Brief Family Involved Treatment Telehealth

NCT ID: NCT05674409

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2029-03-01

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.

Detailed Description

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).

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy + Brief Family-Involved Treatment

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 Type: EXPERIMENTAL

Brief Family-Involved Treatment (B-FIT)

Intervention Type: BEHAVIORAL

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.

Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)

Intervention Type: BEHAVIORAL

Participants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).

Cognitive Behavioral Therapy

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).

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)

Intervention Type: BEHAVIORAL

Participants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).

Interventions

Brief Family-Involved Treatment (B-FIT)

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.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)

Participants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).

Intervention Type: BEHAVIORAL

Eligibility 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.

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.

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

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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Julianne Flanagan

Associate Professor, Licensed Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stacey Sellers, MS

Role: CONTACT

sellersst@musc.edu

843-792-5807

Julianne Flanagan, PhD

Role: CONTACT

hellmuth@musc.edu

843-792-5569

Facility Contacts

Julianne Flanagan, PhD

Role: primary

hellmuth@musc.edu

843-792-5569

Other Identifiers

R01AA029679

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00121552

Identifier Type: -

Identifier Source: org_study_id