Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans

University of Southern California

Status: Not yet enrolling

Conditions: Insomnia; Alcohol Use Disorder

Treatments: Behavioral: Enhanced Insomnia Coach; Behavioral: Sleep hygiene comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06487793

R34AA030868 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Enhanced Insomnia Coach Mobile App Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced Insomnia Coach

Sleep Hygiene Control

Active Comparator group

Description:

Participants assigned to the control condition are asked to view sleep hygiene modules delivered by email once per week for 8 weeks.

Treatment:

Behavioral: Sleep hygiene comparator