Title: CTN 0015: Preliminary findings from the Women and Trauma Study
1CTN 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, Womens Health Project
Treatment and Research Center, Addiction
Institute of New York, St. Lukes\Roosevelt
Hospital Center - St. Petersburg, Florida
- December 7, 2006
- PLEASE DO NOT CITE CONTENTS OF PRESENTATION
WITHOUT PERMISSION OF THE AUTHOR
2- The past isnt dead, it isnt even past.
- -William Faulkner
3Scope 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)
4Neurobiological 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)
5Historical Context for the Study of Trauma
Addiction
Womens movement and grassroots advocacy for
battered women
Crack/ Cocaine epidemic
Fulliloves snowball sample
1970 1980 1990
PTSD studies with male veterans with/out
substance use
DSM-IIIR broadens criteria for PTSD
Millers work with criminal justice population
6Historical 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
Hermans 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
7Differences 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
8PTSD/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)
9NIDA Clinical Trials Network Women Trauma Sites
Washington Node Residence XII
New England Node LMG Programs
Ohio Valley Node Maryhaven
New York Node ARTC
Long Island Node Lead Node
South Carolina Node Charleston Center
Florida Node Gateway Community
Florida Node The Village
10CTN 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
11Participating Nodes and CTPs
12CTN 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
13Study Aims
- To assess the effectiveness of adding Seeking
Safety (SS) and Womens 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.
14Pre-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
15Treatment Groups
- Seeking Safety (SS)
- Short term, manualized treatment
- Cognitive Behavioral
- Focused on addiction and trauma
- Womens Health Education (WHE)
- Short term, manualized treatment
- Psychoeducational
- Focused on womens health information and issues
16Seeking Safety
- Developed as a group treatment for PTSD/SUD women
- Based on CBT models of SUDs, PTSD treatment,
womens treatment and educational research - Educates patients about PTSD and SUDs 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
17Womens 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)
18Assessment 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)
19Assessment 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)
20In-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)
21Participant 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
22Enrollment
Initial Screen N1,963
Ineligible N751
Eligible for Baseline N1,212 (62)
No Full Screen N751
Completed Baseline N541 (45)
Ineligible N162
Eligible for Randomization N379 (70)
Not Randomized (multiple reasons) N26
Randomized N353 (93)
23Sample Characteristics (N353)
24PTSD Diagnosis and Severity at Baseline (N353)
25Substance Use Disorders at Baseline (N353)
Note not exclusive categories
26Lifetime Trauma Exposure (N353)
27Data 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-occurr
ing 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.
28PTSD In-Treatment Outcomes PSS-SR severity
modeled from pre-treatment to post-treatment
weekly by treatment group
29PTSD In-Treatment Outcomes PSS-SR frequency
modeled from pre-treatment to post-treatment
weekly by treatment group
30SUD In-Treatment Outcomes Abstinence rates
modeled from pre-treatment to post-treatment
weekly by treatment group
31SUD In-Treatment Outcomes Days of use modeled
from pre-treatment to post-treatment weekly by
treatment group
32Secondary Analyses Six Week Pre- Post Changes
for Non-Randomized Naturalistic Wait Group (N20)
Wait List
33Secondary Analyses Treatment Attendance Rates
No significant differences between groups
34Secondary Analyses Effects of treatment
attendance on post-treatment abstinence rates
35Secondary Analyses Effects of treatment
attendance on post-treatment days of use
36Comments
- 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(No Transcript)
38Project Directors/Protocol PIs
- Frankie Kropp
- Agatha Kulaga
- Melissa Gordon
- Chanda Brown
- Silvia Mestre
- Nadja Schreiber
- Mary Hatch-Maillette
- Chris Neuenfeldt
- Cheri Hansen
- Karen Esposito
- Sharon Chambers
39CTN-0015 Research Staff
- Brianne OSullivan
- 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
40CTN-0015 Clinicians
- 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
41CTN-0015 QA and Data Management
- 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
42- Appendices Summary Data Tables
43Comparison of Existing Trauma / SUD- Focused
Treatment Research
44Summary Statistics for Post-treatment PSS-SR
Severity Modeled by Baseline PTSD Severity,
Demographics, Treatment Group, Time, Site, and
their Interactions
45Summary Statistics for Post-treatment PSS-SR
Frequency Modeled by Baseline PTSD Frequency,
Demographics, Treatment Group, Time, Site, and
their Interactions
46Summary Statistics for Post-treatment Days of Use
Modeled by Baseline Days of Use, Demographics,
Treatment Group, Time, Site, and their
Interactions
47Summary Statistics for Post-treatment Abstinence
Rates Modeled by Baseline Abstinence,
Demographics, Treatment Group, Time, Site, and
their Interactions