Telehealth treatment for alcohol use disorder involving family support
Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder Among Veterans
This study is testing a new telehealth program that includes family support to see if it helps Veterans with alcohol use disorder do better in treatment compared to standard care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05674409 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new telehealth intervention called Brief Family-Involved Treatment (B-FIT) designed to improve treatment outcomes for Veterans with alcohol use disorder (AUD). The intervention is delivered alongside standard Cognitive Behavioral Therapy (CBT) and aims to enhance family involvement in the treatment process. The study is a 12-week, open randomized controlled trial comparing the effectiveness of B-FIT combined with treatment as usual against treatment as usual alone. By focusing on family dynamics, the study seeks to optimize engagement and reduce relapse rates among Veterans struggling with AUD.
Who should consider this trial
Good fit: Ideal candidates include Veterans aged 21 or older who meet the criteria for moderate to severe alcohol use disorder and have a willing family member or treatment companion.
Not a fit: Patients who do not have a family member or treatment companion willing to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment engagement and outcomes for Veterans with alcohol use disorder.
How similar studies have performed: Other studies have shown success with family-involved approaches in addiction treatment, suggesting potential for this novel telehealth intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Inclusion criteria for Veterans require that they: 1. 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 2. Have an adult family member/treatment companion who is willing to participate 3. Demonstrate cognitive functioning sufficient to provide informed consent and participate accurately (≥ 26 on the Mini-Mental Status Exam \[MMSE\]) 4. 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. Inclusion criteria for the family member/treatment companion require that they: 1. Are not receiving or seeking treatment for their own alcohol or drug problem 2. Report total Alcohol Use Disorders Identification Test (AUDIT) scores \<8 3. Report total Drug Abuse Screening Test (DAST-10) scores \<3. Exclusion Criteria: Exclusion criteria for all participants include: 1. History of or current psychotic or bipolar disorder 2. Alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) score \>8) 3. Current suicidal or homicidal ideation and intent 4. Severe or unilateral violence in the past 6 months as measured by the Revised Conflict Tactics Scale (CTS2) (consistent with extant dyadic treatment literature).
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Stacey Sellers, MS
- Email: sellersst@musc.edu
- Phone: 843-792-5807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.