Ultrabrief Behavioral Activation for Reducing Alcohol Use (UBA)

July 24, 2023 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through completion of the study, an average of 1 year
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)
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
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.
2 weeks Post Treatment (2 week follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months prior to Baseline up to 3-months post treatment
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 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
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.
2 weeks Post treatment
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.
Immediately following Treatment Session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stacy Daughters, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-1369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data collected during the trial, after de-identification.

IPD Sharing Time Frame

Immediately following publication without expiry.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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