- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05959434
Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD (CPT+RP)
Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sudie E Back, Ph.D.
- Email: backs@musc.edu
Study Contact Backup
- Name: Anka A Vujanovic, Ph.D.
- Phone Number: 979-862-6538
- Email: avujanovic@tamu.edu
Study Locations
-
-
South Carolina
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Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Sudie E Back, PHD
- Email: backs@musc.edu
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Contact:
- Stacey Sellers, MS
- Email: sellersst@musc.edu
-
-
Texas
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College Station, Texas, United States, 77843
- Recruiting
- Texas A&M University
-
Contact:
- Anka A Vujanovic, PHD
- Phone Number: 979-862-6538
- Email: avujanovic@tamu.edu
-
Contact:
- Kayla Hall, MS
- Email: kaylahall@tamu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any gender identity, any race or ethnicity, aged 18-70 years.
- 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 2 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 (score of > 25).
- 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.
- Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Cognitive-Behavioral Therapy that integrates Cognitive Processing Therapy for PTSD with Relapse Prevention for alcohol use disorder
|
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.
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Cognitive-Behavioral Therapy that targets alcohol use, specifically
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Alcohol Use
Time Frame: through study treatment completion, an average of 12 weeks
|
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
Time Frame: through study treatment completion, an average of 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Alcohol Use
Time Frame: At 3 months, 6 months, and 12 months following study treatment completion
|
Composite of alcohol use frequency (percent days drinking) and quantity (drinks per drinking day), as measured by the Timeline Follow-Back
|
At 3 months, 6 months, and 12 months following study treatment completion
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
Time Frame: At 3 months, 6 months, and 12 months following study treatment completion
|
PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
|
At 3 months, 6 months, and 12 months following study treatment completion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sudie E Back, Ph.D., Medical University of South Carolina
- Principal Investigator: Anka A Vujanovic, Ph.D., Texas A&M University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2023-0985 / 162260
- R01AA030157 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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