Brief Family Involved Treatment Telehealth — B-FIT  

Alcohol Use Disorder Clinical Trial

Official title: Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder Among Veterans

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Improving alcohol use disorder (AUD) treatment among Veterans is a national public health priority. The prevalence of AUD among Veterans is twice that of civilians, with up to 50% of Veterans meeting diagnostic criteria for lifetime AUD. Although one in 6 Veterans has an AUD diagnosis in their medical record, substantial barriers to accessing evidence-based AUD treatment persists in this population. While adaptive family support is a critical ingredient to effective AUD treatment and drinking reductions, maladaptive family functioning interferes with AUD recovery and is a precipitant of relapse. Family participation in AUD treatment has the ability to optimize engagement and outcomes.

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. There is an urgent need to develop efficacious family AUD treatments that are both brief and highly accessible to Veterans. Brief Family-Involved Treatment (B-FIT) delivered via telehealth is an intervention distilled from the robustly evidence-based Alcohol Behavioral Couple Therapy (ABCT) model. 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.

The objective of the proposed Stage II study is to evaluate the efficacy of B-FIT delivered via telehealth among Veterans enrolled manualized treatment for AUD (Cognitive Behavioral Therapy, CBT). We will also examine putative individual and family characteristics that mediate treatment outcomes. To accomplish this, we will employ an open randomized controlled design and examine standardized, repeated, dependent measures of change. Veterans and a family member (or concerned partner/friend) will be randomly assigned (matched on age, sex and baseline alcohol consumption) to receive B-FIT in combination with TAU (CBT) or TAU alone. A total of 200 veterans and their treatment companions will be enrolled in this study (N=400). ;

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

• NCT number: NCT05674409
• Study type: Interventional
• Source: Medical University of South Carolina
• Contact: Stacey Sellers, MS
• Phone: 843-792-5807
• Email: sellersst@musc.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Completion date: March 1, 2029