Family Therapy for Alcoholism via Telehealth

(B-FIT Trial)

Overseen By Julianne Flanagan, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must be taking: Psychotropic medications

Disqualifiers: Psychotic, Bipolar, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, Brief Family-Involved Treatment (B-FIT), can assist veterans with alcohol use disorder (AUD) when combined with regular therapy. Veterans with moderate to severe AUD who have experienced heavy drinking days in the past two months might be suitable candidates. The trial will compare veterans receiving B-FIT alongside Cognitive Behavioral Therapy (CBT) to those receiving only CBT. Participants will engage in weekly check-ins and follow-up assessments via telehealth. The study seeks to make family-based treatment more accessible and effective for veterans facing alcohol issues. As an unphased trial, it offers veterans a unique opportunity to contribute to innovative treatment approaches for AUD.

Will I have to stop taking my current medications?

The trial requires that participants maintain a stable dose of psychotropic medications for at least 4 weeks before enrollment, so you should not stop taking your current medications if they are stable.

What prior data suggests that this family therapy protocol is safe for Veterans?

Past studies have shown that involving family members in alcohol use disorder treatment leads to positive results. Brief Family-Involved Treatment (B-FIT), consisting of just three sessions, reduced the number of days patients drink. This suggests that B-FIT is well-received and potentially effective.

Cognitive Behavioral Therapy (CBT) for alcohol use disorder has proven safe and effective in many studies. Participants in these studies generally reported positive experiences with CBT, a well-researched and established method for treating substance use disorders.

In this study, both B-FIT and CBT are delivered through telehealth, offering convenience without compromising safety. Overall, both treatments are considered safe, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine traditional Cognitive Behavioral Therapy (CBT) for Alcohol Use Disorder with a novel, family-focused approach called Brief Family-Involved Treatment (B-FIT), all delivered through telehealth. Unlike standard treatments that often focus solely on the individual, B-FIT involves family members, aiming to strengthen support systems and improve outcomes. This dual approach could potentially enhance the effectiveness of CBT by adding a family dynamic, which is a unique feature not typically seen in current alcohol use disorder therapies. Plus, the use of telehealth makes these treatments more accessible to those who might otherwise face barriers to in-person therapy.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder?

Research shows that involving family members in treating alcohol use disorder (AUD) can lead to better results. In this trial, one group of participants will receive Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD) alone, while another group will receive CBT for AUD combined with a new 3-session program called B-FIT, which includes family members. B-FIT has shown promise in reducing the number of days patients with AUD drink. Studies of B-FIT, delivered through online video sessions, have successfully involved families in the treatment process. Early findings suggest that B-FIT, when used alongside standard treatments like CBT, may improve treatment success for veterans with AUD. Overall, initial evidence supports the potential of B-FIT to help reduce alcohol consumption. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a veteran aged 21 or older, and I have a family member or friend who will join me.

Veterans must have an adult family member/treatment companion who is willing to participate

Family members/treatment companions must report total Alcohol Use Disorders Identification Test (AUDIT) scores <8

Exclusion Criteria

History of or current psychotic or bipolar disorder

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of Cognitive Behavioral Therapy (CBT) for Alcohol Use Disorder, with an additional 3 sessions of Brief Family-Involved Treatment (B-FIT) for those in the experimental group

12 weeks

Weekly telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months

6 months

2 follow-up assessments via telehealth

What Are the Treatments Tested in This Trial?

Interventions

• Brief Family-Involved Treatment (B-FIT)
• Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy + Brief Family-Involved Treatment Experimental Treatment 2 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 Therapy Active Control 1 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).

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Behavioral couples therapy (BCT) combined with individual-based therapy (IBT) was found to be more effective than IBT alone for women with alcohol use disorder (AUD), leading to higher rates of abstinence and fewer substance-related problems over a 1-year follow-up with 105 participants.

BCT also improved relationship satisfaction for male partners and significantly reduced intimate partner violence, highlighting its benefits not only for substance use but also for enhancing relationship dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of behavioral couples therapy versus individually based treatment for women with alcohol dependence. Schumm, JA., O'Farrell, TJ., Kahler, CW., et al.[2021]

A study involving 55 patients with alcohol use disorder showed that interactive, personalized computer-based cognitive behavioral therapy (CBT) was effective, leading to significant reductions in alcohol consumption and increased abstinence rates over a 3-month follow-up.

Both the computer-based CBT and placebo groups improved in their drinking outcomes, but the CBT group showed greater engagement in Alcoholics Anonymous and better self-efficacy regarding alcohol use, suggesting that computer-based CBT could be a valuable tool in treating AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for alcohol use disorder: a pilot randomised control trial. Farren, CK., Milnes, J., Lambe, K., et al.[2019]

A study involving 68 individuals with alcohol use disorders showed that those receiving web-based cognitive behavioral therapy (CBT4CBT) had significantly higher treatment completion rates and greater increases in the percentage of days abstinent compared to standard treatment alone.

