Early findings from NIDA

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Early findings from NIDAs Clinical Trials
Network Women and Trauma Study

• Denise Hien, Ph.D.
• Senior 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
• 115th Annual American Psychological Association
  Meeting
• San Francisco, California
• August 18, 2007
• PLEASE DO NOT CITE CONTENTS OF PRESENTATION
  WITHOUT PERMISSION OF THE AUTHOR

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• The past isnt dead, it isnt even past.
• -William Faulkner

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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)

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Neurobiological 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)

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Historical 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
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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
Hermans Trauma and Recovery published
1990 1995 2000 2007
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
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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

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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/ARTS Substance Dependence PTSD
  Therapy/Assisted Recovery from Trauma and
  Substances (Triffleman et. al, 1999)

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NIDA 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
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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
• David Liu, NIDA Liaison

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Participating Nodes and CTPs
Node Node PI(s) Protocol PI CTP Site PI Location
Florida Jose Szapocznik Daniel Santisteban Lourdes Suarez-Morales The Village Michael Miller Miami, FL
Florida Jose Szapocznik Daniel Santisteban Lourdes Suarez-Morales 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 Research Treatment 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 Wells Betsy Wells Residence XII Karen Canida Kirkland, WA
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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

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Study 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.

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Pre-Post Control Group Design
Pre-screening, 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
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Treatment 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

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Seeking 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
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Womens 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)

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Assessment Domains (1 of 2)

• Demographics
• Substance Use Disorder 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)

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Assessment Domains (2 of 2)

• 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 Non-study mental health,
  medical, substance abuse treatment services

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In-Treatment Measures(baseline, weekly thru
treatment,1 week 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)
• Service Utilization (NSMS)
• Medication (ASL)
• Adverse Events (AE)

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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

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Enrollment
Initial Eligibility Screen N1,963
Ineligible N751
Eligible for Full Screen N1,212 (62)
No/Incomplete Screen N671
Completed Screen N541 (45)
Ineligible N162
Completed Baseline Eligible for
Randomization N379 (70)
Not Randomized N26
Randomized N353 (93)
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Sample Characteristics (N353)
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PTSD Diagnosis and Severity at Baseline (N353)
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Substance Use Disorders at Baseline (N353)
Note not exclusive categories
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Lifetime Trauma Exposure (N353)
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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-occurr
  ing wait list controls was examined with
  baseline as the pre-test and assessment during
  1st week of treatment as the post-test.
• Analyses addressing impact of treatment
  attendance on outcomes were conducted.
• Between group comparisons of service utilization,
  medication, and adverse events were conducted.

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Modeled PSS-SR Severity during Treatment
Mean Severity
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Modeled PSS-SR Frequency during Treatment
Mean Frequency
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Modeled Abstinence Rate during Treatment
Abstinent
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Modeled Days of Use during Treatment (past 7 days)
Days of Use ()
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Secondary Analyses Six Week Pre- Post Changes
for Non-Randomized Naturalistic Wait Group (N20)
Mean Severity
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Secondary Analyses Treatment Attendance Rates
Treatment Group N Mean (sd) Median
SS 170 6.3 (4.4) 7
WHE 172 5.9 (4.3) 6.5
No significant differences between groups
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Secondary Analyses Effects of treatment
attendance on post-treatment abstinence rates
Source DF ?2 p-value
Baseline Abstinence 1 48.07 lt.001
Race 3 2.39 n.s.
Site 5 48.95 lt.001
Age 1 0.27 n.s.
Education 1 0.00 n.s.
Time 1 4.33 lt.05
Treatment 1 0.04 n.s.
Treatment Attendance 1 7.47 lt.001
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Secondary Analyses Effects of treatment
attendance on post-treatment days of use
Source DF ?2 p-value
Baseline Use 1 24.09 lt.001
Race 3 1.48 n.s.
Site 5 14.20 0.01
Age 1 0.85 n.s.
Education 1 1.28 n.s.
Time 6 11.78 n.s.
Treatment 1 0.05 n.s.
Baseline UseTime 6 24.89 lt.001
Treatment Attendance 1 7.07 lt.01
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Service Utilization
Baseline Treatment Treatment
Service Receiving Receiving Visits/Week M (SD)
Mental Health SS WHE 73.7 80.7 83.8 78.9 1.30 (1.6) 1.50 (2.7)
Outpatient Medical SS WHE 49.7 48.3 62.7 58.3 0.20 (0.5) 0.20 (0.4)
Inpatient Drug Treatment ( nights) SS WHE 20.0 14.8 3.5 4.5 0.04 (0.4) 0.05 (0.3)
ER/Hospital SS WHE 18.9 17.7 24.7 32.7 0.04 (0.1) 0.05 (0.1)
12-Step Meeting SS WHE 76.0 72.3 83.1 81.4 3.40 (4.1) 2.80 (3.7)
Total SS WHE 91.4 93.2 97.9 95.5 5.00 (5.3) 4.60 (6.0)
Service use data collected in visits unless
otherwise noted no differences between SS and
WHE on any variable
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Medication (past 30 days)
Baseline Post Treatment

