Intervention for Veterans With Depression, Substance Disorder, and Trauma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Symptoms Substance-related Disorders Posttraumatic Stress Disorders |
Behavioral: ICBT: Integrated Cognitive Behavioral Therapy Behavioral: CPT-M: Cognitive Processing Therapy-Modified |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intervention for Veterans With Depression, Substance Disorder, and Trauma |
- Depression symptoms [ Time Frame: once every 3 months for total of 18 months ] [ Designated as safety issue: No ]
- Posttraumatic Stress Disorder (PTSD) symptoms [ Time Frame: once every 3 months for total of 18 months ] [ Designated as safety issue: No ]
- Alcohol and drug use [ Time Frame: once every 3 months for total of 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1
Individuals with depression and substance disorders and trauma history without PTSD diagnosis
|
Behavioral: 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
Behavioral: 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.
|
|
Arm 2
Individuals with depression and substance disorders with a PTSD diagnosis
|
Behavioral: 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
Behavioral: 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.
|
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. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| VA San Diego Healthcare System, San Diego | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Susan Tate, PhD | VA San Diego Healthcare System, San Diego |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00958217 History of Changes |
| Other Study ID Numbers: | MHBA-016-09S |
| Study First Received: | August 11, 2009 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Depressive symptoms Substance-related disorders Posttraumatic stress disorders Psychotherapy |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders |
Behavioral Symptoms Mood Disorders Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on June 18, 2013