Brief Family Involved Treatment Telehealth
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Medical University of South Carolina
- Study ID
- NCT05674409
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Brief Family-Involved Treatment (B-FIT) — BEHAVIORALBrief Family-Involved Treatment (B-FIT) is a manualized, 3-session intervention for Alcohol Use Disorder (AUD). Designed to be implemented in combination with any existing alcohol treatment program, the goals of B-FIT are to (1) increase reinforcement for AUD treatment engagement, (2) increase positive rewards from drinking reductions, and (3) decrease drinking cues by decreasing negative communication and increasing positive communication.
- Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD) — BEHAVIORALParticipants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).
Study Details
Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans. The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy. This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual (TAU), (in this case B-FIT+ Cognitive Behavioral Therapy treatment) as compared to TAU alone (CBT treatment).Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 \& 6 month follow-up assessments, all via telehealth.
Key Dates
- Start date
- Mar 13, 2023
- Status verified
- Feb 2026
- Primary completion
- Mar 1, 2028
- Completion
- Mar 1, 2029
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cognitive Behavioral Therapy + Brief Family-Involved TreatmentApproximately half of enrolled veterans and their treatment companion will be randomly assigned to the experimental group. The identified veteran participant wil receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD). In addition, both the identified veteran and their treatment companion will receive an additional 3 sessions of Brief Family-Involved Treatment (B-FIT). B-FIT is a manualized, 3-session AUD intervention, designed to be implemented in combination with any existing alcohol treatment program.
- Active Comparator: Cognitive Behavioral TherapyApproximately half of enrolled veterans and their treatment companion will be randomly assigned to the active comparator group. The identified veteran participant wil receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).
Primary Outcome Measure
Family functioning [ Time Frame: From baseline to week 12 ]
Central Contacts
- Stacey Sellers, MS843-792-5807
- Julianne Flanagan, PhD843-792-5569
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29401 | Julianne Flanagan, Ph.D (PRINCIPAL_INVESTIGATOR) |
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