Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD (NCT05959434) | Clinical Trial Compass
RecruitingPhase 2
Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
United States200 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Alcohol Use
Timeframe: through study treatment completion, an average of 12 weeks
2
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
Timeframe: through study treatment completion, an average of 12 weeks
✕. 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.