A Multimodal Mobile Sleep Intervention for Young Adults Engaged in Risky Drinking: Protocol for a Randomized Controlled Trial.

BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03658954; https://clinicaltrials.gov/ct2/show/NCT03658954. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26557. ©Lisa M Fucito, Garrett I Ash, Kelly S DeMartini, Brian Pittman, Nancy P Barnett, Chiang-Shan R Li, Nancy S Redeker, Stephanie S O'Malley. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.02.2021.

RCT Entities:   Population Interventions Outcomes