Prescribed for Psychiatric Problems SS WHE 42.6 40.1 46.3 31.3
p-value 0.63 0.02
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Adverse Events during Treatment
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Adverse Event Descriptions
Frequency
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Summary

• Despite a number of 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.
• Those in Seeking Safety groups improved
  significantly more quickly on PTSD symptoms over
  the course of six weeks of treatment.
• The number of sessions received significantly
  predict lowered levels of SUD symptoms, as did
  baseline severity of use.
• Although participants in both groups experienced
  study related adverse events, there were no
  differences in rates between groups, and further,
  these did not impact treatment attendance or
  post-treatment outcomes.
• Utilization of other services including
  outpatient drug and mental health visits, twelve
  step meetings, medical visits and
  hospitalizations did not differ across treatment
  groups.

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Implications

• With supervision, counselors in drug treatment
  programs can be trained to conduct and deliver
  Seeking Safety and Womens Health groups safely.
• Consideration of the impact of trauma-focused
  assessments should also be given in the treatment
  process all participants received weekly
  self-reported assessments of their symptoms.
• Being assigned to a group with other women who
  have been identified as having trauma or PTSD may
  also have a powerful effect on expectancies and
  outcomes, as those in Womens Health also
  improved significantly on PTSD symptoms.
• Longer-term groups and additional approaches may
  be needed to impact substance use and abuse.

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THANK YOU!

• 353 Women who participated in the study
• 28 Research Assistants, Assessors, and
  Coordinators
• 39 Therapists and Supervisors
• 11 Project Directors and Protocol Principal
  Investigators
• 27 Quality Assurance Monitors and Data Managers
• NIDA U10DA13035

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• Appendices Summary Data Tables

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Comparison of Existing Trauma / SUD- Focused
Treatment Research
Najavits, 1998 Triffleman, 2000 Brady et. al., 2001 Donovan, 2001 Hien et al., 2004
N 27 Women 19 Mixed 39 Mixed 46 Men 107 Women
Design No Control RCT No Control No Control RCT
Sessions, Timeframe Modality 24, 3 mos., group 40, 5 mos., individual 16 4 mos., individual 60 3 mos., group 24 3 mos., individual
Tx Content SS SDPT, 12-Step CTPSD, CBT, Exposure CBT, RPT, Soc Support SS, RPT, TAU
Follow Up 3 mos. 1 mo. 6 mos. 6/12 mos. 6/9 mos.
Results ? SU, PTSD Depression SXs ? SU, PTSD, Psych SXs ? SU, PTSD Depression SXs ? SU, PTSD SXs ? SU, PTSD, Psych SXs at 6 mos
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Summary Statistics for Post-treatment PSS-SR
Severity Modeled by Baseline PTSD Severity,
Demographics, Treatment Group, Time, Site, and
their Interactions
Parameter DF ?2 p-value
PSS-SR Baseline 1 71.73 lt.001
Race 3 1.34 n.s.
Site 5 24.19 lt.001
Age 1 0.68 n.s.
Education 1 4.97 lt.05
Time 1 1.08 n.s.
Treatment 1 6.81 lt.01
TimeTreatment 1 4.96 lt.05
Time PSS-SR Baseline 1 12.35 lt.001
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Summary Statistics for Post-treatment PSS-SR
Frequency Modeled by Baseline PTSD Frequency,
Demographics, Treatment Group, Time, Site, and
their Interactions
Parameter DF ?2 p-value
PSS-SR Baseline 1 76.74 lt.001
Race 3 0.64 n.s.
Site 5 27.60 lt.001
Age 1 0.95 n.s.
Education 1 5.07 lt.05
Time 1 1.47 n.s.
Treatment 1 8.55 lt.01
TimeTreatment 1 5.28 lt.05
Time PSS-SR Baseline 1 15.32 lt.001
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Summary Statistics for Post-treatment Days of Use
Modeled by Baseline Days of Use, Demographics,
Treatment Group, Time, Site, and their
Interactions
Parameter DF ?2 p-value
Baseline Days of Use 1 21.66 lt.001
Race 3 1.26 n.s.
Site 5 18.37 lt.01
Age 1 0.50 n.s.
Education 1 0.95 n.s.
Time 6 11.90 lt.10
Treatment 1 0.01 n.s.
Baseline Days of UseTime 6 20.80 lt.01
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Summary Statistics for Post-treatment Abstinence
Rates Modeled by Baseline Abstinence,
Demographics, Treatment Group, Time, Site, and
their Interactions
Parameter DF ?2 p-value
Baseline Abstinence 1 51.12 lt.001
Race 3 2.10 n.s.
Site 5 44.18 lt.001
Age 1 0.18 n.s.
Education 1 0.00 n.s.
Time 1 0.02 n.s.
Treatment 1 0.12 n.s.