Multimodal Sleep Intervention Using Wearable Technology
Study Details
Study Description
Brief Summary
This research study is examining three different components of a mobile sleep intervention:
web-based sleep hygiene advice, sleep and alcohol diary self-monitoring, and personalized sleep and alcohol consumption feedback. The study is designed to find out which of these components are most effective for mitigating alcohol use disorders and improving sleep quality 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 mobile intervention addressing sleep concerns in 120 heavy-drinking young adults. All participants will wear sleep and alcohol trackers daily. Participants will be randomized to one of three interventions. The primary intervention (60 participants) will include web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback. The comparison interventions will be compared to matched control conditions only including these components: (1) web-based sleep hygiene advice (30 participants) or (2) web-based sleep hygiene 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Advice Participants receive only web-based sleep hygiene advice |
Behavioral: Advice
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Experimental: Advice + Self-monitoring Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring |
Behavioral: Advice
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Behavioral: Self-monitoring
Participants will complete daily web-based sleep and alcohol diaries for two weeks.
|
Experimental: Advice + Self-monitoring + Feedback Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback |
Behavioral: Advice
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Behavioral: Self-monitoring
Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Behavioral: Feedback
Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
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Outcome Measures
Primary Outcome Measures
- Total alcohol drinks consumed over the 12wk followup [12 weeks]
This will be recorded using the Timeline Follow-back Interview, based on the U.S. Standard Drink Conversion Chart.
Secondary Outcome Measures
- National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance score [12 weeks]
This is a validated, reliable measure of perceived sleep quality/satisfaction and difficulty initiating/maintaining sleep. Scores range from 8 to 40, with lower scores indicating greater sleep disturbance.
- 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. Total scores range from 26 to 130, with higher scores indicating greater satisfaction.
- Stop-signal reaction time [4 weeks]
The difference between the mean reaction time and the stop-signal delay on the stop-signal test
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-25 years of age;
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report ≥ 3 heavy drinking occasions in the last 2 weeks (i.e., ≥5 drinks on 1 occasion for men; ≥4 for women);
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report having concerns about their sleep;
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willing/able to complete daily sleep diaries and wear sleep and alcohol trackers;
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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)
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read and understand English;
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have a smartphone that can be used to sync tracker data. An estimated 86% of young adults own a smartphone.
Exclusion Criteria:
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history of a sleep disorder;
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night or rotating shift work; travel beyond 2 time zones in month prior and/or planned travel beyond 2 time zones during study participation;
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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;
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currently enrolled in alcohol or sleep treatment;
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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;
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current DSM-V substance use disorder or a positive urine drug screen for opiates, cocaine, barbiturates, benzodiazepines, amphetamines, or phencyclidine.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Yale University | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Yale University
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000021048
- R34AA026021