A Mobile App to Address Co-Occurring Sleep Problems and Heavy Alcohol Use Among Veterans Outside of Care Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 130
- Primary Endpoint
- Alcohol use quantity
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants are asked to complete one of two mobile phone-based programs. They may not know which condition is the experimental condition and which is the control.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Enhanced Insomnia Coach Mobile App Intervention
Participants assigned to the experimental condition are asked to view the modules within the app for 8 weeks. The mobile app contains content based on cognitive behavioral therapy for insomnia (CBT-I) enhanced with content from brief alcohol interventions.
Intervention: Enhanced Insomnia Coach (Behavioral)
Sleep Hygiene Control
Participants assigned to the control condition are asked to view sleep hygiene modules delivered by email once per week for 8 weeks.
Intervention: Sleep hygiene comparator (Behavioral)
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)
Investigators
Eric Pedersen
Associate Professor
University of Southern California