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Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder

NCT06108115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2024-07-01

No results posted yet for this study

Summary

In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score \>4) and are experiencing sleep problems (ISI score \>/= 10). 64 of these individuals will be randomly allocated to receive the full HealthRhythms package (sensing, trending, and stabilization) on their smartphones, while 64 will be asked to consent to sensing only. The duration of the study will be 14 weeks.

The primary outcome measures of the RCT will be the ISI (Insomnia Severity Index). The investigators hypothesize that those receiving the full package will demonstrate lower levels of sleep disturbance.

Conditions

  • Alcohol Abuse With Alcohol-Induced Sleep Disorder
  • Alcohol Use Disorder (AUD)
  • Sleep Disorder
  • Sleep Disturbance

Interventions

BEHAVIORAL

CueToSleep (Full Intervention Package)

Individuals will be randomly allocated to receive the full Health Rhythms package (CueToSleep) program on their smartphones. The package includes 24/7 behavioral sensing from the participant's smartphone using the global positioning system, accelerometer, and screen on/off state, as well as a series of psychoeducational learning screens about the relationship among alcohol, mood disturbance and sleep, and personalized suggestions for behavior change to improve sleep that will be sent to the participant every 3 to 4 days. These suggestions will be based on behaviors indicated by the individual participant's sensor data over the previous 3 to 4 days.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • HealthRhythms, Inc.

    lead INDUSTRY

Principal Investigators

  • Ellen Frank, PhD · Health Rhythms

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2023-08-23
Completion
2023-08-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06108115 on ClinicalTrials.gov