An interventional study of Gamified Social App Supporting Womens' Health & Well-being and Psychoeducational Resource Library Access Only in Alcohol Prevention and Mental Health, sponsored by Loyola Marymount University. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Loyola Marymount University · Not applicable, Interventional, and Prevention
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 69 years of age who signup to use the app and who live in the United States.
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 (treatment) or psychoeducation only (control) during a 3 month intervention period, then complete follow-up surveys immediately following this period, as well as 6 and 9 months later. 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.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 1,752 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →Loyola Marymount University is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To use the intervention app individuals must:
To take part in the RCT participants must also:
Exclusion Criteria for both app and RCT:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at baseline, then at 3, 6, and 9 month follow-ups
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).
Time frame: 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
Time frame: 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
Time frame: Assessed at baseline, then at 3, 6, and 9 month follow-ups
Plan to share: Yes — NIMH Data Archive
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
Data sharing details ↗ · nda.nih.gov
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2027, 20 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 20 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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