1 / 47

CTN 0015: Preliminary findings from the “Women and Trauma” Study

CTN 0015: Preliminary findings from the “Women and Trauma” Study. Denise Hien, Ph.D. Research Scientist, Social Intervention Group, Columbia University School of Social Work

jin
Download Presentation

CTN 0015: Preliminary findings from the “Women and Trauma” Study

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CTN 0015: Preliminary findings from the “Women and Trauma” Study Denise Hien, Ph.D. 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Addiction Institute of New York, St. Luke’s\Roosevelt Hospital Center St. Petersburg, Florida December 7, 2006 PLEASE DO NOT CITE CONTENTS OF PRESENTATION WITHOUT PERMISSION OF THE AUTHOR

  2. “The past isn’t dead, it isn’t even past.” -William Faulkner

  3. Scope of the Problem • 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) • 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. 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) Neurobiological Changes in Response to Traumatic Stress

  5. Historical Context for the Study of Trauma & Addiction Women’s movement and grassroots advocacy for battered women Crack/ Cocaine epidemic Fullilove’s snowball sample 1970 1980 1990 PTSD studies with male veterans with/out substance use DSM-IIIR broadens criteria for PTSD Miller’s work with criminal justice population

  6. Historical Context for the Study of Trauma & Addiction Kendler et al. co-twin study suggesting causal link between abuse and SUD Chilcoat and Breslau self-medication model SAMSHA findings published Herman’s Trauma and Recovery published 1990 1995 2000 2006 RCTs of integrated PTSD and SUD tx National awareness of PTSD and addiction following 9/11/01 Violence declared public health epidemic Manualized integrated trauma and SUD tx

  7. Differences between Co-morbid PTSD vs. PTSD-only behavioral treatments • Addition 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

  8. 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: Substance Dependence PTSD Therapy(Triffleman et. al, 1999)

  9. NIDA Clinical Trials Network Women & Trauma Sites Washington Node Residence XII New England NodeLMG Programs Ohio Valley NodeMaryhaven New York NodeARTC Long Island Node Lead Node South Carolina NodeCharleston Center Florida NodeGateway Community Florida NodeThe 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 Eva Petkova, Lead Statistician Huiping Jiang, Statistician David Liu, NIDA Liaison

  11. Participating Nodes and CTPs

  12. CTN Women & Trauma: A Unique Opportunity • Chance to conduct a “practical” clinical trial on SS while maintaining a rigorous control • Shorter treatment window and dose • Open-group, rolling admissions format paralleling real world • Community treatment providers as research clinicians • Treatment as usual while receiving research intervention

  13. 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.

  14. Pre-Post Control Group Design Pre-screening, Screening, Baseline, Randomization, Individual Counselor Session Pre-Treatment 1 - 4 Weeks Treatment 6 Weeks 12 Twice Weekly Group Sessions Post Treatment Follow-up 46 Weeks 1 Week 3 Month 6 Month 12 Month

  15. 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 information and issues

  16. Seeking Safety • Developed as a group treatment for PTSD/SUD women • Based on CBT models of SUDs, PTSD treatment, women’s treatment and educational research • Educates patients about PTSD and SUD’s and their interaction • Goals include abstinence and decreased PTSD symptoms • Focuses on enhancing coping skills, safety and self-care • Active, structured treatment - therapist teaches, supports and encourages • Case management Najavits, 2002; www.seekingsafety.org

  17. Women’s Health Education • Empowerment • Information is empowering • Self-care • Substance abuse and trauma interfere with ability to care for oneself • Exposure to traumatic stress can affect people on many different levels of functioning including: • emotional • behavioral • 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)

  18. Assessment Domains • Demographics • Substance Abuse/Dependence Diagnosis • CIDI – Composite International Diagnostic Interview • Substance Use • SUI – 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)

  19. Assessment Domains • PTSD Diagnosis and Symptoms • CAPS – 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: TSR – Treatment Services Review (medication)

  20. In-Treatment Measures(baseline, weekly through treatment,1week 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)

  21. Participant Eligibility Criteria Inclusion • female, 18 - 65 years old • used an illicit substance within the past six months and have a current diagnosis of illicit drug/alcohol abuse or dependence • PTSD or Sub-threshold PTSD • enrolled 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 behavior • history of schizophrenia-spectrum diagnosis • active psychosis (prior 2 months) • involved in PTSD-related litigation • refuses to be audio or videotaped

  22. Enrollment Initial Screen N=1,963 Ineligible N=751 Eligible for Baseline N=1,212 (62%) No Full Screen N=751 Completed Baseline N=541 (45%) Ineligible N=162 Eligible for Randomization N=379 (70%) Not Randomized (multiple reasons) N=26 Randomized N=353 (93%)

  23. Sample Characteristics (N=353)

  24. PTSD Diagnosis and Severity at Baseline (N=353)

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

  26. Lifetime Trauma Exposure (N=353)

  27. 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. • Additional analyses on the impact of treatment attendance on outcomes were conducted.

