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Synthesizing Outcomes In
Evidence-based Practices For
Women With Trauma and
Addictions
Denise Hien, Ph.D., ABPP
City University of New York, Subprogram in Clinical Psychology &
Columbia University College of Physicians & Surgeons
Gloria Miele, Ph.D.
Columbia University College of Physicians and Surgeons
Aimee Campbell, Ph.D., MSW
New York State Psychiatric Institute, Columbia University College of Physicians and
Surgeons; St. Luke’s Roosevelt Hospital Center
College on Problems of Drug Dependence Annual Meeting
June 20, 2013
This work was supported by the National Institute on Drug Abuse: U10DA13035 (PI: Nunes), DA01025198
(PI: Morgan-Lopez), and City College Interdisciplinary Research Program (PI: Hien)
PTSD-SUD Treatment Questions
Can we reduce PTSD symptoms
without increasing substance use?
Can we safely deliver
trauma-focused group
therapy in community
based drug treatment?
Study Team
Participating Sites
CTN Node
FL
Lead Investigative Team
Denise Hien, Lead Investigator
Edward Nunes, Node PI
Gloria Miele, Training Director
Lisa Cohen, Protocol Manager
Aimee Campbell, Proj Director
Jennifer Lima, Node Coord
Huiping Jiang, Statistician
Mei-Chen Hu, Statistician
David Liu, NIDA Liaison
Site Investigators
Program
Lourdes Suarez-Morales The Village
Michael Miller
Gateway
Candace Hodgkins
New
England
Melissa Gordon
Sam Ball
LMG
Programs
NY
Marion Schwartz
Robert Sage
ARTC
OH
Valley
Greg Brigham
Maryhaven
SC
Therese Killeen
Mark Cowell
Charleston
Center
WA
Betsy Wells
Karen Canida
Residence
XII
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 12session group version of Seeking Safety in
community drug/alcohol treatment settings.
 Secondary Analyses:
 To identify for whom and how the trauma
focused therapy worked best.
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 issues
Pre-Post Control Group Design
Pre-Treatment
1 - 4 Weeks
Treatment
6 Weeks
Post
Treatment
Follow-up
46 Weeks
Screening, Baseline,
Randomization,
Individual Session w/ Counselor
12 Twice Weekly Group
Sessions (rolling admission)
1
Week
3
Month
6
Month
12
Month
PSS-SR Trauma Symptom Severity
for ITT Sample (N=353)
Hien, Wells, 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.
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.
Snapshot of
Secondary Analyses:
For Whom, In What
Ways and In What
Context?
Subgroups
Other Outcomes
Mediators and Moderators
Alcohol Misuse
SS had stronger
treatment effects on
PTSD hyperarousal
symptoms (PSS-SR)
compared with WHE
over time for women
with alcohol misuse at
baseline.
Hien, Campbell et al. (2010). 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.
Cocaine/Stimulant Use
14
12
10
Women's Heal t h
E ducat i on
8
Seeki ng Saf et y
6
4
2
0
Baseline
1-week f ollow-up
3-mont h f ollow-up
6-mont h f ollow-up
12-mont h f olllow-up
Days of cocaine/stimulant use in the last 30 days (N=141)
Ruglass, Hien, Hu, & Campbell, AN. (In press). Secondary analysis of outcomes for stimulant users with PTSD in the NIDA “Women
and Trauma” study. American Journal on Addictions
Snapshot of
Secondary Analyses:
In What Ways?
Subgroups
Other Outcomes
Mediators and Moderators
Sexual Risk
Participants
receiving SS who
were at higher risk
significantly reduced
unprotected sexual
occasions over 12month follow-up.
Hien et al. (2009). The impact of trauma-focused group therapy upon HIV risk behaviors among women with PTSD in the NIDA
Clinical Trials Network “Women and Trauma.” AIDS and Behavior.
Eating Disorders
Presence of eating
disorders at
baseline led to
significantly less
improvement in
PTSD symptoms
and abstinence
over time.
Cohen et al. (2010). Eating disorders and trauma among female substance use disorders: Is there a real association? A secondary
analysis of NIDA’s CTN “Women and Trauma” multi-site trial. American Journal on Addictions.
Other Positive Outcomes
Alliance
Safety
Ruglass et al., 2012
Killeen et al., 2008
Trajectories
of Change
Attrition/
Retention
Lopez-Castro et al., 2012
Resko et al., 2012
Pinto et al., 2011
Intimate
Partner
Violence
Sleep
Disorders
Cohen et al, 2013
McHugh et al, 2013
Snapshot of
Secondary Analyses:
In What Context?
