Ultrabrief Behavioral Activation for Reducing Alcohol Use (UBA)

• ClinicalTrials.gov Identifier: NCT05086172
• Recruitment Status: Active, not recruiting
• First Posted: October 20, 2021
• Last Update Posted: March 27, 2023
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Use Disorder, Mild; Alcohol Use Disorder, Moderate	Behavioral: Ultrabrief Behavioral Activation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ultrabrief Behavioral Activation for Reducing Alcohol Use
• Actual Study Start Date: March 8, 2022
• Estimated Primary Completion Date: May 10, 2023
• Estimated Study Completion Date: May 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Feasibility via average rate of enrollment of eligible participants [ Time Frame: Through completion of the study, an average of 1 year ]
   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.
2. Feasibility via computed fraction of participants who have completed all assessment in this study [ Time Frame: Baseline up to 3-months Post treatment (Follow up 3) ]
   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)
3. Acceptability via summary scores and statistics of study-designed treatment engagement and acceptability assessment instruments [ Time Frame: 2 weeks Post Treatment (2 week follow-up) ]
   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.

Secondary Outcome Measures :

1. Change in alcohol consumption via average amount of alcohol consumed per drinking day [ Time Frame: 3 months prior to Baseline up to 3-months post treatment ]
   The investigators will compute the change in total alcohol consumption from the three months prior to Baseline up to 3 months post treatment based on the average amount of alcohol consumed per drinking day in the 3 months prior to baseline compared to the average amount of alcohol consumed per drinking day reported in the 3 months post treatment as recorded on the time-line followback (TLFB) in both study arms and assess a pre-treatment, post-treatment difference between groups.
2. Change in alcohol consumption via number of drinking days [ Time Frame: 3 months prior to Baseline up to 3-months post treatment ]
   The investigators will compute the change in total alcohol consumption from the three months prior to Baseline up to 3 months post treatment based on the number of reported drinking days in the 3 months prior to baseline compared to the number of drinking days reported in the 3 months post treatment as recorded on the time-line followback (TLFB) in both study arms and assess a pre-treatment, post-treatment difference between groups.
3. Feasibility via computed fraction of participants that successfully completed at least 1 of each activity independently as per record in treatment booklet [ Time Frame: 2 weeks Post treatment ]
   The investigators will compute the fraction of participants who filled in the treatment booklets in a way that the participants completed at least one of each activity independently at-home (i.e., at least 1 activity and value for at least 3 life areas AND at least 2 alternative activities to alcohol AND at least 1 activity daily for 14 days). This measures feasibility of participants performing work that would be done in-session in longer interventions at home on their own for UBA.
4. Feasibility via the therapist questionnaire (TQ) developed by the investigators for this study [ Time Frame: Immediately following Treatment Session ]
   The investigators will assemble formal feedback from the form for the therapist to fill out (TQ); 3 sub-scores for material covered, acceptance by participant, and participant engagement. The Material Covered subscale ranges from a minimum score of 0 to a maximum score of 10, with higher scores indicating less thorough material coverage. The Acceptance sub-scale ranges from a minimum score of 4 to a maximum score of 20, with higher scores indicating higher levels of acceptance. The Participant Engagement sub-scale ranges from a minimum score of 5 to a maximum score of 25, with higher scores indicating higher levels of participant engagement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27516

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Stacy Daughters, PhD; University of North Carolina, Chapel Hill

More Information

Additional Information:

Principal Investigator's Lab website 

Co-Investigator's Lab Website 

Study Research for Me with study information and links for interested individuals 

Publications:

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• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT05086172
• Other Study ID Numbers: 21-1369
• First Posted: October 20, 2021
• Last Update Posted: March 27, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All individual participant data collected during the trial, after de-identification.
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Disease; Alcoholism; Alcohol Drinking; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders