Clinical Trials Directory

Trials / Completed

CompletedNCT00958217

Intervention for Veterans With Depression, Substance Disorder, and Trauma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
154 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will compare two different types of psychotherapy for Veterans with depression, addiction, and a past traumatic experience. Everyone in the study will receive 12 weeks of group cognitive behavioral therapy focused on depression and addiction, followed by 12 weeks of individual psychotherapy sessions. For the second 12 weeks, half of the people will receive a review of the initial therapy, and half will receive a cognitive behavioral therapy focused on trauma. Everyone will complete research interviews every 3 months for a total of 18 months.

Detailed description

The goal of this study is to evaluate whether a second disorder-specific intervention improves longer term (up to 18 months) treatment outcomes for male and female Veterans with co-occurring depression and alcohol/substance disorders and trauma history (with or without PTSD diagnosis). This 4 years randomized two-group design uses repeated assessments at baseline and every 3 months for a total of 12 months. The investigators are providing their recently developed integrated intervention for comorbid depression and substance disorders for the initial 12 weeks in group format (Integrated Cognitive Behavioral Therapy; Phase I). After the 12 week group intervention, participants will be randomized to receive either a review of the initial intervention in individual sessions, or a trauma-specific intervention, Cognitive Processing Therapy, with integrated addiction treatment components. Length, duration, and setting of both interventions will be the same, and all participants will meet with the program psychiatrist for medication appointments. No medications are under study and no placebo is used; medications will be prescribed using standard VA protocol. Research assessments will document diagnosis, recent substance use, depression and PTSD symptoms, medication adherence, and life stress.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Processing Therapy-Modified (CPT-M)Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills, reduce depression and substance relapse. CPT-M was delivered in individual 1-hour sessions once weekly.
BEHAVIORALIntegrated Cognitive Behavioral Therapy (ICBT)Psychotherapy that focuses on thoughts and behaviors associated with depression with the goal of developing skills to reduce depression symptoms. We have integrated substance relapse prevention skills. ICBT was delivered in individual 1-hour sessions once weekly.

Timeline

Start date
2009-12-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2009-08-13
Last updated
2016-03-24
Results posted
2016-03-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00958217. Inclusion in this directory is not an endorsement.