Subgroups
Other Outcomes
Mediators and Moderators
Racial/Ethnic Matching
White clients with more severe
PTSD at baseline improved on
PTSD outcomes when
receiving SS from a ethnicallymatched White therapist
African-American and Latino
clients with less SUD severity
at baseline improved on SUD
outcomes with SS if they had
an ethnically-matched nonWhite therapist
Temporality of Treatment
Response
Improvement To
1
2
3
4
5
None
Drug Use
PTSD
Symptoms
Global
Drop
Out
1
None
0.503
0.208
0.087
0.062
0.140
2
Drug Use
0.111
0.656
0.016
0.131
0.085
3
PTSD
0.149
0.081
0.310
0.367
0.093
4
Global
0.026
0.161
0.060
0.692
0.062
Improvement From
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.
A Conceptual Model for How
PTSD Affects Alcohol Use
Central Nervous
System
Depressants
Hyper-arousal
Symptoms of
PTSD
Alcohol
Withdrawal
Symptoms
A Mediational Model of PTSD Severity
and Alcohol Use
PTSD Severity
b = -.03, p<.05
b = 16.27, p<.01
Mediated effect
-.66 (CI: -1.59,-.125)
Seeking Safety
Alcohol Use
Morgan-Lopez, Saavedra, Hien, et al. (In press). Indirect Effects of Seeking Safety on Substance Use Outcomes: Overall and
Attendance Class-Specific Effects. American Journal on Addictions
Attendance Matters
Three distinct attendance
patterns emerged:
Completers, Droppers, and
Titrators.
Titrators in Seeking Safety
had lower rates of alcohol
use across the study period
compared to the health
education control; cocaine
results were similar but not
statistically significant.
Hien, Morgan-Lopez, et al. (2012) Can Less be More?: A secondary analysis of CTN “Women and Trauma” study.
Journal of Consulting and Clinical Psychology.
Alcohol Use Over Time For AA Attenders
Predicted Probability of Alcohol Use (ASI-Lite)
60
50
40
WHE
30
SS
20
10
0
Baseline
1-wk FU
3m FU
6m FU
12m FU
Time
Morgan-Lopez, Hien, et al. (in press). Synergistic effects of recovery management: A secondary analysis of the NIDA Clinical
Trials Network “Women and Trauma” study. Journal of Substance Abuse Treatment.
Alcohol Use Over Time For Non-AA
Attenders
120
Predicted Probability of Alcohol Use
100
80
WHE
60
SS
40
20
0
Baseline
1-wk FU
3m FU
6m FU
12m FU
Time
Morgan-Lopez, Hien, et al. (in press). Synergistic effects of recovery management: A secondary analysis of the NIDA Clinical
Trials Network “Women and Trauma” study. Journal of Substance Abuse Treatment.
Considerations Regarding
Secondary Analyses
• Large enough sample size to examine
nuanced clinical questions yielding promising
avenues for future inquiry
• Cautions regarding over interpretation of
findings
Patients with more severe problems
benefited most from the specialty trauma
treatment
Those with in-treatment PTSD reductions
showed greatest substance abuse
improvements
Findings support that
community providers can do
trauma groups effectively and
safely
Understanding
contextual factors is
critical to matching
trauma therapies to
patients
Hands on guide for
clinicians and providers
seeking to treat women
who suffer from trauma
and the effects of
substance abuse
Available from APA
Press and on
Amazon.com
THANK YOU
Participants & Staff from NIDA CTN “Women & Trauma”
 353 Participants; 28 RAs, Assessors, & Coordinators; 39
Therapists & Supervisors; 11 Project Directors and
Protocol Principal Investigators; 27 QA Monitors and
Data Managers
Colleagues & Students
 Violet Amata; Raquel Bibi; Ruthie Bornstein; Nathilee
Caldeira PhD; Aimee Campbell PhD; Lisa Cohen PhD;
Eric Fertuck PhD; Eva Garcia; Miriam Hafez; Grace
Kiriakos; Peter Lemons; Lisa Litt PhD; Jed McGiffin;
Robert Melara PhD; Antonio Morgan-Lopez PhD; Gloria
Miele PhD; Edward Nunes MD; Lesia Ruglass PhD;
Lissette Saavedra PhD; Rafal Skiba; & Patricia Yoon
Funding Support
 U10DA13035 (PI: Nunes); DA01025198 (PI: MorganLopez); & City College City Seeds Interdisciplinary Grant
(PI: Hien)