The web-based CBT4CBT program was found to be safe and feasible, with preliminary evidence suggesting it may reduce the costs of alcohol use disorder-related services compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Kiluk, BD., Devore, KA., Buck, MB., et al.[2018]

Both Behavioral Couples Therapy (BCT) and Cognitive-Behavioral Therapy (CBT) were effective in reducing alcohol consumption among participants, with no significant superiority of BCT over CBT in terms of drinking behavior.

BCT significantly improved marital satisfaction for partners of alcoholics, while CBT did not show this benefit, although BCT was more time-consuming and costly due to longer session durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual cognitive-behavioral therapy and behavioral couples therapy in alcohol use disorder: a comparative evaluation in community-based addiction treatment centers. Vedel, E., Emmelkamp, PM., Schippers, GM.[2018]

In a study involving 101 patients with alcohol dependence and their partners, the new Group Behavioral Couples Therapy (G-BCT) format showed significantly worse substance use and relationship outcomes compared to the Standard Behavioral Couples Therapy (S-BCT) format over a 1-year follow-up.

The results indicated that while S-BCT maintained improvements in outcomes, G-BCT experienced a deterioration in effectiveness during the last 6-9 months, suggesting that G-BCT may not be a suitable alternative to S-BCT for couples dealing with alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of group versus standard behavioral couples therapy plus individually based treatment for patients with alcohol dependence. O'Farrell, TJ., Schumm, JA., Dunlap, LJ., et al.[2018]

The Remote Brief Intervention and Referral to Treatment (R-BIRT) model was found to be feasible, with a 40% acceptance rate among 125 eligible emergency department patients, indicating potential for wider implementation.

Patients who received consultations during their emergency department visit had a significantly higher completion rate of 90% compared to only 10% for those contacted after their visit, suggesting that immediate intervention may enhance engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. Boudreaux, ED., Haskins, B., Harralson, T., et al.[2018]

A modified 3-session family-involved treatment called B-FIT showed promising results in reducing drinking days among patients with alcohol use disorder, with a large effect size (Hedges' g = 1.01) reported by patients.

Despite challenges in implementation, the preliminary data suggest that B-FIT could be a valuable addition to inpatient treatment programs for alcohol use disorder, although family support and functioning measures did not show significant improvement compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot trial of brief family-involved treatment for alcohol use disorder: Treatment engagement and outcomes. McCrady, BS., Tonigan, JS., Fink, BC., et al.[2023]

Behavioral couples therapy (BCT) is effective for both dual problem couples (where both partners have alcohol use disorder) and single problem couples (where only one partner has AUD), as shown in a study comparing 20 dual problem couples to 386 single problem couples.

The degree of improvement in abstinence rates after BCT was similar for both types of couples, indicating that BCT can be a viable treatment option regardless of whether one or both partners are struggling with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Couples Therapy When Both Partners Have a Current Alcohol Use Disorder. Schumm, JA., O'Farrell, TJ., Andreas, JB.[2021]

Couple therapy, specifically Alcohol Behavioral Couple Therapy (ABCT), has been shown to effectively reduce alcohol consumption and improve relationship satisfaction in individuals with alcohol use disorders, as demonstrated in a case study involving a 42-year-old woman and her husband over 12 sessions in 6 months.

The therapy helped the woman achieve abstinence from alcohol while equipping her husband with skills to support her recovery, highlighting the importance of mutual support and communication in overcoming alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating alcohol problems with couple therapy. McCrady, BS.[2012]

Citations

1. psycnet.apa.org psycnet.apa.org/record/2023-54059-001

A randomized pilot trial of brief family-involved treatment for ... Objective: Involving family members in a patient's treatment for alcohol use disorder (AUD) leads to more positive outcomes, but evidence-based ...

2. reporter.nih.gov reporter.nih.gov/search/f4XhO_EEUkSiDebr6xAD-A/project-details/10893390

Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved ... This study will address longstanding gaps in the literature by examining the efficacy of Brief Family Involved Treatment (B-FIT), delivered via telehealth (i.e. ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05545644?term=AREA%5BConditionSearch%5D(Alcohol%20Use%20Disorder)&rank=3

Brief Family-involved Treatment for Alcohol Use Disorder It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4. reporter.nih.gov reporter.nih.gov/search/DpgbYX5wEkmMneI3rA2lgg/project-details/11141696

RePORT RePORTER - National Institutes of Health (NIH) | Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder among Veterans. Project Number5R01AA029679 ...

5. withpower.com withpower.com/trial/phase-alcoholism-2-2023-97268

Family Therapy for Alcoholism via Telehealth (B-FIT Trial) A modified 3-session family-involved treatment called B-FIT showed promising results in reducing drinking days among patients with alcohol use disorder, with a ...

6. reporter.nih.gov reporter.nih.gov/project-details/10924029

Project Details - NIH RePORTER Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder among Veterans. 780, 5R01AA029679-04Project ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05674409?tab=table

Brief Family Involved Treatment Telehealth (B-FIT) Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... These trials gather additional information about a drug's safety, efficacy, or optimal ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36931829/

A randomized pilot trial of brief family-involved treatment for ... Objective: Involving family members in a patient's treatment for alcohol use disorder (AUD) leads to more positive outcomes, ...