Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Condition: Posttraumatic Stress Disorder; Substance Dependence
MeSH terms: Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether a novel integrated cognitive-behavioral
      treatment for posttraumatic stress disorder (PTSD) and substance dependence (i.e., Treatment
      for Integrated Posttraumatic Stress and Substance use; TIPSS) is more effective than
      cognitive-behavioral treatment for substance dependence alone with regard to PTSD symptoms
      and substance use quantity and frequency.
    

Detailed description: 
      The proposed study is a randomized controlled clinical trial, comparing the efficacy of two
      cognitive-behavioral therapy (CBT) interventions: standard CBT for substance dependence and a
      novel integrated CBT program for PTSD and substance dependence. The study will run for
      approximately 3 years. A total of 100 participants will be enrolled at a rate of 4
      participants per month over 25 months to ensure that 80 participants complete the protocol
      (presuming 20% attrition). Each participant will attend 12 treatment sessions, meeting twice
      per week for 6 weeks. Treatment sessions will last 1-hour each.

      Primary study outcomes will include frequency and quantity of substance use and PTSD symptom
      severity. Substance use-related outcomes will include: rates of substance abstinence, as
      measured by (1) urine toxicology testing, (2) alcohol breath level analyses, and (3)
      participants' self-report of substance use. PTSD symptom outcomes will include symptom
      severity ratings as measured by clinical interview (i.e., Clinician-Administered PTSD
      Scale-5; CAPS-5) and self-report (Posttraumatic Checklist; PCL-5).

      Secondary study outcomes will include examination of mediational effects. Specifically,
      changes in distress tolerance, as indexed via self-report (Distress Tolerance Scale) and
      computer/behavioral tasks (i.e., Mirror-Tracing Task, Paced Auditory Serial Addition
      Task-Computerized Version, Breath-Holding Task), are expected during the course of the
      treatment. Changes in cue reactivity are also expected over the course of treatment, as
      indexed by decreased psychophysiological reactivity (heart rate, respiration rate) during
      script-driven imagery tasks (listening to trauma/drug related scripts vs. netural). A total
      of four sessions (baseline/screening and sessions 4, 8, 12) will be preceded by the
      laboratory sessions.
    

Intervention name(s): Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS); Cognitive-Behavioral Therapy for Substance Dependence
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Topics covered include:
drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities; education on PTSD and trauma/PTSD/substance use associations; discussion and written statement of impact of trauma on beliefs about self, others, world; written account of trauma memory and in-session review and discussion; cognitive exercises and cognitive restructuring regarding trauma-related thoughts; review of any between-session trauma-relevant substance use and cravings; Topics covered include:
drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: posttraumatic stress disorder; PTSD; substance dependence; substance use