Multimodal Sleep Intervention Using Wearable Technology

Not Applicable

Completed

• Conditions: Drinking, Alcohol
• Interventions: Behavioral: Advice; Behavioral: Self-monitoring; Behavioral: Feedback

• Registration Number: NCT03658954
• Lead Sponsor: Yale University

Brief Summary

This research study is examining three different components of a mobile sleep intervention: web-based sleep health advice, sleep and alcohol diary self-monitoring, and personalized sleep and alcohol consumption feedback and tailored coaching. The study is designed to find out which of these components are most effective for mitigating alcohol use disorders and improving sleep health among young adults. The study has three parts: 1) an intake session; 2) a 2-week treatment phase; and 3) three follow-up visits over the next 10 weeks.

Detailed Description

Targeting sleep concerns may be a novel strategy for reducing increased risk of alcohol use disorders in young adults. The current study will develop and test a multimodal mobile intervention addressing sleep concerns in 120 heavy-drinking young adults. All participants will wear sleep and alcohol biosensors daily. Participants will be randomized to one of three interventions. The primary intervention (60 participants) will include web-based sleep health advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback \& tailored coaching. The comparison interventions will be compared to matched control conditions only including these components: (1) web-based sleep health advice (30 participants) or (2) web-based sleep health advice + sleep/alcohol diary self-monitoring (30 participants). The primary objective is to evaluate sleep intervention component feasibility, acceptability, and preliminary efficacy on alcohol outcomes to inform a Stage II randomized trial comparing the final sleep intervention with a standard alcohol intervention.

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-06
• Study Start: 2018-12-07
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2022-12-20
• Results First Submitted QC: 2023-11-10
• Results First Posted: 2023-11-13
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-19
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 18-25 years of age;
2. report ≥ 3 heavy drinking occasions in the last 2 weeks (i.e., ≥5 drinks on 1 occasion for men; ≥4 for women);
3. report having concerns about their sleep;
4. willing/able to complete daily sleep diaries and wear sleep and alcohol trackers;
5. report Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) scores indicative of risk of harm from drinking (i.e., ≥7 and ≥5 for men and women, respectively)
6. read and understand English;
7. have a smartphone

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Exclusion Criteria

1. history of a sleep disorder;
2. night or rotating shift work; travel beyond 2 time zones in month prior and/or planned travel beyond 2 time zones during study participation;
3. meet criteria for an alcohol use disorder in the past 12 months that is clinically severe defined by: a) a history of seizures, delirium, or hallucinations during alcohol withdrawal; b) report drinking to avoid withdrawal symptoms or have had prior treatment of alcohol withdrawal; c) have required medical treatment of alcohol withdrawal in the past 6 months;
4. currently enrolled in alcohol or sleep treatment;
5. exhibit current psychiatric illness (i.e., bipolar disorder, schizophrenia, major depression, panic disorder, borderline personality disorder, organic mood or mental disorders, or suicide or violence risk) by history or psychological examination;
6. current DSM-V substance use disorder or a positive urine drug screen for opiates, cocaine, barbiturates, benzodiazepines, amphetamines, or phencyclidine.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advice	Advice	Participants receive only web-based sleep health advice
Advice + Self-monitoring	Advice	Participants receive web-based sleep health advice + sleep/alcohol diary self-monitoring
Advice + Self-monitoring	Self-monitoring	Participants receive web-based sleep health advice + sleep/alcohol diary self-monitoring
Advice + Self-monitoring + Feedback	Advice	Participants receive web-based sleep health advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback \& tailored coaching
Advice + Self-monitoring + Feedback	Self-monitoring	Participants receive web-based sleep health advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback \& tailored coaching
Advice + Self-monitoring + Feedback	Feedback	Participants receive web-based sleep health advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback \& tailored coaching

Primary Outcome Measures

Name	Time	Method
Total Alcohol Drinks Consumed Over the 12wk Followup	weeks 4 through 12	This will be recorded using the Timeline Follow-back Interview, based on the U.S. Standard Drink Conversion Chart. Upon results entry, the outcome was updated to include the following: data are log-transformed total alcohol drinks consumed over time from Week 4 to Week 12 follow-up, controlling for baseline.

Secondary Outcome Measures

Name	Time	Method
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments	Baseline, week 4, week 8 and week 12	This is a validated, reliable measure of perceived sleep quality/satisfaction and difficulty initiating/maintaining sleep. Upon results entry, the outcome was updated to reflect the following: Sleep Disturbance Score assessed at Week 4, 8 and 12, controlling for baseline. Scores represent standardized T scores with mean of 50 and a standard deviation of 10. Higher scores, 50 and above, equal greater sleep disturbance. Scores 60 and above are clinically significant. Presented is the least squares mean across assessments.
End of Treatment Satisfaction Survey Score	2 weeks	In this survey, participants will rate their satisfaction associated with each intervention component using a 5-point Likert-type scale. Upon results entry, the outcome was corrected to reflect the following: the overall treatment satisfaction uses the mean of questions on a 5-point Likert-type scale from 0 to 4, with higher scores indicating greater satisfaction.
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments	Baseline, week 4, week 8 and week 12	National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score assessed at Week 4, 8, and 12, controlling for baseline. Scores represent standardized T scores with mean of 50 and a standard deviation of 10. Higher scores, 50 and above, equal greater sleep-related impairment. Scores 60 and above are clinically significant. Presented is the least squares mean across assessments.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States