Alcohol Prevention, Mental Health
Conditions
Keywords
alcohol, mental health, women, smartphone app
Brief 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.
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.
Interventions
BEHAVIORALGamified 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 supportive articles written by experts in womens' health and well-being.
BEHAVIORALPsychoeducational 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.
Sponsors
Loyola Marymount University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Drinking Questionnaire (DDQ) | 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 | 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 | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drinking Norms Rating Form (DNRF) | Assessed at baseline, then at 3, 6, and 9 month follow-ups | 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). |
| UCLA Loneliness Scale | Assessed at baseline, then at 3, 6, and 9 month follow-ups | 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 |
| Emotional/Informational Support Sub-scale from the MOS Social Support Scale | Assessed at baseline, then at 3, 6, and 9 month follow-ups | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah C Boyle, PhD
Loyola Marymount University
PRINCIPAL_INVESTIGATORJoseph W. LaBrie, PhD
Loyola Marymount University
Outcome results
None listed