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NCT07903974
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Conditions: Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
Summary
This project will test the effectiveness of a stepped-care talk therapy model for patients with PTSD and Hazardous Alcohol use (HAU). Specifically, the researchers are testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after five sessions is more helpful than staying with the same therapy, depending on how well it is working.
Eligibility Criteria
Patients will be eligible for the study if they:
1. are age 18 years or older
2. receive care at a participating Federally Qualified Health Center (FQHC)
3. have a PTSD checklist (PCL)-5 score ≥28
4. show probable HAU as measured by the Alcohol Use Disorders Identification Test (AUDIT) (score of 8-25 for men, 6-25 for women with past-month alcohol use)
5. have had psychotropic medication stability for at least 4 weeks
6. speak English
Patients will be eligible for the qualitative portion of the study if they:
1. Enrolled into the randomized controlled trial (RCT) AND
2. Were a treatment responder OR
3. Were a treatment non-responder
Patients will be excluded if they have:
1. severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
2. high risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: see section 7.8. Suicide Risk Protocol)
3. active psychosis or unmanaged bipolar disorder
6\) current engagement in a trauma- or alcohol-focused treatment 7) Patients who do not speak English will be excluded for logistical reasons
Source: ClinicalTrials.gov (NCT07903974). StuddyBuddy aggregates publicly available trial information.