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

August 11, 2009
February 22, 2016
December 2009
May 2014   (final data collection date for primary outcome measure)
  • 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.
Depression symptoms [ Time Frame: once every 3 months for total of 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00958217 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
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. 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depressive Symptoms
  • Substance-related Disorders
  • Posttraumatic Stress Disorders
  • 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.
  • 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.
  • 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
    Intervention: Behavioral: Cognitive Processing Therapy-Modified (CPT-M)
  • 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
    Intervention: Behavioral: Integrated Cognitive Behavioral Therapy (ICBT)
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958217
MHBA-016-09S
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Susan Tate, PhD VA San Diego Healthcare System, San Diego/University of California, San Diego
VA Office of Research and Development
February 2016

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