RECRUITING

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

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Conditions

Posttraumatic Stress DisorderAlcohol Use Disordertrauma or PTSDalcohol useCognitive Processing TherapyRelapse Prevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-04-01
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05959434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Any gender identity, any race or ethnicity, aged 18-70 years.
  2. 2. Able to provide written informed consent.
  3. 3. Ability to understand English.
  4. 4. Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder (\> 4 criteria).
  5. 5. 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.
  6. 6. Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5 (score of \> 25).
  7. 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. 8. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.
  1. 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. 2. Participants on psychotropic medications which have been initiated during the past 4 weeks.
  3. 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. 4. Pregnancy or breastfeeding for women.
  5. 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.

Contacts and Locations

Study Contact

Anka A Vujanovic, Ph.D.
CONTACT
979-862-6538
avujanovic@tamu.edu
Sudie E Back, Ph.D.
CONTACT
backs@musc.edu

Principal Investigator

Anka A Vujanovic, Ph.D.
PRINCIPAL_INVESTIGATOR
Texas A&M University
Sudie E Back, Ph.D.
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Texas A&M University
College Station, Texas, 77843
United States

Collaborators and Investigators

Sponsor: Texas A&M University

  • Anka A Vujanovic, Ph.D., PRINCIPAL_INVESTIGATOR, Texas A&M University
  • Sudie E Back, Ph.D., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Posttraumatic Stress Disorder
  • Alcohol Use Disorder