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

NCT05959434 | Recruiting Phase 2 DMC

• 2 other identifiers: IRB2023-0985 / 162260R01AA030157
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Alcohol Use

  Composite of alcohol use frequency (percent days drinking) and quantity (drinks per drinking day), as measured by the Timeline Follow-Back

  through study treatment completion, an average of 12 weeks

• Change in Posttraumatic Stress Disorder (PTSD) Symptoms

  PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  through study treatment completion, an average of 12 weeks

Secondary Outcomes (2)

• Change in Alcohol Use

  At 3 months, 6 months, and 12 months following study treatment completion

• Change in Posttraumatic Stress Disorder (PTSD) Symptoms

  At 3 months, 6 months, and 12 months following study treatment completion

Study Arms (2)

Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP)

EXPERIMENTAL

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.

Behavioral: Cognitive Processing Therapy + Relapse Prevention

Relapse Prevention (RP)

ACTIVE COMPARATOR

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.

Behavioral: Relapse Prevention

Interventions

Cognitive Processing Therapy + Relapse Prevention BEHAVIORAL

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

Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP)

Relapse Prevention BEHAVIORAL

Cognitive-Behavioral Therapy that targets alcohol use, specifically

Relapse Prevention (RP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender identity, any race or ethnicity, 18 years of age or older.
• Able to provide written informed consent.
• Ability to understand English.
• Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( \>= 4 criteria).
• 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.
• Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5.

You may not qualify if:

• Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.
• 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.
• Participants on psychotropic medications which have been initiated during the past 4 weeks.
• 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.
• Pregnancy or breastfeeding for women.
• 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.

Sponsors & Collaborators

• Texas A&M University: lead
• Medical University of South Carolina: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Texas A&M University

College Station, Texas, 77843, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism; Wounds and Injuries; Alcohol Drinking

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Anka A Vujanovic, Ph.D.

  Texas A&M University

  PRINCIPAL INVESTIGATOR

• Sudie E Back, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anka A Vujanovic, Ph.D.

CONTACT

979-862-6538; avujanovic@tamu.edu

Sudie E Back, Ph.D.

CONTACT

backs@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: July 25, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)