Clinical trial NCT00958217: Intervention for Veterans With Depression, Substance Disorder, and Trauma
Official title: Intervention for Veterans With Depression, Substance Disorder, and Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Substance-related Disorders
Posttraumatic Stress Disorders
Keywords: Depressive symptoms
Substance-related disorders
Posttraumatic stress disorders
Psychotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-08-13
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.
timeFrame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)
measure: Posttraumatic Stress Disorder (PTSD) Symptoms
timeFrame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)
measure: Timeline Followback
timeFrame: Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego/University of California, San Diego
name: Susan Tate, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegel EY, Haller M, Cui R, Trim RS, Tate SR, Norman SB. Examining changes in negative mood regulation expectancies, posttraumatic stress disorder, depression, and substance use following integrated cognitive-behavioral therapy. Subst Abus. 2017 Oct-Dec;38(4):468-472. doi: 10.1080/08897077.2017.1342736. Epub 2017 Jun 20.
citation: Cui R, Haller M, Skidmore JR, Goldsteinholm K, Norman S, Tate SR. Treatment Attendance Among Veterans With Depression, Substance Use Disorder, and Trauma. J Dual Diagn. 2016;12(1):15-26. doi: 10.1080/15504263.2016.1146384.