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
NCT Number: NCT05674409
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29401, United States
Location status: Recruiting
Julianne Flanagan, Ph.D
PRINCIPAL_INVESTIGATOR
Julianne Flanagan, PhD
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for Veterans require that they:
Inclusion criteria
for the family member/treatment companion require that they:
Exclusion criteria
Exclusion criteria
for all participants include:
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.
Participants will receive 12 sessions of Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT for AUD).
Time frame: From baseline to week 12
Change in family functioning as measured by the Brief Family Assessment Measure-III (Brief FAM-III)
Time frame: From baseline to week 12
Change in percent days abstinent, as measured by the Alcohol Timeline Followback (TLFB)
Time frame: From baseline to week 12
Change in percent days drinking, as measured by the Alcohol Timeline Followback (TLFB)
Time frame: From baseline to week 12
Change in drinks per drinking day , as measured by the Alcohol Timeline Followback (TLFB)
Time frame: From baseline to week 12
Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Time frame: From baseline to week 12
Change in alcohol craving as measured by the Penn Alcohol Craving Scale (PACS)
Contact information is provided by the study sponsor or research team.
Julianne Flanagan, PhD
CONTACT
Stacey Sellers, MS
CONTACT
Medical University of South Carolina
Other
Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder Among Veterans
Acronym: B-FIT
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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