Drinking, Alcohol
Conditions
Keywords
Sleep Disorders, Self-Management, Telemedicine, Health Education, Wearable Electronic Devices
Brief summary
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.
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 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.
Interventions
BEHAVIORALSelf-monitoring
Participants will complete daily smartphone-based sleep and alcohol diaries for two weeks.
BEHAVIORALAdvice
Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep health advice.
BEHAVIORALFeedback
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
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Random assignment to one of three groups in 2:1:1 ratio, each group receiving some variation on 2-week intervention. Measurements taken at baseline, 4 weeks, 8 weeks, 12 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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 smartphone 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
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 severe psychiatric illness (i.e., bipolar disorder, schizophrenia, major depression, panic disorder, organic mood or mental disorders, or suicide or violence risk) by history or psychological examination; 6. current DSM-V substance use disorder (other than cannabis) or a positive urine drug screen for opiates, cocaine, barbiturates, benzodiazepines, amphetamines, or phencyclidine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stop-signal Reaction Time | 4 weeks | The difference between the mean reaction time and the stop-signal delay on the stop-signal test. Upon results entry, the following was added: This outcome will be explored as a potential mechanism of sleep intervention condition effects on the primary outcome of total drinks consumed. If there is a significant effect of condition on total drinks, the analysis of stop signal reaction time will be conducted. Due to COVID-19, this assessment was stopped since it could not be administered virtually. Since there was no effect of condition on total drinks consumed, an analysis of this outcome as a potential mechanism was not undertaken. The following represents the number of participants in each condition had this assessment conducted prior to COVID. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Advice Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice. | 30 |
| Advice + Self-monitoring Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks. | 30 |
| Advice + Self-monitoring + Feedback Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
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. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Total | Advice | Advice + Self-monitoring | Advice + Self-monitoring + Feedback |
|---|---|---|---|---|
| Age, Continuous | 21.2 years STANDARD_DEVIATION 1.8 | 20.9 years STANDARD_DEVIATION 1.7 | 21.3 years STANDARD_DEVIATION 1.8 | 21.2 years STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 5 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 25 Participants | 25 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 1 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 96 Participants | 26 Participants | 25 Participants | 45 Participants |
| Region of Enrollment United States | 120 participants | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 61 Participants | 15 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 59 Participants | 15 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 60 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 60 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 60 |
Outcome results
Primary
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
Population: Intention to treat analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Advice | Total Alcohol Drinks Consumed Over the 12wk Followup | 3.07 log-transformed total alcohol drinks | Standard Error 0.13 |
| Advice + Self-monitoring | Total Alcohol Drinks Consumed Over the 12wk Followup | 2.95 log-transformed total alcohol drinks | Standard Error 0.12 |
| Advice + Self-monitoring + Feedback | Total Alcohol Drinks Consumed Over the 12wk Followup | 2.96 log-transformed total alcohol drinks | Standard Error 0.09 |
Comparison: Testing for group effect.p-value: 0.75Mixed Models Analysis
Secondary
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.
Time frame: 2 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Advice | End of Treatment Satisfaction Survey Score | 3.45 score on a scale | Standard Error 0.74 |
| Advice + Self-monitoring | End of Treatment Satisfaction Survey Score | 3.48 score on a scale | Standard Error 0.57 |
| Advice + Self-monitoring + Feedback | End of Treatment Satisfaction Survey Score | 3.60 score on a scale | Standard Error 0.56 |
Secondary
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
Population: Intention to treat analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Advice | National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments | 51.39 T-score | Standard Error 0.67 |
| Advice + Self-monitoring | National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments | 49.75 T-score | Standard Error 0.65 |
| Advice + Self-monitoring + Feedback | National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments | 49.46 T-score | Standard Error 0.45 |
Comparison: Testing for group effect.p-value: 0.05Mixed Models Analysis
Secondary
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
Population: Intention to treat analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Advice | National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments | 57.80 T-score | Standard Error 0.9 |
| Advice + Self-monitoring | National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments | 57.05 T-score | Standard Error 0.88 |
| Advice + Self-monitoring + Feedback | National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments | 54.89 T-score | Standard Error 0.62 |
Comparison: Testing for group effect.p-value: 0.02Mixed Models Analysis
Other Pre-specified
Stop-signal Reaction Time
The difference between the mean reaction time and the stop-signal delay on the stop-signal test. Upon results entry, the following was added: This outcome will be explored as a potential mechanism of sleep intervention condition effects on the primary outcome of total drinks consumed. If there is a significant effect of condition on total drinks, the analysis of stop signal reaction time will be conducted. Due to COVID-19, this assessment was stopped since it could not be administered virtually. Since there was no effect of condition on total drinks consumed, an analysis of this outcome as a potential mechanism was not undertaken. The following represents the number of participants in each condition had this assessment conducted prior to COVID.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Advice | Stop-signal Reaction Time | 22 Participants |
| Advice + Self-monitoring | Stop-signal Reaction Time | 19 Participants |
| Advice + Self-monitoring + Feedback | Stop-signal Reaction Time | 43 Participants |