An interventional study of Brief Family-Involved Treatment (B-FIT) and Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD) in Alcohol Use Disorder, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
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).
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 400 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
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Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Inclusion Criteria:
Inclusion criteria for Veterans require that they:
Inclusion criteria for the family member/treatment companion require that they:
Exclusion Criteria:
Exclusion criteria for all participants include:
Approximately 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.
Behavioral: Brief Family-Involved Treatment (B-FIT) · Behavioral: Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)
Approximately 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).
Behavioral: Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)
Brief 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.
Participants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).
Family functioning
Change in family functioning as measured by the Brief Family Assessment Measure-III (Brief FAM-III)
Time frame: From baseline to week 12
Change in Alcohol Consumption
Change in percent days abstinent, as measured by the Alcohol Timeline Followback (TLFB)
Time frame: From baseline to week 12
Change in percent days drinking
Change in percent days drinking, as measured by the Alcohol Timeline Followback (TLFB)
Time frame: From baseline to week 12
Change in drinks per drinking day
Change in drinks per drinking day , as measured by the Alcohol Timeline Followback (TLFB)
Time frame: From baseline to week 12
Alcohol problem severity
Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Time frame: From baseline to week 12
Change in alcohol craving
Change in alcohol craving as measured by the Penn Alcohol Craving Scale (PACS)
Time frame: From baseline to week 12
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Medical University of South Carolina