Brief Family Involved Treatment Telehealth (NCT05674409) | Clinical Trial Compass
RecruitingNot Applicable
Brief Family Involved Treatment Telehealth
United States400 participantsStarted 2023-03-13
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
✕. 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).