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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: July 15, 2014
Last verified: July 2014

August 11, 2009
July 15, 2014
December 2009
April 2014   (final data collection date for primary outcome measure)
Depression symptoms [ Time Frame: once every 3 months for total of 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958217 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intervention for Veterans With Depression, Substance Disorder, and Trauma
Intervention for Veterans With Depression, Substance Disorder, and Trauma

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depressive Symptoms
  • Substance-related Disorders
  • Posttraumatic Stress Disorders
  • 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 1
    Individuals with depression and substance disorders and trauma history without PTSD diagnosis
    Interventions:
    • Behavioral: ICBT: Integrated Cognitive Behavioral Therapy
    • Behavioral: CPT-M: Cognitive Processing Therapy-Modified
  • Arm 2
    Individuals with depression and substance disorders with a PTSD diagnosis
    Interventions:
    • Behavioral: ICBT: Integrated Cognitive Behavioral Therapy
    • Behavioral: CPT-M: Cognitive Processing Therapy-Modified
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
March 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958217
MHBA-016-09S
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Susan Tate, PhD VA San Diego Healthcare System, San Diego
Department of Veterans Affairs
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP