Clinical trial NCT05086172: Ultrabrief Behavioral Activation for Reducing Alcohol Use
Official title: Ultrabrief Behavioral Activation for Reducing Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder, Mild
Alcohol Use Disorder, Moderate
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an early pilot study that will compare an interventional assignment group to an "assessment only" control. The focus is on feasibility and acceptance of such a short intervention. The intervention is an ultrabrief, single-session (90 minute) administration of UBA, a psychotherapy intervention derived from the evidence-based LETS ACT Behavioral Activation treatment for substance use disorder. However, the investigators will also measure the difference of change in alcohol use behavior between groups as an additional outcome to gain an initial understanding of the magnitude of the effect for the design of future controlled studies.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility via average rate of enrollment of eligible participants
timeFrame: Through completion of the study, an average of 1 year
measure: 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)
measure: Acceptability via summary scores and statistics of study-designed treatment engagement and acceptability assessment instruments
timeFrame: 2 weeks Post Treatment (2 week follow-up)
Secondary outcomes:
measure: Change in alcohol consumption via average amount of alcohol consumed per drinking day
timeFrame: 3 months prior to Baseline up to 3-months post treatment
measure: Change in alcohol consumption via number of drinking days
timeFrame: 3 months prior to Baseline up to 3-months post treatment
measure: Feasibility via computed fraction of participants that successfully completed at least 1 of each activity independently as per record in treatment booklet
timeFrame: 2 weeks Post treatment
measure: Feasibility via the therapist questionnaire (TQ) developed by the investigators for this study
timeFrame: Immediately following Treatment Session
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stacy Daughters, PhD
role: PRINCIPAL_INVESTIGATOR
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