RECRUITING

Brief Family Involved Treatment Telehealth

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-13

Study Completion:2029-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05674409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Study Contact

Stacey Sellers, MS

CONTACT

843-792-5807

sellersst@musc.edu

Julianne Flanagan, PhD

CONTACT

843-792-5569

hellmuth@musc.edu

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29401

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13

Study Completion Date2029-03-01

Study Record Updates

Study Start Date2023-03-13

Study Completion Date2029-03-01

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder