Effective Effective Treatments for Treatments for PTSD in Women PTSD in Women

with SUDwith SUDDenise Hien, Ph.D., dhien@ccny.cuny.eduProfessor and Adjunct Senior Research ScientistCity University of New York, Subprogram in Clinical Psychology & Columbia University College of Physicians & Surgeons

138th American Public Health Association Annual MeetingNovember 10, 2010 | Denver, Colorado

Presenter DisclosuresPresenter Disclosures

(1)(1) The following personal financial relationships with The following personal financial relationships with commercial interests relevant to this presentation commercial interests relevant to this presentation existed during the past 12 months:existed during the past 12 months:

Denise Hien, Ph.D.

No relationships to disclose

Scope: Trauma and Scope: Trauma and AddictionAddiction

1 in 2 women in the U.S. experience 1 in 2 women in the U.S. experience some type of traumatic event some type of traumatic event (Kessler, (Kessler, 1995)1995)

Approximately 33% of females Approximately 33% of females under ageunder age 18 experience sexual 18 experience sexual abuse abuse (Finkelhor, 1994; Wyatt, 1999)(Finkelhor, 1994; Wyatt, 1999)

20% to 65% of individuals in 20% to 65% of individuals in treatment for SUD reporting assault treatment for SUD reporting assault histories histories (G. R. Brown & Anderson, 1991; P. J. Brown et (G. R. Brown & Anderson, 1991; P. J. Brown et al., 1995)al., 1995)

Prevalence rates of PTSD in Prevalence rates of PTSD in community samples have ranged community samples have ranged from 6% to 36% from 6% to 36% (Breslau, 1991; Kilpatrick, 1987; (Breslau, 1991; Kilpatrick, 1987; Norris, 1992; Resnick, 1993)Norris, 1992; Resnick, 1993)

Studies have documented PTSD Studies have documented PTSD rates among substance using rates among substance using populations to be between 14%-populations to be between 14%-60%60% (Brady, 2001; Donovan, 2001; Najavits, 1997; (Brady, 2001; Donovan, 2001; Najavits, 1997;

Triffleman, 2003)Triffleman, 2003)

Pandora, the first woman, Pandora, the first woman, created by the God of Fire created by the God of Fire and endowed with many and endowed with many gifts, was treacherously gifts, was treacherously presented with a box presented with a box containing the evils of containing the evils of humankind. When a humankind. When a naturally curious Pandora naturally curious Pandora opens the box, the evils opens the box, the evils escape.escape.

Realizing what has Realizing what has happened, Pandora happened, Pandora struggles to close the box, struggles to close the box, able to do so in time to able to do so in time to keep Hope from escaping.keep Hope from escaping.

Pandora Problem

Phases of Trauma Phases of Trauma TreatmentTreatment

Stabilize Process

Affect Regulation

Distress Tolerance

Somatosensory

Exposure

Cognitive

Combined Behavioral Combined Behavioral Treatments for Trauma Treatments for Trauma

and Addictions and Addictions ARTSARTS: Assisted Recovery from Trauma : Assisted Recovery from Trauma and Substancesand Substances (Triffleman et. al, 1999)(Triffleman et. al, 1999)

ATRIUMATRIUM: Addictions and Trauma : Addictions and Trauma Recovery Integrated ModelRecovery Integrated Model (Miller & Guidry, (Miller & Guidry, 2001)2001)

COPECOPE: Concurrent Treatment with : Concurrent Treatment with Prolonged Exposure Prolonged Exposure (Back and Kileen, in (Back and Kileen, in

development)development) CBT for PTSD CBT for PTSD (McGovern, in development)(McGovern, in development)

Seeking SafetySeeking Safety (Najavits, 1998; (Najavits, 1998; www.seekingsafety.org)www.seekingsafety.org)

TranscendTranscend (Donovan et al., 2001)(Donovan et al., 2001)

Overall Summary of Overall Summary of Trauma/SUD Trauma/SUD

Psychotherapy StudiesPsychotherapy StudiesCBT shows CBT shows promisepromise in treating PTSD/SUD in treating PTSD/SUD

PTSD treatments PTSD treatments did not make patients did not make patients worseworse, and improved PTSD, substance , and improved PTSD, substance use and general psychiatric symptomsuse and general psychiatric symptoms

Integrated counselingIntegrated counseling may be one of the may be one of the key program features that impacts key program features that impacts outcomes.outcomes.

More research needed to examine More research needed to examine the the duration, scope, timing and combination duration, scope, timing and combination of componentsof components to identify optimal model to identify optimal model of PTSD/SUD treatment integrationof PTSD/SUD treatment integration

Limits of Randomized Limits of Randomized Controlled Trials for Controlled Trials for

Patients with PTSD/SUDPatients with PTSD/SUDRestricted participant characteristicsRestricted participant characteristics

Heterogeneity in diagnosis and concurrent Heterogeneity in diagnosis and concurrent treatmenttreatment

Inflexible treatment implementationInflexible treatment implementationPractical guidelines regarding participant Practical guidelines regarding participant treatment participationtreatment participation

Therapist characteristics and training that Therapist characteristics and training that do not reflect community practitionersdo not reflect community practitioners

Using community clinicians in a train-the-Using community clinicians in a train-the-trainer modeltrainer 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.

