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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mental Health; Alcohol Prevention
• Intervention / Treatment: Behavioral: Gamified Social App Supporting Womens' Health & Well-being; Behavioral: Psychoeducational Resource Library Access Only

Detailed Description

The app will be advertised as it would be in the real-world as a free, app-based competition designed to test social perceptions, reinforce shared reality, and boost belongingness among biological women. Then, a random sub-sample of new users already engaging with the app (N=1752) will be invited take part in an incentivized sub-study (RCT), consent to participate, and complete a baseline survey. After the survey, they will be block randomized to use either the fully featured app or a limited feature psychoeducational control version during a 3 month intervention period, then complete follow-up surveys immediately following this period, as well as 6 and 9 post-baseline. Simultaneously, the app-related behaviors of 1752 users of the fully featured app NOT invited to take part in the RCT (through random selection when playing their first round) will be observed to address feasibility questions related to app engagement, sustainability of use, and overall acceptability under real-world conditions. As all users consent to use of their basic app data for research purposes at sign-up, those included in feasibility analyses will have no contact with the research team.

• Study Type: Interventional
• Enrollment (Estimated): 1752
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045-2659
      • Loyola Marymount University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

To use the intervention app individuals must:

1. Download the app from the Apple or Android app store
2. Be a biological female
3. Reside in the United States
4. Be 18 years of age or older
5. Accept the Terms of Service & Privacy Policy for the app

Additional RCT Inclusion Criteria

To take part in the study participants must also:

1) Be between 18 and 59 years of age. 2) Receive an on-screen pop-up invitation to take part in the study 2) Review the informed consent information and consent to participate 3) Confirm that they meet app use inclusion criteria.

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Exclusion Criteria for both:

1. Not meeting inclusion criteria
2. Unwillingness to use the app or participate in the study (indicated by failure to accept Terms of Service & Privacy Policy or provide informed consent)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fully featured gamified personalized normative feedback delivering app; 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; 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.
Other: Psychoeducational Resource Library Access Only; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking Norms Rating Form (DNRF)	The Drinking Norms Rating Form (DNRF) is an assessment developed by Baer, Stacy, and Larimer (1991) to measure an individual's perception of peer alcohol consumption (perceived descriptive drinking norm for peer reference group). It follows the structure of the DDQ, where a number of drinks is reported for each day of a typical week during the past month. However, participants are not answering about themselves in this measure and are rather estimating the number of drinks consumed on each day by the typical woman in their age-group (i.e., late teens, 20s, 30s, 40s, 50s).	Assessed at baseline, then at 3, 6, and 9 month follow-ups
UCLA Loneliness Scale	The 3-item UCLA Loneliness Scale, developed by Hughes et al. (2004), is a brief, validated tool for measuring subjective feelings of loneliness and social isolation. It consists of three questions: How often do you feel that you lack companionship? How often do you feel left out? How often do you feel isolated from others? Response Options range from "Hardly ever" (1 point), "Some of the time" (2 points), "Often" (3 points).Total Score: The three items are summed, creating a score ranging from 3 to 9.Interpretation: While various cut-offs exist, a common interpretation is a score of 3-5 as "not lonely" and 6-9 as "lonely".T	Assessed at baseline, then at 3, 6, and 9 month follow-ups
Emotional/Informational Support Sub-scale from the MOS Social Support Scale	Developed by Rand, this self-administered survey sub-scale uses a 5-point Likert scale (none to all of the time) to evaluate the availability of emotional and informational support	Assessed at baseline, then at 3, 6, and 9 month follow-ups

Collaborators and Investigators

• Sponsor: Loyola Marymount University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Sarah C Boyle, PhD, Loyola Marymount University; Principal Investigator: Joseph W. LaBrie, PhD, Loyola Marymount University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mental health; alcohol; women; smartphone app
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Population Characteristics; Health
• Other Study ID Numbers: R01AA031175 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NIMH Data Archive
• IPD Sharing Time Frame: de-identified data will be uploaded to the data archive after all study has been collected
• IPD Sharing Access Criteria: Qualified researchers can access study data via request on the NIMH Data Archive website

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No