Intervention for Veterans With Depression, Substance Disorder, and Trauma

Depressive Symptoms Clinical Trial

Official title:

Intervention for Veterans With Depression, Substance Disorder, and Trauma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00958217
• Other study ID #: MHBA-016-09S
• Status: Active, not recruiting
• Phase: Phase 0
• First received: August 11, 2009
• Last updated: January 6, 2015
• Start date: December 2009
• Est. completion date: March 2015

Study information

• Verified date: January 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: March 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Symptoms
• Disease
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance-Related Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms		once every 3 months for total of 18 months	No
Secondary	Posttraumatic Stress Disorder (PTSD) symptoms		once every 3 months for total of 18 months	No
Secondary	Alcohol and drug use		once every 3 months for total of 18 months	No