Ultrabrief Behavioral Activation for Reducing Alcohol Use

NCT05086172 | Completed

• 1 other identifier: 21-1369
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder, Mild; Alcohol Use Disorder, Moderate

Outcome Measures

Primary Outcomes (3)

• Feasibility via average rate of enrollment of eligible participants

  The investigators will compute the average rate of enrollment of eligible participants when 20 participants have concluded study participation to determine the feasibility of such interventions.

  Through completion of the study, an average of 1 year

• Feasibility via computed fraction of participants who have completed all assessment in this study

  The investigators will compute the fraction of participants who have completed all assessments in this study (baseline, 2-weeks post treatment, 1-month post treatment-3-months post treatment)

  Baseline up to 3-months Post treatment (Follow up 3)

• Acceptability via summary scores and statistics of study-designed treatment engagement and acceptability assessment instruments

  Acceptability will be characterized by computing summary scores and their corresponding statistics from the Treatment Engagement and Acceptability Assessment (TEA) designed for this study. Scores on the TEA range from a minimum score of 20 to a maximum score of 100, with higher scores indicating greater treatment engagement and acceptability.

  2 weeks Post Treatment (2 week follow-up)

Secondary Outcomes (4)

• Change in alcohol consumption via average amount of alcohol consumed per drinking day

  3 months prior to Baseline up to 3-months post treatment

• Change in alcohol consumption via number of drinking days

  3 months prior to Baseline up to 3-months post treatment

• Feasibility via computed fraction of participants that successfully completed at least 1 of each activity independently as per record in treatment booklet

  2 weeks Post treatment

• Feasibility via the therapist questionnaire (TQ) developed by the investigators for this study

  Immediately following Treatment Session

Study Arms (2)

UBA Arm

EXPERIMENTAL

All subjects in this arm will receive ultrabrief behavioral activation therapy via a single, 90-minute session.

Behavioral: Ultrabrief Behavioral Activation

Control Arm

NO INTERVENTION

All subjects in this arm will complete all study assessment instruments collected in the interventional arm but will not receive an intervention.

Interventions

Ultrabrief Behavioral Activation BEHAVIORAL

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 behavioral activation (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.

Also known as: UBA

UBA Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of mild or moderate alcohol use disorder based on Diagnostic and Statistical Manual-V (DSM-5) criteria
• Age: 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

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Related Links

• Co-Investigator's Lab Website
• Study Research for Me with study information and links for interested individuals

MeSH Terms

Conditions

Alcoholism; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Stacy Daughters, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 20, 2021
• Study Start: March 8, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication without expiry.
• Access Criteria: Researchers requesting the use of the provided de-identified data should direct inquiries to Stacey Daughters (daughter@unc.edu) and should have received approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.

Locations

US (1)