Overview

This trial is active, not recruiting.

Conditions depressive symptoms, substance-related disorders, posttraumatic stress disorders
Treatments icbt: integrated cognitive behavioral therapy, cpt-m: cognitive processing therapy-modified
Phase phase 0
Sponsor Department of Veterans Affairs
Start date December 2009
End date April 2014
Trial size 130 participants
Trial identifier NCT00958217, MHBA-016-09S

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Individuals with depression and substance disorders and trauma history without PTSD diagnosis
icbt: integrated cognitive behavioral therapy
Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse
cpt-m: cognitive processing therapy-modified
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.
(Other)
Individuals with depression and substance disorders with a PTSD diagnosis
icbt: integrated cognitive behavioral therapy
Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse
cpt-m: cognitive processing therapy-modified
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.

Primary Outcomes

Measure
Depression symptoms
time frame: once every 3 months for total of 18 months

Secondary Outcomes

Measure
Posttraumatic Stress Disorder (PTSD) symptoms
time frame: once every 3 months for total of 18 months
Alcohol and drug use
time frame: once every 3 months for total of 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Veterans 18 years of age and older living in the San Diego, CA area - Who are able to attend in-person therapy sessions - Have depression, alcohol or substance addiction, and a past traumatic experience Exclusion Criteria: - Non-veterans - Individuals with schizophrenia or severe memory impairment

Additional Information

Official title Intervention for Veterans With Depression, Substance Disorder, and Trauma
Principal investigator Susan Tate, PhD
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. We are providing our 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.