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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 sup
• Поведенческое 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.

Первичные конечные точки

• Daily Drinking Questionnaire (DDQ) [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]
• Peak Drinks on One Occasion [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]
• Frequency of Heavy Episodic Drinking [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]
• Alcohol Use Disorders Identification Test (AUDIT) [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]
• Mental Health Inventory (MHI-18) [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]

Вторичные конечные точки (3)

• Drinking Norms Rating Form (DNRF) [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]
• UCLA Loneliness Scale [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]
• Emotional/Informational Support Sub-scale from the MOS Social Support Scale [Срок оценки: Assessed at baseline, then at 3, 6, and 9 month follow-ups]

Критерии участия

Критерии включения

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 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.

Exclusion Criteria for both app and RCT:

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Loyola Marymount University — Los Angeles

Идентификаторы

NCT: NCT07546604 · R01AA031175 · R01AA031175

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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