Status:
COMPLETED
Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder
Lead Sponsor:
HealthRhythms, Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Abuse With Alcohol-Induced Sleep Disorder
Alcohol Use Disorder (AUD)
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
We will conduct a 14-week randomized controlled trial (RCT) of CueToSleep (behavioral monitoring via smartphone sensors and phone-based Cognitive Behavior Therapy for Insomnia) versus Measure (smartph...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT06108115
Start Date
October 6 2021
End Date
August 23 2023
Last Update
July 1 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112