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Ultrabrief Behavioral Activation for Reducing Alcohol Use (UBA)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Alcohol Use Disorder, Moderate
Alcohol Use Disorder, Mild

Treatments

Behavioral: Ultrabrief Behavioral Activation

Study type

Interventional

Funder types

Other

Identifiers

NCT05086172
21-1369

Details and patient eligibility

About

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.

Full description

This is a pilot study to investigate feasibility, acceptability, and preliminary efficacy of an ultrabrief behavioral activation (UBA) intervention for people with a mild to moderate alcohol use disorder. UBA is a psychotherapy intervention derived from the evidence-based LETS ACT BA treatment for substance use disorder. All clinical interviews and the UBA intervention itself will be audio recorded for the purposes of training and to determine reliability and adherence to diagnostic and treatment protocols. No biological samples or signals are collected in this study. The study comprises a phone screening for eligibility, three in-person study visits (initial baseline assessment (BL), UBA intervention session, and 2-week post-treatment assessment) and two follow up phone call assessments (1 month and 3 months after treatment completion). There will be an "assessment only" study arm that will act as a control group which mirrors all aspects of the intervention arm except the "assessment only" arm will receive no intervention. The ultrabrief behavior activation (UBA) intervention is a condensed version of the LETS ACT intervention. The main treatment elements include: (1) explanation of treatment rationale to facilitate behavior change via increased engagement in values-related activities, (2) identification of participant-specific values via detailed assessment of life areas, values and activities, (3) values-based activity planning and scheduling, and (4) post-treatment planning. The overall goal of BA is to shift from values-incongruent behavior (including alcohol use) to behaviors that provide positive reinforcement and environmental reward with the overall goal of increasing the number of engaged-in, value-based activities. This intervention will take 90 minutes. Following intervention completion, therapists will complete a therapist questionnaire and participants will schedule follow-up assessments to occur 2-weeks, 1-month, and 3-months post-treatment. There will be three follow-up contacts with study participants, one in-person visit occurring 2 weeks after the UBA intervention and two phone-based assessments occurring 1 and 3 months following treatment respectively. Follow-up 1 focuses on the treatment experience whereas Follow-up 2 and 3 focus on change in alcohol use and related behaviors and psychological symptoms.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

UBA Arm
Experimental group
Description:
All subjects in this arm will receive ultrabrief behavioral activation therapy via a single, 90-minute session.
Treatment:
Behavioral: Ultrabrief Behavioral Activation
Control Arm
No Intervention group
Description:
All subjects in this arm will complete all study assessment instruments collected in the interventional arm but will not receive an intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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