooklyn, NY
Ohio Valley
Gene Somoza
Greg Brigham
Maryhaven
Columbus, OH
South Carolina
Kathleen Brady
Therese Killeen
Charleston Center
Mark Cowell
Charleston, SC
Washington
Dennis Donovan
Betsy Wells
Residence XII
Karen Canida
Kirkland, WA

12. Study Aims Primary Analyses:
To assess the effectiveness of adding a trauma focused therapy to ongoing substance abuse treatment.
To evaluate the transportability of a 12- session group version of SS in community drug/alcohol treatment settings.
Secondary Analyses:
To identify for whom and how the trauma focused therapy worked best.
Can community counselors be trained and meet adherence levels?
Can it be done effectively and safely?

13. Treatment Groups Seeking Safety (SS) Short term, manualized treatment
Cognitive Behavioral
Focused on addiction and trauma
Women’s Health Education (WHE)
Psychoeducational
Focused on women’s health info and issues

14. Pre-Post Control Group Design
Pre-screen, Screening, Baseline, Randomization, Individual Session w/ Counselor
Pre-Treatment
1 - 4 Weeks
Treatment
6 Weeks
12 Twice Weekly Group Sessions (rolling admission)
Post Treatment Follow-up
46 Weeks
1 Week
3 Month
6 Month
12 Month

15. Assessment Measures PTSD symptoms Substance use symptoms
PTSD Symptom Scale- Self-Report (PSS-SR)
Clinician Administered PTSD Scale (CAPS)
Substance use symptoms
Substance Use Inventory (SUI)
Addiction Severity Index (ASI)
Alcohol Composite
Drug Composite
Maximum number of days of use

16. Initial Eligibility Screen
Study Enrollment
Ineligible
N=751 (38%)
No-show to Screen
N=671 (34%)
Initial Eligibility Screen
N=1,963
Screening N=541
Ineligible
n=171 (32%)
Randomization occurred over 20 month period in
751 ineligible at brief screen, 671 eligible but never came in for screening, 171 attended screen and were ineligible, 370 completed screen and baseline
Top reasons for ineligibility at screen = No PTSD (n=66), recent suicide attempt/ideation (n=31), no SUD (n=19), did not return to complete CAPS (n=13)
Baseline N=370
Randomized N=353
Not Randomized
N=17 (5%)

17. Sample Characteristics (N=353)

18. Baseline PTSD Severity (N=353)
CAPS Range= 0-136
PSS-SR Severity = 17-85
PSS-SR Frequency = 17-68

19. Baseline Substance Use Disorders (N=353)
Note: not exclusive categories

20. PSS-SR Trauma Symptom Severity for ITT Sample (N=353)
There was a significant study phase * Tx interaction effect indicating a sig difference bet the 6 wk intervention and f/u period.
During intervention phase mean PSS-SR decreased significantly for both groups.
After 1st wk scores decreased more quickly in SS though at the end of tx no significant differences. reductions were maintained at 12 mo fu
Also sig interaction between severity*time indicating that participants with higher bl scores improved more quickly then those w lower Bl scores
Significant education effect – higher education resulted in lower PSS-SR severity. Site effect was significant
Completer analyses -subgroup of pts attended at least 6 sessions.
Same pattern during interventions PSS-SR scores dropped more rapidly during tx for SS and no sig differences although trend lower scores for SS at fu points.
For participants who stayed engaged for the entire study period those in SS had sig lower scores at the end of week 6.
Hien, Wells, Jiang, Suarez-Morales, Campbell, Cohen, Miele, Kileen, Brigham, Robinson, Zhang (2009). Multi-site randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders, Journal of Consulting and Clinical Psychology.

21. Abstinence Rates for ITT Sample (N=353)
The treatment effect is not significant (p=0.77) on participants’ abstinence. BL status has a significant effect (p<0.0001). Significant site effect (p<.0001).
Hien et al. (2009). Multi-site randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders, Journal of Consulting and Clinical Psychology.

