Ultrabrief Behavioral Activation for Reducing Alcohol Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrabrief Behavioral Activation for Reducing Alcohol Use

Conditions
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Alcohol Use Disorder, Mild, Alcohol Use Disorder, Moderate

Intervention / Treatment
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* Behavioral: Ultrabrief Behavioral Activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UBA Arm<br>All subjects in this arm will receive ultrabrief behavioral activation therapy via a single, 90-minute session. | Behavioral: Ultrabrief Behavioral Activation<br>* 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.<br>* Other names: UBA;|
| No Intervention: Control Arm<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alcohol consumption via average amount of alcohol consumed per drinking day | 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 | 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 | 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 | 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 |