Brief Family Involved Treatment Telehealth
B-FIT
Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder Among Veterans
2 other identifiers
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2023
CompletedStudy Start
First participant enrolled
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
February 5, 2026
February 1, 2026
5 years
December 21, 2022
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Family functioning
Change in family functioning as measured by the Brief Family Assessment Measure-III (Brief FAM-III)
From baseline to week 12
Change in Alcohol Consumption
Change in percent days abstinent, as measured by the Alcohol Timeline Followback (TLFB)
From baseline to week 12
Change in percent days drinking
Change in percent days drinking, as measured by the Alcohol Timeline Followback (TLFB)
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)
From baseline to week 12
Alcohol problem severity
Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT)
From baseline to week 12
Change in alcohol craving
Change in alcohol craving as measured by the Penn Alcohol Craving Scale (PACS)
From baseline to week 12
Study Arms (2)
Cognitive Behavioral Therapy + Brief Family-Involved Treatment
EXPERIMENTALApproximately 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.
Cognitive Behavioral Therapy
ACTIVE COMPARATORApproximately 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- Participants will be 200 Veterans and a family member, plus their treatment companion, a concerned partner or friend (total N=400; 50% women veterans) aged 21 or older.
- Meet diagnostic criteria for current moderate to severe alcohol use disorder (AUD) with 2 or more heavy drinking days (\>5 for men, \>4 for women) in the 60 days prior to enrollment
- Have an adult family member/treatment companion who is willing to participate
- Demonstrate cognitive functioning sufficient to provide informed consent and participate accurately (≥ 26 on the Mini-Mental Status Exam \[MMSE\])
- Maintain a stable dose of psychotropic medications for at least 4 weeks before enrollment. Concurrent drug use disorders are acceptable provided alcohol is the Veteran's primary substance of choice. Drug use will be measured weekly and controlled for in statistical analyses if needed.
- Are not receiving or seeking treatment for their own alcohol or drug problem
- Report total Alcohol Use Disorders Identification Test (AUDIT) scores \<8
- Report total Drug Abuse Screening Test (DAST-10) scores \<3.
You may not qualify if:
- History of or current psychotic or bipolar disorder
- Alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) score \>8)
- Current suicidal or homicidal ideation and intent
- Severe or unilateral violence in the past 6 months as measured by the Revised Conflict Tactics Scale (CTS2) (consistent with extant dyadic treatment literature).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Licensed Clinical Psychologist
Study Record Dates
First Submitted
December 21, 2022
First Posted
January 6, 2023
Study Start
March 13, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
February 5, 2026
Record last verified: 2026-02