Cognitive Behavioral Therapy (CBT) for Posttraumatic Stress Disorder (PTSD) in Community Addiction Treatment
A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment
1 other identifier
interventional
443
1 country
4
Brief Summary
The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as delivered by routine addiction counselors in community treatment programs, and to compare CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the primary outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2010
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFebruary 16, 2015
February 1, 2015
3.3 years
October 4, 2011
February 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Decrease from baseline in PTSD symptom severity (Clinician Administered PTSD Scale (CAPS) score (30 day)) at 3-months and at 6-months
Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in positive toxicology screens (urine drug screen and breathalyzer) at 3-months and at 6-months
Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in drug and alcohol symptom severity (Addiction Severity Index (ASI)-Self Administered (30 day)) at 3-months and at 6-months
Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in frequency of substance use (Timeline Follow-Back (TLFB) Interview (90 day)) at 3-months and at 6-months
Baseline, 3-month, & 6-month follow-ups
Secondary Outcomes (2)
Difference in treatment retention (continuation and completion of ICBT or IAC)
From date of treatment commencement until treatment completion, assessed up to approx. 12 weeks
Therapist adherence and competence (ICBT or IAC)
Duration of study intervention
Study Arms (3)
Cognitive Behavioral Therapy
EXPERIMENTALCognitive Behavioral Therapy (CBT) is a non-exposure based manual-guided individual therapy. CBT for PTSD consists of 3 learning and skill components designed to improve PTSD symptoms and substance use: 1) Patient education about PTSD and its relation to substance use and treatment; 2) Breathing retraining: A behavioral anxiety reduction skill; and 3) Cognitive restructuring: A cognitive approach and functional analysis of the link among emotions, cognitions and situations.
Individual Addiction Counseling
ACTIVE COMPARATORIndividual Addiction Counseling (IAC) was adapted from the Individual Drug Counseling (IDC) manual used in the NIDA Cocaine Collaborative Study. IAC is a manual-guided treatment that focuses on substance use and history of use, consequences of use and denial, developing strategies for relapse prevention, and facilitation of connection with peer recovery support groups, specifically twelve step groups. The current adaptation of IAC modified the IDC manual by broadening the focus to include drugs other than cocaine, as well as alcohol.
Treatment-as-usual
ACTIVE COMPARATORTreatment-as-usual (TAU) is the typical intensive outpatient (IOP) treatment that the patient would receive ordinarily at the identified addiction treatment program. Each TAU service operates using the American Society of Addiction Medicine criteria for Level II Intensive Outpatient services: 9-12 hours per week; group and individual sessions focused on motivation to address substance use, education about the consequences of substance use on major life areas, education about the disease concept and brain changes associated with addiction, exposure to information about social and family relationships and recovery, and relapse prevention skills.
Interventions
Individual CBT, approx. 12 sessions, one session per week
Individual therapy, approx. 12 sessions, one session per week
Individual or group therapy, approx. 9-12 hours per week, multiple times a week for 2 months
Eligibility Criteria
You may qualify if:
- At least 18 years old;
- Actively enrolled in outpatient addiction services and meets criteria for substance use disorder;
- Screened positive for PTSD (results of PCL show a likely Criterion A Traumatic Event and a score equal to or greater than 44);
- Willing and able to provide informed consent to participate in the study;
- Diagnosis of PTSD verified by the CAPS and total symptom score equal to or greater than 44;
You may not qualify if:
- Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if their symptoms are stable and they are well connected with appropriate mental health services);
- Psychiatric hospitalization or suicide attempt in the past month (however, if the hospitalization or attempt was directly related to substance intoxication or detoxification and the person is currently stable, they are eligible);
- Medical and/or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Central Vermont Substance Abuse Services
Berlin Corners, Vermont, 05601, United States
Brattleboro Retreat
Brattleboro, Vermont, 05762, United States
Howard Center
Burlington, Vermont, 05401, United States
Evergreen - Rutland Mental Health
Rutland, Vermont, 05701, United States
Related Publications (2)
Meier A, McGovern MP, Lambert-Harris C, McLeman B, Franklin A, Saunders EC, Xie H. Adherence and competence in two manual-guided therapies for co-occurring substance use and posttraumatic stress disorders: clinician factors and patient outcomes. Am J Drug Alcohol Abuse. 2015;41(6):527-34. doi: 10.3109/00952990.2015.1062894. Epub 2015 Aug 18.
PMID: 26286351DERIVEDMcGovern MP, Lambert-Harris C, Xie H, Meier A, McLeman B, Saunders E. A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. Addiction. 2015 Jul;110(7):1194-204. doi: 10.1111/add.12943.
PMID: 25846251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark P. McGovern, Ph.D.
Geisel School of Medicine at Dartmouth College
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry and of Community and Family Medicine
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 24, 2011
Study Start
December 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
February 16, 2015
Record last verified: 2015-02