Recruiting
Phase 2

CPT & Relapse Prevention

Sponsor:

Texas A&M University

Code:

NCT05959434

Conditions

Posttraumatic Stress Disorder

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Processing Therapy + Relapse Prevention

Relapse Prevention

Study Details

Brief 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.

Conditions

Posttraumatic Stress Disorder

Alcohol Use Disorder

Study ID

NCT05959434

Start date

Apr 1, 2024

Status verified date

Apr, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cognitive Processing Therapy + Relapse Prevention

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

Relapse Prevention

Cognitive-Behavioral Therapy that targets alcohol use, specifically

Primary outcome measure

  • Change in Alcohol Use [ Time Frame: through study treatment completion, an average of 12 weeks ]
  • Change in Posttraumatic Stress Disorder (PTSD) Symptoms [ Time Frame: through study treatment completion, an average of 12 weeks ]

Central Contacts and Locations

Central contacts

Anka A Vujanovic, Ph.D.

979-862-6538avujanovic@tamu.edu

Sudie E Back, Ph.D.

backs@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Sudie E Back, PHD

backs@musc.edu

Stacey Sellers, MS

sellersst@musc.edu

Texas A&M University

Recruiting

College Station, Texas, United States, 77843

Contacts

More Information

Sponsor

Texas A&M University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • trauma or PTSD
  • alcohol use
  • Cognitive Processing Therapy
  • Relapse Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas A&M University on 2026-04-24.