Ultrabrief Behavioral Activation for Reducing Alcohol Use (NCT05086172) | Clinical Trial Compass
CompletedNot Applicable
Ultrabrief Behavioral Activation for Reducing Alcohol Use
United States40 participantsStarted 2022-03-08
Plain-language summary
This is a pilot study to assess feasibility, acceptability, and preliminary efficacy of a single-session ("ultrabrief") psychological intervention to reduce alcohol use in participants with mild to moderate alcohol use disorder (AUD). The intervention is a condensed form of the Life Enhancement Treatment for Substance Use (LETS ACT), behavioral activation (BA) for co-morbid depression and substance use. The investigators hypothesize that UBA is feasible and acceptable. The investigators hypothesize that UBA will reduce overall total alcohol consumption as determined by self-report measures capturing drinking behavior for the 3 months prior to treatment versus the 3 months after treatment when compared to an "assessment only" condition.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of mild or moderate alcohol use disorder based on Diagnostic and Statistical Manual-V (DSM-5) criteria
* Age: 18 years or older
Exclusion Criteria:
* Psychotic disorder as determined by the Mini-International Neuropsychiatric Interview (MINI)
* Current suicidality as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
* Diagnosis of severe alcohol or substance use disorder (AUD;SUD) based on MINI
* Receiving concurrent psychotherapy for a mental health-related condition
* Concurrent use of FDA approved medications for the treatment of a substance us disorder
* Change in psychiatric medication in the last four weeks
* The inability to give informed, voluntary, written consent to participate
* Inability to communicate effectively in English as determined by interaction with study personnel
* Anything else that in the assessment of the investigational team is not conducive to successful completion of study requirements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility via average rate of enrollment of eligible participants
Timeframe: Through completion of the study, an average of 1 year
2
Feasibility via computed fraction of participants who have completed all assessment in this study
Timeframe: Baseline up to 3-months Post treatment (Follow up 3)
3
Acceptability via summary scores and statistics of study-designed treatment engagement and acceptability assessment instruments
Timeframe: 2 weeks Post Treatment (2 week follow-up)