Effect of the MyDéfi Smartphone Application on Binge Drinking Among University Students: Protocol of a Double-Blind Multicenter Prospective National Randomized Controlled Trial Using Phosphatidylethanol as a Biomarker—The SMARTBINGE Trial

IF 2.4 3区医学 Q2 PSYCHIATRY

International Journal of Methods in Psychiatric Research Pub Date : 2025-04-01 DOI:10.1002/mpr.70014

Camille André, Pierre Sauton, Méléna Dreinaza, Momar Diouf, Sandra Bodeau, Margaret Martinetti, Raphaël Trouillet, Clara de Groote, Jean-Louis Nandrino, Adèle Alexandre, Farid Benzerouk, Fabien Gierski, Pascal Perney, Laure Grellet, Judith André, Mickael Naassila

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引用次数: 0

Abstract

Objective

The purpose of this paper is to describe a study protocol of a clinical trial exploring the effectiveness of the new mobile application MyDéfi proposing personalized feedback, on both alcohol consumption and quality of life, as well as the blood alcohol exposure biomarker phosphatidylethanol, in university students displaying binge drinking behavior.

Methods

This prospective national multicentric randomized, two-arm (1:1), double-blind controlled trial will recruit 628 students (aged 18–25 years) with binge drinking behavior. Participants will be randomized in the “intervention” group (personalized feedback) or the “control” group (generic feedback) and will undergo four monthly visits. Monthly dried blood spot sample for measuring phosphatidylethanol concentration and online questionnaires will be collected. Our primary objective is to assess the reduction weekly standard drinks, through self-report gathered via MyDéfi. Secondary objectives will evaluate the application's impact on the dosage of phosphatidylethanol blood concentration and on quality of life”.

Results

Recruitment started in March 2024 and will end in March 2026.

Conclusion

This study aims to determine the effectiveness of two versions of the same mobile application (generic vs. personalized feedback) on alcohol consumption in students displaying binge drinking behavior. The effectiveness of the application will be measured, with a secondary objective of quantifying phosphatidylethanol. Our study will open new perspectives on the use of digital interventions for students who do not actively seek treatment.

Trial Registration

Trial registration number (NCT06084832), the date of registration (10th October 2023) and when this was done (16th October 2023). https://clinicaltrials.gov/study/NCT06084832

Abstract Image

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myd智能手机应用程序对大学生酗酒的影响：一项以磷脂酰乙醇为生物标志物的双盲多中心前瞻性国家随机对照试验方案- SMARTBINGE试验

本文的目的是描述一项临床试验的研究方案，该临床试验旨在探索新的移动应用程序myd在酗酒行为大学生的酒精消费和生活质量以及血液酒精暴露生物标志物磷脂酰乙醇方面提出个性化反馈的有效性。方法本前瞻性全国多中心、随机、双盲对照（1:1）试验将招募628名有酗酒行为的学生（18-25岁）。参与者将被随机分为“干预”组（个性化反馈）或“对照组”组（一般反馈），并将接受每月四次的访问。每月收集用于测量磷脂酰乙醇浓度的干血斑样本和在线问卷。我们的主要目标是通过mydsamfi收集的自我报告来评估每周标准饮料的减少。次要目标将评估应用对磷脂酰乙醇血药浓度和生活质量的影响。招募开始于2024年3月，将于2026年3月结束。本研究旨在确定同一移动应用程序的两个版本（通用与个性化反馈）对表现出酗酒行为的学生的酒精消费的有效性。将测量应用程序的有效性，第二个目标是定量磷脂酰乙醇。我们的研究将为那些不积极寻求治疗的学生提供使用数字干预的新视角。试验注册号（NCT06084832）、注册日期（2023年10月10日）和完成时间（2023年10月16日）。https://clinicaltrials.gov/study/NCT06084832

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来源期刊

International Journal of Methods in Psychiatric Research 医学-精神病学

CiteScore

5.20

自引率

6.50%

发文量

审稿时长

>12 weeks

期刊介绍： The International Journal of Methods in Psychiatric Research (MPR) publishes high-standard original research of a technical, methodological, experimental and clinical nature, contributing to the theory, methodology, practice and evaluation of mental and behavioural disorders. The journal targets in particular detailed methodological and design papers from major national and international multicentre studies. There is a close working relationship with the US National Institute of Mental Health, the World Health Organisation (WHO) Diagnostic Instruments Committees, as well as several other European and international organisations. MPR aims to publish rapidly articles of highest methodological quality in such areas as epidemiology, biostatistics, generics, psychopharmacology, psychology and the neurosciences. Articles informing about innovative and critical methodological, statistical and clinical issues, including nosology, can be submitted as regular papers and brief reports. Reviews are only occasionally accepted. MPR seeks to monitor, discuss, influence and improve the standards of mental health and behavioral neuroscience research by providing a platform for rapid publication of outstanding contributions. As a quarterly journal MPR is a major source of information and ideas and is an important medium for students, clinicians and researchers in psychiatry, clinical psychology, epidemiology and the allied disciplines in the mental health field.