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NCT Number: NCT05674409

Brief Family Involved Treatment Telehealth

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location status: Recruiting

Location contact

Julianne Flanagan, Ph.D

PRINCIPAL_INVESTIGATOR

Julianne Flanagan, PhD

CONTACT

[email protected]

843-792-5569

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Inclusion criteria

for the family member/treatment companion require that they:

  • 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.

Exclusion criteria

Exclusion criteria

for all participants include:

  • 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).

Treatment and study plan

Brief Family-Involved Treatment (B-FIT)

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)

Behavioral

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

Primary outcomes

  1. Family functioning

    Time frame: From baseline to week 12

    Change in family functioning as measured by the Brief Family Assessment Measure-III (Brief FAM-III)

  2. Change in Alcohol Consumption

    Time frame: From baseline to week 12

    Change in percent days abstinent, as measured by the Alcohol Timeline Followback (TLFB)

  3. Change in percent days drinking

    Time frame: From baseline to week 12

    Change in percent days drinking, as measured by the Alcohol Timeline Followback (TLFB)

  4. Change in drinks per drinking day

    Time frame: From baseline to week 12

    Change in drinks per drinking day , as measured by the Alcohol Timeline Followback (TLFB)

  5. Alcohol problem severity

    Time frame: From baseline to week 12

    Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT)

  6. Change in alcohol craving

    Time frame: From baseline to week 12

    Change in alcohol craving as measured by the Penn Alcohol Craving Scale (PACS)

Study contacts

Contact information is provided by the study sponsor or research team.

Julianne Flanagan, PhD

CONTACT

[email protected]

843-792-5569

Stacey Sellers, MS

CONTACT

[email protected]

843-792-5807

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder Among Veterans

Acronym: B-FIT

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jan 6, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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