Cognitive Behavioral Therapy for Post Traumatic Stress Disorder in Addiction Treatment
2 other identifiers
interventional
78
1 country
6
Brief Summary
The purpose of this phase of the study is to further assess the efficacy of cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD), as delivered by routine addiction counselors, and to compare CBT for PTSD with individual addiction counseling (IAC) on our 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_2
Started Jun 2007
6 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
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedOctober 20, 2011
October 1, 2011
1.8 years
October 3, 2011
October 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months
Baseline, 3-month, & 6-month follow-up
Secondary Outcomes (2)
Difference in treatment retention between ICBT and IAC at treatment completion, approx. 12 weeks
From date of treatment commensement until treatment completion, assessed up to 12 weeks
Reduction from baseline in substance use severity (Addiction Severity Index [ASI]) at 3-months and at 6-months
Baseline, 3-month & 6-month follow-up
Study Arms (2)
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.
Interventions
Individual CBT, approx. 12 sessions, one session per week
Individual therapy, approx. 12 sessions, one session per week
Eligibility Criteria
You may qualify if:
- At least 18 years old;
- Actively enrolled in outpatient addiction services and meets criteria for any 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 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 (6)
Hartford Dispensary
Hartford, Connecticut, 06120, United States
Addiction Treatment Program at DHMC
Lebanon, New Hampshire, 03756, United States
Farnum Center
Manchester, New Hampshire, 03101, United States
WestBridge
Manchester, New Hampshire, 03101, United States
Starting Now - Brattleboro Retreat
Brattleboro, Vermont, 05301, United States
Quitting Time - Clara Martin Center
Wilder, Vermont, 05088, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark P. McGovern, Ph.D.
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry and of Community and Family Medicine
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 20, 2011
Study Start
June 1, 2007
Primary Completion
April 1, 2009
Study Completion
August 1, 2009
Last Updated
October 20, 2011
Record last verified: 2011-10