Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas A&M University
About this 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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cognitive Processing Therapy + Relapse Prevention
- Relapse Prevention
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Texas A&M University
Lead sponsor
Medical University of South Carolina
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov