Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies

NCT ID: NCT04286867

Last Updated: 2024-11-18

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-05-10

Brief Summary

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The primary aims of the study are to assess the user experience and initial efficacy of a mobile application designed to reduce problematic alcohol use. The application utilizes drinking limits, defined by the user, to pace alcohol consumption during drinking occasions. The mobile application will be compared to strategies for tracking drinking detailed within the National Institute on Alcohol Abuse and Alcoholism Alcohol Moderation Strategies (https://www.rethinkingdrinking.niaaa.nih.gov/thinking-about-a-change/strategies-for-cutting-down/tips-to-try.aspx). Primary outcome variables, in addition to variables assessing user design experience of the application and use of moderation strategies, include (1) negative consequences of alcohol use during a 14 day observation period, and (2) number of drinks consumed per drinking day during a 14 day observation period.

Detailed Description

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The mobile application to be tested provides guidance on moderating alcohol use in real time based on individual user's pre-defined drinking limits. This mobile application will be compared to a drink tracking strategy and corresponding tool outlined within the National Institute on Alcohol Abuse and Alcoholism Alcohol Moderation Strategies (https://www.rethinkingdrinking.niaaa.nih.gov/thinking-about-a-change/strategies-for-cutting-down/tips-to-try.aspx).

Participants will be recruited from the community in Northeastern Ohio. Eligible participants will meet the following inclusion criteria 1) be age 21 or older, 2) report experiencing at least three negative consequence of alcohol use in the past month (assessed via Brief Young Adult Alcohol Consequences Questionnaire: BYAACQ), 3) report having consumed at least 5 drinks (for men) or 4 drinks (for women) on one or more occasions in the past 2-weeks, 4) not be seeking treatment for alcohol use from a health-care provider, and 5) have access to a smartphone and 6) endorse some importance in changing their drinking (2 or greater on Alcohol Ladder Scale Importance to Change). Participants who endorse seeking treatment for alcohol related problems from a health care provider will be provided with a list of university sponsored and community based treatment providers, and excluded. Participants (n=64) will complete a battery of assessments including demographic measures, alcohol and substance use measures, psychological measures, behavioral economic and neuropsychological measures.

The Timeline Follow-back Interview will be used to assess alcohol use. The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ ) will be used to assess a range of negative consequences of alcohol use that young adults may experience (e.g., while drinking in the past month, I have said or done embarrassing things).

Following this initial baseline assessment, participants will be randomized to one of two experimental conditions detailed below (Alcohol Moderation Group 1 and 2). Doctoral Candidates in Clinical Psychology will review strategies for moderating alcohol use with all participants (strategies recommended by the National Institute on Alcohol Abuse and Alcoholism; detail included as supplement). The only variation in the discussion of strategies is the the Alcohol Moderation Group 1 will receive detail and training on how to use the mobile application; whereas, the Alcohol Moderation Group 2 will receive detail and training on how to use the drinking tracker card recommended within the NIAAA guidelines.

Primary outcome variables, in addition to variables assessing user design experience of the application and use of moderation strategies, will include (1) negative consequences of alcohol use during a 14 day observation period following randomization, and (2) number of drinks consumed per drinking day during a 14 day observation period following randomization. Assessment of primary outcome variable (1) will include baseline negative consequences of alcohol use (BYAACQ score) during the 14 day period prior to randomization as a covariate as well as additional covariates defined a priori based on the extant literature. Assessment of primary outcome variable (2) will include consideration of average drinking limit for each drinking day defined by the user, and number of drinks per drinking day in a 14 day period prior to randomization, as well as covariates defined a priori based on the extant literature.

Conditions

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Alcohol Abuse Alcohol Use Disorder Alcohol Abuse, Episodic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups are defined and compared in terms of primary outcome measures.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
All participants are told they will receive information about strategies and tools to reduce alcohol consumption. The participants will not be told whether they are receiving the novel method for reducing alcohol consumption or previously developed and studies methods for reducing alcohol consumption.

Study Groups

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Alcohol Moderation Group 1

This group will receive a link and in-person instructions on how to use the alcohol moderation application described. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

Group Type EXPERIMENTAL

Alcohol Moderation Mobile Application

Intervention Type OTHER

This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

Alcohol Moderation Group 2

This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

Group Type ACTIVE_COMPARATOR

Alcohol Moderation Drink Tracker

Intervention Type BEHAVIORAL

This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

Interventions

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Alcohol Moderation Mobile Application

This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

Intervention Type OTHER

Alcohol Moderation Drink Tracker

This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. must report experiencing at least three negative consequences of alcohol use in the past month (assessed via Brief Young Adult Alcohol Consequences Questionnaire: BYAACQ)
2. have access to a smartphone
3. endorse importance in changing their drinking (2 or greater on Alcohol Ladder Scale Importance to Change)
4. report having consumed at least 5 drinks (for men) or 4 drinks (for women) on one or more occasions in the past 2-weeks

Exclusion Criteria

1. seeking treatment for alcohol use from a health-care provider
2. younger than age 21
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kent State University

OTHER

Sponsor Role lead

Responsible Party

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William Lechner. PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kent State University

Kent, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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18-199

Identifier Type: -

Identifier Source: org_study_id

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