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

NCT06108115 | Completed DMC

• 1 other identifier: 0799011810000
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  The Insomnia Severity Index are self-reported perceptions of sleep

  Change from Baseline at 3, 6,10 and 14 weeks

Secondary Outcomes (1)

• Relapse to Heavy Drinking

  Daily over the course of 14 weeks

Study Arms (2)

Behavioral: CueToSleep (Full Intervention Package)

EXPERIMENTAL

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.

Behavioral: CueToSleep (Full Intervention Package)

Measure (Behavioral Sensing Only)

NO INTERVENTION

Individuals will only be monitored using the passive sensing capabilities of the Full Intervention Package on their smartphones. These participants will not receive psychoeducational learning screens or behavior change suggestions.

Interventions

CueToSleep (Full Intervention Package) BEHAVIORAL

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.

Behavioral: CueToSleep (Full Intervention Package)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and older
• Meets criteria for lifetime alcohol use disorder (AUD), as defined by DSM-5
• Score \>/= 4 on AUDIT-C
• Reports difficulties with sleep and scores \>/= 10 on the Insomnia Severity Index
• Has been in recovery (abstinent) for \>/= 2 weeks, but less than 6 months
• Ability and willingness to provide informed consent
• Ability to understand and comprehend consent and protocol documents in English.
• Uses a smartphone compatible with the app.

You may not qualify if:

• Psychotic mental disorder other than bipolar disorder
• Current diagnosis of OCD, anorexia/ bulimia eating disorder, or antisocial personality disorder
• Acute suicidal ideation with plan or intent
• Meet DSM-5 criteria for current moderate to severe substance use disorder (SUD)
• Unable to comply with study procedures or protocols

Sponsors & Collaborators

• HealthRhythms, Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Alcoholism; Sleep Wake Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ellen Frank, PhD

  Health Rhythms

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 30, 2023
• Study Start: October 6, 2021
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)