22. Examining Functional Relationships is Critical to understanding how and for whom the trauma treatments work best

23. Temporality of Treatment Response
Improvement To 1 2 3 4 5
Improvement From
None
Drug Use
PTSD Symptoms
Global
Drop Out
0.503
0.208
0.087
0.062
0.140
0.111
0.656
0.016
0.131
0.085
PTSD
0.149
0.081
0.310
0.367
0.093
0.026
0.161
0.060
0.692
Hien et. al, (2010). Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? A Secondary Analysis from “Women and Trauma” Multi-Site Randomized Study. American Journal of Psychiatry.

24. Alcohol Misuse
Stronger Seeking Safety treatment effects on PTSD hyperarousal symptoms (PSS-SR) compared with WHE over time were found for women with alcohol misuse at baseline.
Alcohol misuse defined as daily drinking or at least 1 day of alcohol to intoxication
Hien, Campbell, Hu, et al. (In press). The role of alcohol misuse on PTSD outcomes for women in community treatment? A secondary analysis of NIDA’s Women and Trauma study, Drug and Alcohol Dependence

25. Attendance Matters
Three consistent and distinct attendance patterns emerged: Completers, Droppers, and Titrators.
Titrators in Seeking Safety had lower rates of alcohol use from 1-week through 12 month follow-up compared to the health education group; cocaine results were similar but not statistically significant.
Latent class pattern mixture model, revealing 3 different attendance pattern classes: Completers (never decreased below 80% probability of attendance), Droppers (never exceeded a 41% probablility of attendance, and Titrators (50-80% probablility of attendance).
Hien, Morgan-Lopez, Saavedre, et al. (submitted) Can Less be More?: A secondary analysis of CTN “Women and Trauma” study. Journal of Consulting and Clinical Psychology.

26. Summary
PTSD changes found to impact SUD outcome/ No evidence substance use reduction improved PTSD.
Findings of all analyses consistent with a self-medication model of coping with PTSD.
Addressing trauma related symptoms did not negatively impact substance use recovery. Instead trauma-focused treatment can lead to improvements in SUD outcomes in the context of PTSD symptom reduction.
Clinicians working with alcohol misusers should attend to hyperarousal; those with cocaine/stimulant users may want to pay attention to avoidance/numbing cluster throughout treatment.
Empirical basis for recommending PTSD-focused and integrated interventions for improved substance use outcomes in patients with severe symptoms.
Attendance patterns and other contextual factors are important to consider in evaluating treatment outcomes.

27. Implications for Dissemination
In order for psychotherapy research studies to inform and deepen our understanding of treatment and be relevant to the community, we must consider:
What are meaningful outcomes that tell us whether and how theories of psychotherapy map onto reality?
Transdisciplinary approaches.
Integrating mind/body: Physical Health, STD and HIV
Pharmacotherapies
Multimedia interventions for a wider audience
Need novel designs, innovative statistical methods, and broader yet more systematic criteria.
Though much progress past decade, research that addresses needs of wo w/ co-occuring d/o s & hx of trauma remains at rel early stage
In sum
Positive results provide justification to continue this line of research in controlled tx trials with range of SU populations in order to further demonstrate feasibility of these approaches
Concerns about addressing PTSD not bourne out

28. Available from APA Press
Hands on guide for clinicians and providers seeking to treat women who suffer from trauma and the effects of substance abuse

29. THANK YOU!
Participants and staff on the NIDA CTN Study:
353 Participants; 28 Research Assistants, Assessors, and Coordinators; 39 Therapists and Supervisors; 11 Project Directors and Protocol Principal Investigators; 27 Quality Assurance Monitors and Data Managers
My wonderful colleagues: Nathilee Caldeira, Ph.D., Aimee Campbell, Ph.D., Lisa Cohen, Ph.D., Mei-Chen Hu, Ph.D., Huiping Jiang, Ph.D., Lisa Litt, Ph.D., Antonio Morgan-Lopez, Ph.D., Gloria Miele, Ph.D., Edward V. Nunes, MD, Lesia Ruglass Ph.D, and Lissette Saavedra, Ph.D.
ADD CTN GRANT NUMBER