1. Effective Treatments for PTSD in Women with SUD Denise Hien, Ph.D., dhien@ccny.cuny.edu Professor and Adjunct Senior Research Scientist City University of New York, Subprogram in Clinical Psychology & Columbia University College of Physicians & Surgeons 138 th American Public Health Association Annual Meeting November 10, 2010 | Denver, Colorado

2. Presenter Disclosures (1)The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: Denise Hien, Ph.D. 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, 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. Pandora Problem

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

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; www.seekingsafety.org) Transcend (Donovan et al., 2001)

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

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 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), 48-55.

9. Washington Node Residence XII New York Node ARTC 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 Trauma Group Study Sites

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 NodeNode PI(s)Protocol PICTPSite PILocation 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 ProgramsSamuel Ball Stamford, CT New York John Rotrosen Marion Schwartz Addiction Res & TX Corporation Robert Sage Brooklyn, NY Ohio Valley Gene Somoza Greg Brigham Maryhaven Greg Brigham Columbus, OH South Carolina Kathleen Brady Therese Killeen Charleston Center Mark Cowell Charleston, SC Washington Dennis Donovan Betsy WellsResidence XIIKaren 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.

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

14. 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-screen, Screening, Baseline, Randomization, Individual Session w/ Counselor 12 Twice Weekly Group Sessions (rolling admission)

15. Assessment Measures PTSD 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. Study Enrollment Initial Eligibility Screen N=1,963 Screening N=541 Baseline N=370 Randomized N=353 Ineligible N=751 (38%) No-show to Screen N=671 (34%) Ineligible n=171 (32%) Not Randomized N=17 (5%)

17. Sample Characteristics (N=353)

18. Baseline PTSD Severity (N=353)

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

20. PSS-SR Trauma Symptom Severity for ITT Sample (N=353) 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) 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 12345 Improvement From NoneDrug Use PTSD Symptoms Global Drop Out 1 None 0.5030.2080.0870.0620.140 2 Drug Use 0.1110.6560.0160.1310.085 3 PTSD 0.1490.0810.3100.3670.093 4 Global 0.0260.1610.0600.6920.062 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. 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. 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. 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. Attendance Matters

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: 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? What are meaningful outcomes that tell us whether and how theories of psychotherapy map onto reality? Transdisciplinary approaches. Transdisciplinary approaches. Integrating mind/body: Physical Health, STD and HIV Integrating mind/body: Physical Health, STD and HIV Pharmacotherapies Pharmacotherapies Multimedia interventions for a wider audience Multimedia interventions for a wider audience Need novel designs, innovative statistical methods, and broader yet more systematic criteria. Need novel designs, innovative statistical methods, and broader yet more systematic criteria.

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