N/A
N=60
A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults
Heavy Drinking · Harmful; Use, Alcohol
Bottom Line
View on ClinicalTrials.gov: NCT05090995 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Total Drinks Consumed — 6.76; 7.07 drinks — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Self-Management and Feedback (Behavioral); Behavioral Self-Management (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Drinks Consumed |
6.76; 7.07 | <0.0001 sig |
| SECONDARY Drinks Per Drinking Day |
2.26; 2.34 | <0.0001 sig |
| SECONDARY Percent Heavy Drinking Days |
18.62; 19.83 | <0.0001 sig |
| SECONDARY Percent Abstinent Days |
66.04; 65.56 | <0.0001 sig |
| SECONDARY Alcohol-related Consequences |
8.56; 8.23 | <.0001 sig |
| SECONDARY Sleep Quality |
50.59; 50.38 | <.0001 sig |
| SECONDARY Sleep-related Impairment |
53.98; 55.05 | <.0001 sig |
| SECONDARY Sleep Duration |
168.73; 170.78; 172.18; 169.38; 171.74; 170.11 | 0.02 sig |
| SECONDARY Heart Rate Variability (HRV) |
7.55; 7.79; 7.63; 7.81; 7.68; 7.84 | 0.0001 sig |
| SECONDARY Lowest Resting Heart Rate (RHR) |
4.06; 4.03; 4.06; 4.03; 4.05; 4.03 | 0.04 sig |
Summary
Heavy alcohol use among young adults is a significant public health problem. Advances in technology may offer an innovative solution. This project will conduct the first controlled test of a feedback intervention for reducing drinking and improving health in young adults by targeting heart rate variability, resting heart rate, and sleep via biosensors and electronic diary methods.
Eligibility Criteria
Inclusion Criteria
- 18-25 years of age
- Report ≥ 4 heavy drinking occasions in the past 28 days
- Report Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) scores indictive of risk of drinking harm
- English Speaking
- Have a personal smartphone
Exclusion Criteria
- Sleep Disorder History
- Night/ Rotating work shift
- Travel two or more time zones in the month prior to the study or anticipated travel two or more times during study participation
- Clinically severe AUD in past 12 months
- Currently enrolled in alcohol or sleep treatment
- Current, severe psychiatric illness
- Current DSM-V substance use disorder
- Positive urine drug screen for a substance other than marijuana
Data sourced from ClinicalTrials.gov (NCT05090995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.