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RECRUITING

NCT05959434

PHASE2

Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD

Sponsor: Texas A&M University

View on ClinicalTrials.gov

Summary

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.

Official title: Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-04-01

Completion Date

2028-07-31

Last Updated

2025-10-29

Healthy Volunteers

Conditions

Posttraumatic Stress Disorder Alcohol Use Disorder

Interventions

BEHAVIORAL

Cognitive Processing Therapy + Relapse Prevention

Cognitive-Behavioral Therapy that integrates Cognitive Processing Therapy for PTSD with Relapse Prevention for alcohol use disorder

BEHAVIORAL

Relapse Prevention

Cognitive-Behavioral Therapy that targets alcohol use, specifically

Inclusion Criteria: 1. Any gender identity, any race or ethnicity, aged 18-70 years. 2. Able to provide written informed consent. 3. Ability to understand English. 4. Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( \>= 4 criteria). 5. At least 3 to 4 heavy drinking days per week (4 or more drinks for a woman, 5 or more drinks for a man) in the last 30 days, or \>14 drinks per week for females or \> 21 drinks per week for males for at least 2 weeks in the last 30 days. 6. Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5. 7. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders. The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and anxiety disorders among patients with AUD and PTSD. Concurrent substance use disorders are acceptable provided alcohol is the participant's primary substance of choice. 8. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation. Exclusion Criteria: 1. Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior. The intervention may be insufficient, and those participants will be referred clinically for a higher level of care. 2. Participants on psychotropic medications which have been initiated during the past 4 weeks. 3. Acute alcohol withdrawal as indicated by CIWA-Ar scores \>8. Those participants will be referred clinically for medically supervised detoxification. They may be re-evaluated for eligibility after detoxification. 4. Pregnancy or breastfeeding for women. 5. Currently enrolled in evidence-based behavioral treatment for AUD or PTSD. Attendance at therapeutic activities (e.g., Alcoholics Anonymous) other than study sessions will be closely monitored using the Treatment Services Review.

Locations (2)

Medical University of South Carolina

Charleston, South Carolina, United States

Texas A&M University

College Station, Texas, United States