Intervention for Veterans With Depression, Substance Disorder, and Trauma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00958217
First received: August 11, 2009
Last updated: February 6, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Depression symptoms [ Time Frame: once every 3 months for total of 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: March 2015
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958217

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
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: February 6, 2014
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 April 15, 2014