Feasibility and Effectiveness of Gamified Digital Intervention to Prevent Alcohol and Mental Health Risks
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,752
- 试验地点
- 1
- 主要终点
- Daily Drinking Questionnaire (DDQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Daily Drinking Questionnaire (DDQ)
时间窗: Assessed at baseline, then at 3, 6, and 9 month follow-ups
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".
Peak Drinks on One Occasion
时间窗: Assessed at baseline, then at 3, 6, and 9 month follow-ups
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.
Frequency of Heavy Episodic Drinking
时间窗: Assessed at baseline, then at 3, 6, and 9 month follow-ups
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.
Alcohol Use Disorders Identification Test (AUDIT)
时间窗: Assessed at baseline, then at 3, 6, and 9 month follow-ups
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.
Mental Health Inventory (MHI-18)
时间窗: Assessed at baseline, then at 3, 6, and 9 month follow-ups
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.
次要结局
- Drinking Norms Rating Form (DNRF)(Assessed at baseline, then at 3, 6, and 9 month follow-ups)
- UCLA Loneliness Scale(Assessed at baseline, then at 3, 6, and 9 month follow-ups)
- Emotional/Informational Support Sub-scale from the MOS Social Support Scale(Assessed at baseline, then at 3, 6, and 9 month follow-ups)
研究者
Dr. Joseph LaBrie
Professor of Psychology
Loyola Marymount University