Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Texas A&M University
- Study ID
- NCT05959434
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cognitive Processing Therapy + Relapse Prevention — BEHAVIORALCognitive-Behavioral Therapy that integrates Cognitive Processing Therapy for PTSD with Relapse Prevention for alcohol use disorder
- Relapse Prevention — BEHAVIORALCognitive-Behavioral Therapy that targets alcohol use, specifically
Study Details
The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). Specific Aim 1: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing alcohol frequency (percent days drinking) and quantity (drinks per drinking day) as measured by the Timeline Follow-Back (TLFB). Specific Aim 2: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5). Specific Aim 3: Use ecological momentary assessment (EMA) to evaluate intervention effects on daily alcohol-related cognitions and behaviors through real-time associations with PTSD symptomatology and distress tolerance. Researchers will compare integrative CPT+RP with RP-alone to see if CPT+RP is more efficacious in reducing alcohol use and PTSD symptom severity.
Key Dates
- Start date
- Apr 1, 2024
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP)Participants will receive 12, 90-minute individual sessions of CPT+RP delivered twice-weekly. We will offer some flexibility (e.g., due to illness or scheduling conflicts) and allow up to 9 weeks to complete all 12 sessions if needed. During CPT+RP, patients receive psychoeducation pertaining to the interconnectedness of AUD and PTSD and learn techniques to identify and manage triggers for alcohol use, cope with cravings, address problem thoughts about drinking, and enhance social support. These skills address core functional outcomes relevant to addiction, including executive functioning, incentive salience, and negative emotionality. The PTSD treatment component of CPT+RP reduces PTSD symptoms via identifying and targeting maladaptive trauma-related cognitions, beliefs, and Stuck Points via cognitive restructuring exercises, such as Socratic questioning. RP skills are integrated within each session.
- Active Comparator: Relapse Prevention (RP)Participants will receive 12, 90-minute individual sessions of RP delivered twice-weekly as consistent with the experimental condition. The RP manual is adapted from the NIAAA Project MATCH Cognitive-Behavioral Coping Skills Therapy Manual and has been used in prior NIH-funded trials of integrated, trauma-focused treatment. Session topics include, for example, Triggers for Alcohol Use, Coping with Cravings and Urges to Drink (e.g., avoid alcohol cues, distracting activities, talk to friends/family, urge surfing), Managing Thoughts about Alcohol and Drinking by challenging and changing thoughts, Planning for Emergencies and Coping with a Lapse, Drink Refusal Skills, Increasing Pleasant Activities and Enhancing Social Support.
Primary Outcome Measure
Change in Alcohol Use [ Time Frame: through study treatment completion, an average of 12 weeks ]
Central Contacts
- Anka A Vujanovic, Ph.D.979-862-6538
- Sudie E Back, Ph.D.
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Sudie E Back, PHD Stacey Sellers, MS |
| Texas A&M University | College Station | Texas | 77843 |
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