Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans

Not Applicable

Not yet recruiting

• Conditions: Alcohol Use Disorder; Insomnia
• Interventions: Behavioral: Enhanced Insomnia Coach; Behavioral: Sleep hygiene comparator

• Registration Number: NCT06487793
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Study Start: 2024-09-01
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Insomnia Coach Mobile App Intervention	Enhanced Insomnia Coach	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.
Sleep Hygiene Control	Sleep hygiene comparator	Participants assigned to the control condition are asked to view sleep hygiene modules delivered by email once per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Alcohol use quantity	Past 30 days	Number of drinks per drinking occasion
Insomnia symptoms	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	Past 30 days	Days used in past 30 days

Secondary Outcome Measures

Name	Time	Method
Sleep quality	Past 30 days	The 19-item Pittsburgh Sleep Quality Index will assess nuanced sleep behaviors at each time point (e.g., sleep latency, sleep duration, subjective sleep quality)
Alcohol-related consequences	Past 30 days	15-item Short Inventory of Alcohol Problems assesses problems from alcohol use across multiple domains such as interpersonal, intrapersonal, and physical.