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By invitation only Not applicable NCT07546604

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

No applicable phase (e.g. observational)
Conditions: Alcohol Prevention Mental Health

Sponsor: Loyola Marymount University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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. \- 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)
Interventions
Gamified Social App Supporting Womens' Health & Well-being
BEHAVIORAL
Psychoeducational Resource Library Access Only
BEHAVIORAL
Locations 1
United States (1)
Loyola Marymount University
Los Angeles , California
Technical details
Status
By invitation only
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
59 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.12.2027
Registry ID
NCT07546604
Source
clinicaltrials.gov
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