Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This treatment intervention trial is designed for men and women with substance dependence and
      comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one
      of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and Substance
      Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy] and an active
      monitoring control group) and will be evaluated at baseline and four follow-up points
      (post-treatment, 1-month, 2- month and 3-month post-treatment).
    

Detailed description: 
      This study will enhance the knowledge and understanding of concurrently treating individuals
      with substance use disorders and PTSD in hopes of facilitating treatment retention and
      increasing the likelihood for more positive treatment outcomes. Following NIDA's stage model
      for behavior therapies development, this study will take the next step building upon
      promising findings from Stage IA work with an exposure-based therapy modified to use safely
      with substance dependent individuals.

      This study is a randomized clinical trial to assess the relative efficacy of two active
      treatment conditions versus an active monitoring control group for substance dependent
      individuals who also meet criteria for current PTSD according to the diagnostic standards set
      by the DSM-IV. Eligible participants will be randomly assigned to either: (1) Concurrent
      Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE); (2) Relapse
      Prevention Treatment (RPT) or an (3) Active Monitoring Control Group (AMCG). The study is a
      three armed randomized controlled trial with repeated outcome measures at post treatment and
      1-,2-, and 3-months post-treatment follow-up points for participants in COPE and RPT.
    

Intervention name(s): Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure; Relapse Prevention Treatment; Active Monitoring Control Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues.; Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.; Participants meet with study staff on a weekly basis for the self-monitoring of PTSD and SUD symptoms. Visits consists of self-report assessments, urine toxicology, and a brief check-in with staff to confirm general health and safety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Co-morbid substance disorders and PTSD; Trauma; Alcohol and other drug use disorders; Treatment outcome; Post-Traumatic Stress Disorder (PTSD); Co-morbid Alcohol and other drug use disorders (AOD); Behavioral Treatment