Clinical trial NCT05090995: A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults
Official title: A Photoplethysmography Sensor-based Personalized Feedback Intervention for Heavy-drinking Young Adults Targeting Heart Rate Variability, Resting Heart Rate, and Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking
Harmful; Use, Alcohol
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible subjects will be randomized into either the Assessment or Feedback group. Subjects in the assessment group will not receive personalized health feedback or advice on their health behaviors. They will wear a consumer- level PPG device daily and complete electronic diaries about bedtime behavior and sleep from the previous night for six weeks. Subjects in the feedback group will also wear a consumer-level PPG device and complete diaries each morning for six weeks. Subjects in this group will monitor their health behaviors and receive personalized feedback and advice. Subjects will also be able to receive daily information regarding their health behaviors from the PPG device application. At weeks two, four, and six subjects will will receive written reports that summarize their alcohol usage and the links made between their drinking and health outcomes from the PPG application results. Subjects will also receive advice on how to improve health behaviors.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Proposed is a study to conduct the first controlled test of a feedback intervention targeting heart rate variability, resting heart rate, and sleep for heavy-drinking young adults (N=60; ages 18-25) and will leverage the capabilities of a consumer-marketed PPG sensor/mobile app. This study will evaluate the feasibility, acceptability, and preliminary efficacy of this intervention for promoting improvements in drinking, sleep, and health.

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

Primary outcomes:
measure: Total Drinks Consumed
timeFrame: up to Week 10
Secondary outcomes:
measure: Drinks Per Drinking Day
timeFrame: up to 10 weeks
measure: Percent Heavy Drinking Days
timeFrame: up to 10 weeks
measure: Percent Abstinent Days
timeFrame: up to 10 weeks
measure: Alcohol-related Consequences
timeFrame: baseline, Week 6, and Week 10
measure: Sleep Quality
timeFrame: baseline and Week 10
measure: Sleep-related Impairment
timeFrame: baseline and Week 10
measure: Sleep Duration
timeFrame: up to 6 weeks
measure: Heart Rate Variability (HRV)
timeFrame: up to 6 weeks
measure: Lowest Resting Heart Rate (RHR)
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
name: Lisa Fucito, PhD
role: PRINCIPAL_INVESTIGATOR
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