Combining Cognitive Processing Therapy and Relapse Prevention for PTSD and Alcohol Use Disorder

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

This study is testing if a new combined treatment of therapy for PTSD and help for alcohol use can work better than just the alcohol help alone for people dealing with both issues.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Texas A&M University (other)
• Locations: 2 sites (Charleston, South Carolina and 1 other locations)
• Trial ID: NCT05959434 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of an integrated cognitive-behavioral intervention that combines Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) for individuals suffering from both posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). The study will compare the outcomes of participants receiving the combined treatment against those receiving RP alone, focusing on reductions in alcohol consumption and PTSD symptoms. Researchers will utilize various assessment tools, including the Timeline Follow-Back (TLFB) and the Clinician Administered PTSD Scale (CAPS-5), to measure the efficacy of the interventions. Additionally, ecological momentary assessment (EMA) will be employed to capture real-time data on alcohol-related thoughts and behaviors in relation to PTSD symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 who meet the diagnostic criteria for moderate to severe alcohol use disorder and PTSD.

Not a fit: Patients who do not meet the criteria for alcohol use disorder or PTSD, or those with bipolar affective disorder, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve treatment outcomes for patients with co-occurring PTSD and alcohol use disorder.

How similar studies have performed: Previous studies have shown promise in integrating cognitive-behavioral therapies for treating co-occurring PTSD and substance use disorders, indicating a strong potential for success with this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Any gender identity, any race or ethnicity, 18 years of age or older.
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.

Where this trial is running

Charleston, South Carolina and 1 other locations

• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
• Texas A&M University — College Station, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Anka A Vujanovic, Ph.D. — Texas A&M University
• Study coordinator: Anka A Vujanovic, Ph.D.

Conditions: Posttraumatic Stress Disorder, Alcohol Use Disorder, trauma or PTSD, alcohol use, Cognitive Processing Therapy, Relapse Prevention