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 NIDA Clinical Trials Network Trauma Group Study SitesTrauma Group Study Sites

CTN Long Island CTN Long Island Node TeamNode Team

Denise Hien, Lead Denise Hien, Lead InvestigatorInvestigator

Edward Nunes, Node PIEdward Nunes, Node PI

Gloria Miele, Training DirectorGloria Miele, Training Director

Lisa Cohen, Protocol ManagerLisa Cohen, Protocol Manager

Aimee Campbell, Project Aimee Campbell, Project DirectorDirector

Jennifer Lima, Node Jennifer Lima, Node CoordinatorCoordinator

Huiping Jiang, StatisticianHuiping Jiang, Statistician

Mei-Chen Hu, Statistician Mei-Chen Hu, Statistician

David Liu, NIDA LiaisonDavid Liu, NIDA Liaison

Participating Nodes and CTPsNode Node PI(s) Protocol PI CTP Site PI Location

Florida

Jose Szapocznik & Daniel Santisteban

Lourdes Suarez-Morales

The VillageMichael Miller

Miami, FL

Gateway Community

Candace Hodgkins

Jacksonville, FL

New England

Kathleen Carroll

Melissa Gordon

LMG Programs Samuel BallStamford, CT

New York John RotrosenMarion Schwartz

Addiction Res & TX Corporation

Robert SageBrooklyn, NY

Ohio Valley Gene SomozaGreg Brigham

MaryhavenGreg Brigham

Columbus, OH

South Carolina

Kathleen Brady

Therese Killeen

Charleston Center

Mark CowellCharleston, SC

WashingtonDennis Donovan

Betsy Wells Residence XII Karen CanidaKirkland, WA

Study AimsStudy Aims

Primary Analyses:Primary Analyses:To assess the To assess the effectivenesseffectiveness of adding a of adding a trauma focused therapy to ongoing trauma focused therapy to ongoing substance abuse treatment.substance abuse treatment.To evaluate the transportability of a To evaluate the transportability of a 12- session group version of SS in 12- session group version of SS in community drug/alcohol treatment community drug/alcohol treatment settings.settings.

Secondary Analyses:Secondary Analyses:To identify for whom and how the To identify for whom and how the trauma focused therapy worked best.trauma focused therapy worked best.

Treatment Treatment GroupsGroups

Seeking Safety (SS)Seeking Safety (SS)Short term, manualized treatmentShort term, manualized treatmentCognitive BehavioralCognitive BehavioralFocused on addiction and traumaFocused on addiction and trauma

Women’s Health Education (WHE)Women’s Health Education (WHE)Short term, manualized treatmentShort term, manualized treatmentPsychoeducationalPsychoeducationalFocused on women’s health info Focused on women’s health info and issuesand issues

Pre-Post Control Pre-Post Control Group DesignGroup 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)

Assessment Assessment MeasuresMeasures

PTSD symptomsPTSD symptomsPTSD Symptom Scale- Self-Report (PSS-SR)PTSD Symptom Scale- Self-Report (PSS-SR)

Clinician Administered PTSD Scale (CAPS)Clinician Administered PTSD Scale (CAPS)

Substance use symptomsSubstance use symptomsSubstance Use Inventory (SUI)Substance Use Inventory (SUI)

Addiction Severity Index (ASI)Addiction Severity Index (ASI)

Alcohol CompositeAlcohol CompositeDrug CompositeDrug CompositeMaximum number of days of useMaximum number of days of use

Study EnrollmentStudy Enrollment

Initial Eligibility ScreenN=1,963

Screening N=541

Baseline N=370

Randomized N=353

IneligibleN=751 (38%)

No-show to Screen N=671 (34%)

Ineligiblen=171 (32%)

Not Randomized N=17 (5%)

Sample Sample Characteristics Characteristics

(N=353)(N=353)Variable % or M (SD)

Age (years) 39.2 (9.3) Race/ethnicity

Hispanic or Latina 6.5 Black/African American 34.0

White 45.6 Mixed 13.3 Other 0.6

Marital status Married 33.3

Widowed/Divorced 29.3 Never Married 37.4

Education Years 12.5 (2.4)

Baseline PTSD Severity Baseline PTSD Severity (N=353)(N=353)

Variable percent or M (S.D.) PTSD Diagnosis

Full Subthreshold

80.4 19.6

CAPS Total Score 62.8 (19.4)

PSS-SR Severity 45.6 (10.8)

PSS-SR Frequency 38.7 (15.3)

Baseline Substance Use Baseline Substance Use Disorders Disorders (N=353)(N=353)

Current Substance Use Diagnosis percent

Alcohol 62.0

Marijuana 35.4

Opiates 33.1

Cocaine 72.8

Stimulant 8.2

Note: not exclusive categories

PSS-SR Trauma Symptom PSS-SR Trauma Symptom Severity for ITT Sample Severity for ITT Sample

(N=353)(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.

