A PPG Sensor-Based Feedback Intervention for Heavy Drinking Young Adults

Yale University

Status: Completed

Conditions: Harmful; Use, Alcohol; Heavy Drinking

Treatments: Behavioral: Behavioral Self-Management; Behavioral: Behavioral Self-Management and Feedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05090995

21-002981 (Other Grant/Funding Number)

1R21AA028886-01A1 (U.S. NIH Grant/Contract)

2000030417

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Self-Monitoring and Feedback

Active Comparator group

Description:

The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries.

Treatment:

Behavioral: Behavioral Self-Management and Feedback

Self-Monitoring

Placebo Comparator group

Description:

The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time.

Treatment:

Behavioral: Behavioral Self-Management