Clinical trial NCT04286867: Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies
Official title: Examining Alcohol Consumption, Perceptions, and User Experience of Alcohol Moderation Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alcohol Abuse
Alcohol Use Disorder
Alcohol Abuse, Episodic
Lead sponsor: Kent State University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups are defined and compared in terms of primary outcome measures.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Young Adult Alcohol Consequences Questionnaire
timeFrame: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline
measure: Number of Standard Drinks Consumed Per Drinking Day
timeFrame: 14 day window preceding baseline assessed at baseline, 14 day window assessed 14 days following baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
References: