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Alcohol PreventionNCT07546604

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

A study testing Gamified Social App Supporting Womens' Health & Well-being and Psychoeducational Resource Library Access Only in people with Alcohol Prevention and Mental Health, run by Loyola Marymount University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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 69 years of age who signup to use the app and who live in the United States. Read more about this study

Who is it for?
Ages 18 to 69 years, women onlyHealthy volunteers can take part
Conditions the study is for
Alcohol Prevention, Mental Health
What is being tested?
Gamified Social App Supporting Womens' Health & Well-being and Psychoeducational Resource Library Access Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,752 participants
Where
1 siteUnited States
Study dates
1 Apr 2026to 20 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • To take part in the RCT participants must also:
  • Be between 18 and 69 years of age.
  • Receive an on-screen pop-up invitation to take part in the study
  • Review the informed consent information and consent to participate
  • Confirm that they meet app use inclusion criteria.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Loyola Marymount University

    Los Angeles, California, 90045-2659

Other trials in United States

About this study

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.

Read the 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 (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.

Being tested
Gamified Social App Supporting Womens' Health & Well-being, Psychoeducational Resource Library Access Only
Keywords
alcohol, mental health, women, smartphone app
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamified Social App Supporting Womens' Health & Well-beingBehavioural

    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.

  • Psychoeducational Resource Library Access OnlyBehavioural

    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.

Study groups in NCT07546604
Study groupRoleWhat they receive
Fully featured gamified personalized normative feedback delivering appExperimentalParticipants 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.
Receives: Behavioral: Gamified Social App Supporting Womens' Health & Well-being
Psychoeducational Resource Library Access OnlyOtherParticipants 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.
Receives: Behavioral: Psychoeducational Resource Library Access Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (3)

  1. 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).

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

  2. 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

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 Apr 2026
  3. Primary completion20 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,752 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07546604
Sponsor's protocol ID
R01AA031175
Other IDs
R01AA031175
Status last verified
Jul 2026
First submitted
15 Apr 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NIMH Data Archive

Questions about this trial

What is this clinical trial studying?

A study testing Gamified Social App Supporting Womens' Health & Well-being and Psychoeducational Resource Library Access Only in people with Alcohol Prevention and Mental Health, run by Loyola Marymount University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Drinking Questionnaire (DDQ) (time frame: Assessed at baseline, then at 3, 6, and 9 month follow-ups). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07546604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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