  28. PTSD In-Treatment Outcomes: PSS-SR severity modeled from pre-treatment to post-treatment weekly by treatment group

  29. PTSD In-Treatment Outcomes: PSS-SR frequency modeled from pre-treatment to post-treatment weekly by treatment group

  30. SUD In-Treatment Outcomes: Abstinence rates modeled from pre-treatment to post-treatment weekly by treatment group

  31. SUD In-Treatment Outcomes: Days of use modeled from pre-treatment to post-treatment weekly by treatment group

  32. Secondary Analyses: Six Week Pre- “Post” Changes for Non-Randomized Naturalistic Wait Group(N=20) Wait List

  33. Secondary Analyses: Treatment Attendance Rates *No significant differences between groups

  34. Secondary Analyses: Effects of treatment attendance on post-treatment abstinence rates

  35. Secondary Analyses: Effects of treatment attendance on post-treatment days of use

  36. Comments • Though all participants met PTSD and SUD diagnoses as per study inclusion criteria, findings show that within this sample population there was substantial variability across sites in terms of types of trauma exposure, types of drugs used and specific drug use diagnoses. • Despite such 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. • Although SUD outcomes were not statistically significant by the end of six weeks of treatment, they were reduced from baseline and the number of sessions received did significantly predict lowered levels of SUD symptoms. • We speculate that the reductions observed in PTSD symptoms during treatment, particularly in the SS group, may be more pronounced over the follow up period and lead to greater reductions in SUD symptoms over time.

  37. Frankie Kropp Agatha Kulaga Melissa Gordon Chanda Brown Silvia Mestre Nadja Schreiber Mary Hatch-Maillette Chris Neuenfeldt Cheri Hansen Karen Esposito Sharon Chambers Project Directors/Protocol PIs

  38. Brianne O’Sullivan Ileana Graf Melissa Chu Nishi Kanukollu Treneane Salisbury Rebecca Krebs Ann Whetzel Stella Resko Carol Hutchinson Chanda Brown Janice Ayuda Pamela Bernard Jessica Ucha Nicole Moodie Allison Kristman-Valente Lynette Wright Melanie Spear Lisa Johnson Catherine Williams Calonie Gray Michele DiBono Rachel Hayon Barbara Bettini Barbara Thomas Lisa Markiewicz Elizabeth Cowper Rosaline King Lara Reichert CTN-0015 Research Staff

  39. Lisa Cohen Dawn Baird-Taylor Lisa Litt Martha Schmitz Karen Tozzi Darlene Franklin Kathleen Estlund Molly McHenry-Whalen Erin Demirjian Anslie Stark Karen Bowes Metris Batts Felisha Lyons Kathy McPherson Victoria Johnson Denese Lewis Sharon Anderson-Goss Merilee Perrine Angela Waldrop Leslie Lobel-Juba Maria Mercedes Giol Lourdes Barrios Lisa Mandelman Jeanette Suarez Danielle Macri Maria Hurtado Tina Klem Nancy Magnetti Anne Marie Sales Renee Sumpter Michelle Melendez Ida Landers Regina Morrison Clare Tyson Mary Hodge-Moen Sandra Free Goldie Galloway Karen Canida Katie Revenaugh CTN-0015 Clinicians

  40. Jim Robinson JP Noonan Connie Klein Karen Loncto Chris Hutz Lauren Fine Michelle Cordner Melissa Gordon Maura Weber Kristie Smith Catherine Dillon Donna Bargoil Jurine Lewis Girish Gurnani Inna Logvinsky Peggy Somoza Sharon Pickrel Katie Weaver Molly Carney Catherine Otto Rebecca Defevers Emily DeGarmo Royce Sampson Stephanie Gentilin Clare Tyson Anthony Floyd Nathilee Francois CTN-0015 QA and Data Management

  41. Appendices: Summary Data Tables

  42. Comparison of Existing Trauma / SUD- Focused Treatment Research

  43. Summary Statistics for Post-treatment PSS-SR Severity Modeled by Baseline PTSD Severity, Demographics, Treatment Group, Time, Site, and their Interactions

  44. Summary Statistics for Post-treatment PSS-SR Frequency Modeled by Baseline PTSD Frequency, Demographics, Treatment Group, Time, Site, and their Interactions

  45. Summary Statistics for Post-treatment Days of Use Modeled by Baseline Days of Use, Demographics, Treatment Group, Time, Site, and their Interactions

  46. Summary Statistics for Post-treatment Abstinence Rates Modeled by Baseline Abstinence, Demographics, Treatment Group, Time, Site, and their Interactions

More Related