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Brief Family Involved Treatment Telehealth (B-FIT)

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Family-Involved Treatment (B-FIT)
Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy + Brief Family-Involved Treatment

Cognitive Behavioral Therapy

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Family functioning
Change in family functioning as measured by the Brief Family Assessment Measure-III (Brief FAM-III)
Change in Alcohol Consumption
Change in percent days abstinent, as measured by the Alcohol Timeline Followback (TLFB)
Change in percent days drinking
Change in percent days drinking, as measured by the Alcohol Timeline Followback (TLFB)
Change in drinks per drinking day
Change in drinks per drinking day , as measured by the Alcohol Timeline Followback (TLFB)
Alcohol problem severity
Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Change in alcohol craving
Change in alcohol craving as measured by the Penn Alcohol Craving Scale (PACS)

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
March 30, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05674409
Brief Title
Brief Family Involved Treatment Telehealth
Acronym
B-FIT
Official Title
Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder Among Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
March 1, 2028 (Anticipated)
Study Completion Date
March 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy + Brief Family-Involved Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Brief Family-Involved Treatment (B-FIT)
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD)
Intervention Description
Participants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).
Primary Outcome Measure Information:
Title
Family functioning
Description
Change in family functioning as measured by the Brief Family Assessment Measure-III (Brief FAM-III)
Time Frame
From baseline to week 12
Title
Change in Alcohol Consumption
Description
Change in percent days abstinent, as measured by the Alcohol Timeline Followback (TLFB)
Time Frame
From baseline to week 12
Title
Change in percent days drinking
Description
Change in percent days drinking, as measured by the Alcohol Timeline Followback (TLFB)
Time Frame
From baseline to week 12
Title
Change in drinks per drinking day
Description
Change in drinks per drinking day , as measured by the Alcohol Timeline Followback (TLFB)
Time Frame
From baseline to week 12
Title
Alcohol problem severity
Description
Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame
From baseline to week 12
Title
Change in alcohol craving
Description
Change in alcohol craving as measured by the Penn Alcohol Craving Scale (PACS)
Time Frame
From baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Sellers, MS
Phone
843-792-5807
Email
sellersst@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julianne Flanagan, PhD
Phone
843-792-5569
Email
hellmuth@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianne Flanagan, PhD
Phone
843-792-5569
Email
hellmuth@musc.edu
First Name & Middle Initial & Last Name & Degree
Julianne Flanagan, Ph.D

12. IPD Sharing Statement

Learn more about this trial

Brief Family Involved Treatment Telehealth

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