This research study is examining three different components of a digital sleep intervention: web-based sleep health advice, sleep and alcohol smartphone diary self-monitoring, and personalized sleep and alcohol consumption feedback from wearables/diaries and tailored coaching. The study is designed to find out which of these components are most effective for reducing alcohol use 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.
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 digital 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 smartphone diary self-monitoring + sleep/alcohol data wearable/diary 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 smartphone diary self-monitoring (30 participants). The primary objective is to evaluate sleep intervention component feasibility, acceptability, and preliminary efficacy on alcohol and sleep outcomes to inform a large scale Stage II randomized trial comparing the final digital intervention against standard care for this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep health advice.
Participants will complete daily smartphone-based sleep and alcohol diaries for two weeks.
Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Philips actiwatches and SCRAM ankle biosensors \& smartphone diaries \& tailored coaching with a health coach
Yale University
New Haven, Connecticut, United States
Total Alcohol Drinks Consumed Over the 12wk Followup
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.
Time frame: weeks 4 through 12
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments
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.
Time frame: Baseline, week 4, week 8 and week 12
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments
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.
Time frame: Baseline, week 4, week 8 and week 12
End of Treatment Satisfaction Survey Score
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.
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Time frame: 2 weeks