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Clinical Trials/NCT06487793
NCT06487793
Not Yet Recruiting
N/A

A Mobile App to Address Co-Occurring Sleep Problems and Heavy Alcohol Use Among Veterans Outside of Care Settings

University of Southern California0 sites130 target enrollmentSeptember 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
University of Southern California
Enrollment
130
Primary Endpoint
Alcohol use quantity
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to test the preliminary efficacy of a brief mobile app targeting insomnia symptoms among veterans. In this study, we will enhance the mobile app, Insomnia Coach, with content from brief alcohol interventions to help veterans reduce both insomnia symptoms and alcohol use behaviors. We will compare those veterans who are randomly assigned to receive this brief mobile app intervention to those who receive a control condition. This will help us determine if veterans randomly assigned to receive the intervention experience greater improvement on outcomes compared to those who do not receive the intervention. The study involves a beta-test phase of the app to ensure feasibility and acceptability by veterans, followed by a randomized controlled trial with 130 veterans who meet criteria for insomnia and alcohol use disorder.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
August 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Pedersen

Associate Professor

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • U.S. veteran aged 18 or older separated or discharged from service in the Air Force, Army, Marine Corps, Navy, or Coast Guard
  • Not currently affiliated with active duty service or on active reserves or guard service
  • Served since September 11, 2001
  • No past 6-month treatment for alcohol or drug use or insomnia
  • Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
  • Insomnia Severity Index (ISI) score of 10 or higher

Exclusion Criteria

  • Positive screening for other substance use disorders (not including cannabis use disorder)

Outcomes

Primary Outcomes

Alcohol use quantity

Time Frame: Past 30 days

Number of drinks per drinking occasion

Insomnia symptoms

Time Frame: Past 30 days

7-item Insomnia Severity Index (ISI). The ISI is a measure of insomnia symptoms including difficulty falling/staying asleep, sleep problems interfering with daily life, and concern about sleep problems.

Alcohol use frequency

Time Frame: Past 30 days

Days used in past 30 days

Secondary Outcomes

  • Sleep quality(Past 30 days)
  • Alcohol-related consequences(Past 30 days)

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