Fucito Lisa M, Ash Garrett I, DeMartini Kelly S, Pittman Brian, Barnett Nancy P, Li Chiang-Shan R, Redeker Nancy S, O'Malley Stephanie S
Department of Psychiatry, Yale University School of Medicine, New Haven, CT, United States.
Yale Cancer Center, New Haven, CT, United States.
JMIR Res Protoc. 2021 Feb 26;10(2):e26557. doi: 10.2196/26557.
This paper describes the research protocol for a randomized controlled trial of a multimodal mobile sleep intervention for heavy-drinking young adults. Young adults report the highest rates of heavy, risky alcohol consumption and are a priority population for alcohol prevention and intervention efforts. Alcohol strategies that leverage other health concerns and use technology may offer an innovative solution. Poor sleep is common among young adults and is a risk factor for developing an alcohol use disorder. Moreover, young adults are interested in information to help them sleep better, and behavioral sleep interventions address alcohol use as a standard practice.
The primary aim of this study is to assess the effectiveness of a 2-week multimodal mobile sleep intervention for reducing drinks consumed per week among heavy-drinking young adults. We will explore the effects on alcohol-related consequences, assessing quantitative and qualitative sleep characteristics as secondary aims. The study's goals are to identify the optimal combination of sleep intervention components for improving drinking outcomes, the feasibility and acceptability of these components, and the potential mechanisms by which these components may promote alcohol behavior change.
Young adults (aged 18-25 years) who report recent heavy drinking will be randomly assigned to one of three conditions: mobile sleep hygiene advice (n=30), mobile sleep hygiene advice and sleep and alcohol diary self-monitoring (n=30), or mobile sleep hygiene advice, sleep and alcohol diary self-monitoring, and sleep and alcohol data feedback (n=60). For the feedback component, participants will complete two web-based sessions with a health coach during which they will receive summaries of their sleep and alcohol data, and the potential association between them along with brief advice tailored to their data. All participants will wear sleep and alcohol biosensors daily for 2 weeks for objective assessments of these outcomes.
The study was funded by the National Institutes of Health in May 2018. Recruitment began in December 2018 and will be concluded in Spring 2021. As of February 4, 2021, we have enrolled 110 participants.
Ultimately, this research could result in an efficacious, low-cost intervention with broad population reach through the use of technology. In addition, this intervention may substantially impact public health by reducing alcohol use disorder risk at a crucial developmental stage.
ClinicalTrials.gov NCT03658954; https://clinicaltrials.gov/ct2/show/NCT03658954.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26557.
本文描述了一项针对重度饮酒的年轻成年人的多模式移动睡眠干预随机对照试验的研究方案。年轻成年人报告的重度、危险饮酒率最高,是酒精预防和干预工作的重点人群。利用其他健康问题并采用技术的酒精干预策略可能提供一种创新解决方案。睡眠不佳在年轻成年人中很常见,并且是发展酒精使用障碍的一个风险因素。此外,年轻成年人对有助于他们更好睡眠的信息感兴趣,并且行为睡眠干预将解决饮酒问题作为一种标准做法。
本研究的主要目的是评估为期2周的多模式移动睡眠干预对减少重度饮酒的年轻成年人每周饮酒量的有效性。我们将探索对与酒精相关后果的影响,评估定量和定性睡眠特征作为次要目的。该研究的目标是确定改善饮酒结果的睡眠干预组成部分的最佳组合、这些组成部分的可行性和可接受性,以及这些组成部分可能促进酒精行为改变的潜在机制。
报告近期重度饮酒的年轻成年人(年龄在18 - 25岁之间)将被随机分配到三种情况之一:移动睡眠卫生建议(n = 30)、移动睡眠卫生建议以及睡眠和酒精日记自我监测(n = 30),或移动睡眠卫生建议、睡眠和酒精日记自我监测以及睡眠和酒精数据反馈(n = 60)。对于反馈部分,参与者将与健康教练完成两个基于网络的课程,在此期间他们将收到睡眠和酒精数据的摘要,以及它们之间的潜在关联,同时还会收到根据他们的数据量身定制的简短建议。所有参与者将连续2周每天佩戴睡眠和酒精生物传感器,以对这些结果进行客观评估。
该研究于2018年5月由美国国立卫生研究院资助。招募工作于2018年12月开始,将于2021年春季结束。截至2021年2月4日,我们已招募了110名参与者。
最终,这项研究可能会通过使用技术产生一种有效、低成本且能广泛惠及人群的干预措施。此外,这种干预措施可能通过在关键发育阶段降低酒精使用障碍风险,对公共卫生产生重大影响。
ClinicalTrials.gov NCT03658954;https://clinicaltrials.gov/ct2/show/NCT03658954。
国际注册报告标识符(IRRID):DERR1 - 10.2196/26557。