Feasibility and Effectiveness of Gamified Digital Intervention to Prevent Alcohol and Mental Health Risks

NCT07546604 | Enrolling By Invitation

• 1 other identifier: R01AA031175
• Study Type: interventional
• Target: 1,752
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of a novel smartphone application on alcohol consumption, alcohol-related problems, and psychological well-being. Participants invited into the study are biological females between the ages of 18 and 59 years of age who signup to use the app and who live in the United States.

Conditions

Alcohol Prevention; Mental Health

Keywords

alcohol; mental health; women; smartphone app

Outcome Measures

Primary Outcomes (5)

• Daily Drinking Questionnaire (DDQ)

  The Daily Drinking Questionnaire (DDQ) is a self-report tool measuring alcohol consumption by asking individuals to estimate the number of standard drinks consumed on each day of a typical week. Developed by Collins, Parks, and Marlatt (1985), the version used in this trial specified "a typical week during the past month".

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

• Peak Drinks on One Occasion

  This is a single item from the Quantity, Frequency, Max (QFM) Measure of alcohol consumption. It asks the participant to report the number of drinks consumed on their heaviest drinking occasion during the past 30 days.

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

• Frequency of Heavy Episodic Drinking

  This is a single item from the Quantity, Frequency, Max (QFM) Measure of alcohol consumption. It asks the participant to report how many times during the past month they consumed 4 or more drinks within a few hours.

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

• Alcohol Use Disorders Identification Test (AUDIT)

  The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item, World Health Organization-developed screening tool used by clinicians to identify hazardous drinking, harmful consumption, or alcohol dependence. It covers alcohol consumption frequency, symptoms of dependence, and personal/social consequences, with scores of 8+ indicating increasing risk.

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

• Mental Health Inventory (MHI-18)

  The Mental Health Inventory (MHI) provides a structured and standardized assessment of an individual's psychological adjustment across multiple dimensions (anxiety, depression, behavioral control, positive affect, and general distress) via a total of 18 scale items. It aims to quantify the degree of mental health stability, allowing clinicians and researchers to identify areas of strength and potential vulnerability in an individual's adaptive responses.

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

Secondary Outcomes (3)

• Drinking Norms Rating Form (DNRF)

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

• UCLA Loneliness Scale

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

• Emotional/Informational Support Sub-scale from the MOS Social Support Scale

  Assessed at baseline, then at 3, 6, and 9 month follow-ups

Study Arms (2)

Fully featured gamified personalized normative feedback delivering app

EXPERIMENTAL

Participants randomized to this arm are invited to use the fully featured app for a period of 3 months between March and December 2026 (Heat 1). The app includes interactive social community features and delivers gamified personalized normative feedback (PNF) on a weekly basis designed to correct misperceived norms for alcohol use, coping behaviors, other health behaviors, and other experiences of interest to this population (relationships, etc). The app also has a psychoeducational resource library containing health and mental health supportive articles and PNF screens also link to psychoeducational resource pages on corresponding topics.

Behavioral: Gamified Social App Supporting Womens' Health & Well-being

Psychoeducational Resource Library Access Only

OTHER

Participants randomized to this arm are assigned to Heat 2 where their app use is delayed by 12 months. During Heat 1 (March-December 2026), they are locked out of the app and only have access to a web version of the psychoeducational resource library.

Behavioral: Psychoeducational Resource Library Access Only

Interventions

Gamified Social App Supporting Womens' Health & Well-being BEHAVIORAL

The gamified social app supporting womens' health and well-being delivers weekly gamified personalized normative feedback on questions about alcohol use, stress coping behaviors, other health behaviors, and mental health experiences, in the context of a social guessing game about peers. The app also includes an interactive social community (browsable profiles, social feed allowing users to post, like, comment, and discuss), and a supportive psychoeducational resource library that contains 35 supportive articles written by experts in womens' health and well-being.

Fully featured gamified personalized normative feedback delivering app

Psychoeducational Resource Library Access Only BEHAVIORAL

This is a web version of the app's psychoeducational resource library containing 35 articles written by experts in womens' physical and mental health. The article library is identical to what is available inside the app.

Psychoeducational Resource Library Access Only

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To use the intervention app individuals must:
• Download the app from the Apple or Android app store
• Be a biological female
• Reside in the United States
• Be 18 years of age or older
• Accept the Terms of Service \& Privacy Policy for the app
• To take part in the study participants must also:

You may not qualify if:

• Unwillingness to use the app or participate in the study (indicated by failure to accept Terms of Service \& Privacy Policy or provide informed consent)

Sponsors & Collaborators

• Loyola Marymount University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Loyola Marymount University

Los Angeles, California, 90045-2659, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Health

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Sarah C Boyle, PhD

  Loyola Marymount University

  PRINCIPAL INVESTIGATOR

• Joseph W. LaBrie, PhD

  Loyola Marymount University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: de-identified data will be uploaded to the data archive after all study has been collected
• Access Criteria: Qualified researchers can access study data via request on the NIMH Data Archive website

Locations

US (1)