Intervention for Veterans With Depression, Substance Disorder, and Trauma

VA Office of Research and Development

Status: Completed

Conditions: Depressive Symptoms; Substance-related Disorders; Posttraumatic Stress Disorders

Treatments: Behavioral: Integrated Cognitive Behavioral Therapy (ICBT); Behavioral: Cognitive Processing Therapy-Modified (CPT-M)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00958217

MHBA-016-09S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veterans 18 years of age and older living in the San Diego, California 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 3 patient groups

Cognitive Processing Therapy-Modified

Experimental group

Description:

12 individually delivered sessions of Cognitive Processing Therapy-Modified (CPT-M) provided once weekly following initial group delivery of 12 sessions of Integrated Cognitive Behavioral Therapy

Treatment:

Behavioral: Cognitive Processing Therapy-Modified (CPT-M)

Integrated Cognitive Behavioral Therapy

Active Comparator group

Description:

12 individually delivered sessions of Integrated Cognitive Behavioral Therapy (ICBT) once weekly following initial group delivery of 12 sessions of ICBT

Treatment:

Behavioral: Integrated Cognitive Behavioral Therapy (ICBT)

Integrated Cognitive Behavioral Group Therapy

No Intervention group

Description:

All participants were enrolled in an initial group-delivered Integrated Cognitive Therapy Group, consisting of 12 sessions over approximately 12 weeks prior to randomization to one of the study individually delivered interventions (CPT-M or ICBT). Individuals who were no longer participating in the study at the end of group sessions were not randomized.