Your session is about to expire
← Back to Search
Family Therapy for Alcoholism via Telehealth (B-FIT Trial)
N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veterans must demonstrate cognitive functioning sufficient to provide informed consent and participate accurately (≥ 26 on the Mini-Mental Status Exam [MMSE])
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12
Awards & highlights
B-FIT Trial Summary
This trial will evaluate a new, family-based treatment for Veterans with AUD, delivered through telehealth. It will compare this treatment to usual care and measure outcomes at 3 & 6 months.
Who is the study for?
This trial is for Veterans aged 21+ with moderate to severe alcohol use disorder and at least two heavy drinking days recently. They need a family member or friend willing to join the treatment, good mental function (MMSE ≥ 26), and stable psychotropic meds for 4 weeks. Exclusions include those seeking their own substance abuse treatment.Check my eligibility
What is being tested?
The study tests Brief Family-Involved Treatment (B-FIT) via telehealth combined with usual Cognitive Behavioral Therapy (CBT) against CBT alone in Veterans with AUD. It's a randomized trial where participants also do weekly assessments plus follow-ups at months three and six.See study design
What are the potential side effects?
Since this trial involves therapy sessions rather than medication, typical side effects associated with drugs are not expected. However, participants may experience emotional discomfort discussing personal issues during therapy.
B-FIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran with a MMSE score of 26 or higher, able to give informed consent.
B-FIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol problem severity
Change in Alcohol Consumption
Change in alcohol craving
+3 moreB-FIT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy + Brief Family-Involved TreatmentExperimental Treatment2 Interventions
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.
Group II: Cognitive Behavioral TherapyActive Control1 Intervention
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).
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
931 Previous Clinical Trials
7,393,611 Total Patients Enrolled
46 Trials studying Alcoholism
4,705 Patients Enrolled for Alcoholism
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,396 Total Patients Enrolled
29 Trials studying Alcoholism
6,601 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran aged 21 or older, and I have a family member or friend who will join me.I am a veteran with a MMSE score of 26 or higher, able to give informed consent.I am a veteran who has kept my mental health medication dose stable for 4 weeks and primarily use alcohol if I have a substance use issue.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy + Brief Family-Involved Treatment
- Group 2: Cognitive Behavioral Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being examined in this research endeavor?
"Affirmative. Records retrieved from clinicaltrials.gov verify that this research project, initiated on March 13th 2023 and updated most recently on the 16th of the same month, is in pursuit of 400 participants at a single site."
Answered by AI
Is this research project currently enlisting participants?
"Based on the records available at clinicaltrials.gov, this research project is actively searching for participants. The trial was originally listed on March 13th 2023 and most recently updated half a week later."
Answered by AI
Share this study with friends
Copy Link
Messenger