NCT05959434 Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
| NCT ID | NCT05959434 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Texas A&M University |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2024-04-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Any gender identity, any race or ethnicity, 18 years of age or older. 2. Able to provide written informed consent. 3. Ability to understand English. 4. Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( \>= 4 criteria). 5. 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. 6. Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5. 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. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation. Exclusion Criteria: 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. Participants on psychotropic medications which have been initiated during the past 4 weeks. 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. Pregnancy or breastfeeding for women. 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.
Contact & Investigator
Anka A Vujanovic, Ph.D.
PRINCIPAL INVESTIGATOR
Texas A&M University
Frequently Asked Questions
Who can join the NCT05959434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05959434 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05959434 currently recruiting?
Yes, NCT05959434 is actively recruiting participants. Contact the research team at avujanovic@tamu.edu for enrollment information.
Where is the NCT05959434 trial being conducted?
This trial is being conducted at Charleston, United States, College Station, United States.
Who is sponsoring the NCT05959434 clinical trial?
NCT05959434 is sponsored by Texas A&M University. The principal investigator is Anka A Vujanovic, Ph.D. at Texas A&M University. The trial plans to enroll 200 participants.