Abstinence Rates for ITT Abstinence Rates for ITT Sample (N=353)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.

Examining Examining Functional Functional

Relationships is Relationships is CriticalCritical

to understanding how and for to understanding how and for whom the trauma treatments whom the trauma treatments

work bestwork best

Temporality of Treatment Temporality of Treatment ResponseResponse

Improvement To

1 2 3 4 5

Improvement FromNone Drug Use

PTSD Symptoms

GlobalDrop Out

1None 0.503 0.208 0.087 0.062 0.140

2Drug Use 0.111 0.656 0.016 0.131 0.085

3PTSD 0.149 0.081 0.310 0.367 0.093

4Global 0.026 0.161 0.060 0.692 0.062

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.

Alcohol MisuseAlcohol MisuseStronger Stronger Seeking SafetySeeking Safety treatment treatment effects on PTSD effects on PTSD hyperarousal hyperarousal symptoms (PSS-symptoms (PSS-SR) compared SR) compared with with WHEWHE over over time were found time were found for women with for women with alcohol misuse alcohol misuse at baseline.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

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

SummarySummaryPTSD changes found to impact SUD outcomePTSD changes found to impact SUD outcome/ No / No evidence substance use reduction improved PTSD. evidence substance use reduction improved PTSD.

Findings of all analyses consistent with a Findings of all analyses consistent with a self-medication self-medication model model of coping with PTSD.of coping with PTSD.

Addressing trauma related symptoms did not negatively Addressing trauma related symptoms did not negatively impact substance use recovery. impact substance use recovery. Instead trauma-focused Instead trauma-focused treatment can lead to improvements in SUD outcomes treatment can lead to improvements in SUD outcomes in in the context of PTSD symptom reduction.the context of PTSD symptom reduction.

Clinicians working with Clinicians working with alcohol misusers should attend alcohol misusers should attend to hyperarousal; those with cocaine/stimulant users may to hyperarousal; those with cocaine/stimulant users may want to pay attention to avoidance/numbing cluster want to pay attention to avoidance/numbing cluster throughout treatment.throughout treatment.

Empirical basis Empirical basis for recommending PTSD-focused and for recommending PTSD-focused and integrated interventions for improved substance use integrated interventions for improved substance use outcomes in patients outcomes in patients with severe symptoms.with severe symptoms.

Attendance patterns and other contextual factors are Attendance patterns and other contextual factors are importantimportant to consider in evaluating treatment outcomes. to consider in evaluating treatment outcomes.

Implications for Implications for DisseminationDissemination

• In order for psychotherapy research studies In order for psychotherapy research studies to inform and deepen our understanding of to inform and deepen our understanding of treatment treatment andand be relevant to the be relevant to the community, we must consider:community, we must consider:

• What are meaningful outcomes that tell What are meaningful outcomes that tell us us whetherwhether and and howhow theories of theories of psychotherapy map onto reality?psychotherapy map onto reality?

• Transdisciplinary approaches.Transdisciplinary approaches.• Integrating mind/body: Physical Health, STD and HIV Integrating mind/body: Physical Health, STD and HIV • PharmacotherapiesPharmacotherapies• Multimedia interventions for a wider audienceMultimedia interventions for a wider audience

• Need novel designs, innovative statistical Need novel designs, innovative statistical methods, and broader yet more systematic methods, and broader yet more systematic criteria.criteria.

Available from Available from APA PressAPA Press

Hands on guide Hands on guide for clinicians for clinicians and providers and providers seeking to treat seeking to treat women who women who suffer from suffer from trauma and the trauma and the effects of effects of substance substance abuseabuse

THANK YOU!THANK YOU!

Participants and staff on the NIDA CTN Study:Participants and staff on the NIDA CTN Study:

353 Participants; 28 Research Assistants, 353 Participants; 28 Research Assistants, Assessors, and Coordinators; 39 Therapists Assessors, and Coordinators; 39 Therapists and Supervisors; 11 Project Directors and and Supervisors; 11 Project Directors and Protocol Principal Investigators; 27 Quality Protocol Principal Investigators; 27 Quality Assurance Monitors and Data ManagersAssurance Monitors and Data Managers

My wonderful colleagues: Nathilee Caldeira, Ph.D., My wonderful colleagues: Nathilee Caldeira, Ph.D., Aimee Campbell, Ph.D., Lisa Cohen, Ph.D., Mei-Chen Aimee Campbell, Ph.D., Lisa Cohen, Ph.D., Mei-Chen Hu, Ph.D., Huiping Jiang, Ph.D., Lisa Litt, Ph.D., Hu, Ph.D., Huiping Jiang, Ph.D., Lisa Litt, Ph.D., Antonio Morgan-Lopez, Ph.D., Gloria Miele, Ph.D., Antonio Morgan-Lopez, Ph.D., Gloria Miele, Ph.D., Edward V. Nunes, MD, Lesia Ruglass Ph.D, and Edward V. Nunes, MD, Lesia Ruglass Ph.D, and Lissette Saavedra, Ph.D.Lissette Saavedra, Ph.D.

ADD CTN GRANT NUMBERADD CTN GRANT NUMBER