Intervention for Veterans With Depression, Substance Disorder, and Trauma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00958217
First received: August 11, 2009
Last updated: February 22, 2016
Last verified: February 2016
  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
Depressive Symptoms
Substance-related Disorders
Posttraumatic Stress Disorders
Behavioral: Cognitive Processing Therapy-Modified (CPT-M)
Behavioral: Integrated Cognitive Behavioral Therapy (ICBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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 VA Office of Research and Development:

Primary Outcome Measures:
  • Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale. [ Time Frame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) ] [ Designated as safety issue: No ]
    Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.

  • Posttraumatic Stress Disorder (PTSD) Symptoms [ Time Frame: Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months) ] [ Designated as safety issue: No ]
    The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.

  • Timeline Followback [ Time Frame: Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months) ] [ Designated as safety issue: No ]
    The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization.


Enrollment: 154
Study Start Date: December 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Processing Therapy-Modified
12 individually delivered sessions of Cognitive Processing Therapy-Modified (CPT-M) provided once weekly following initial group delivery of 12 sessions of Integrated Cognitive Behavioral Therapy
Behavioral: Cognitive Processing Therapy-Modified (CPT-M)
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, reduce depression and substance relapse. CPT-M was delivered in individual 1-hour sessions once weekly.
Active Comparator: Integrated Cognitive Behavioral Therapy
12 individually delivered sessions of Integrated Cognitive Behavioral Therapy (ICBT) once weekly following initial group delivery of 12 sessions of ICBT
Behavioral: Integrated Cognitive Behavioral Therapy (ICBT)
Psychotherapy that focuses on thoughts and behaviors associated with depression with the goal of developing skills to reduce depression symptoms. We have integrated substance relapse prevention skills. ICBT was delivered in individual 1-hour sessions once weekly.
No Intervention: Integrated Cognitive Behavioral Group Therapy
All participants were enrolled in an initial group-delivered Integrated Cognitive Therapy Group, consisting of 12 sessions over approximately 12 weeks prior to randomization to one of the study individually delivered interventions (CPT-M or ICBT). Individuals who were no longer participating in the study at the end of group sessions were not randomized.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
VA Office of Research and Development
Investigators
Principal Investigator: Susan Tate, PhD VA San Diego Healthcare System, San Diego/University of California, San Diego
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00958217     History of Changes
Other Study ID Numbers: MHBA-016-09S 
Study First Received: August 11, 2009
Results First Received: June 26, 2015
Last Updated: February 22, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Depressive symptoms
Substance-related disorders
Posttraumatic stress disorders
Psychotherapy

Additional relevant MeSH terms:
Depression
Stress Disorders, Traumatic
Disease
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders
Pathologic Processes
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 22, 2016