Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans

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

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 Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Enhanced Insomnia Coach; Behavioral: Sleep hygiene comparator

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Pedersen; Phone Number: (323) 442-4046; Email: Eric.Pedersen@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Enhanced Insomnia Coach; The intervention combines the Insomnia Coach app with additional brief alcohol intervention to facilitate behavior change for both drinking behavior and insomnia symptoms. Insomnia Coach contains multiple components of CBT-I (e.g., stimulus control, cognitive restructuring, relaxation training, sleep hygiene/psychoeducation, monitoring of sleep via journals). The brief alcohol intervention content added to the CBT-I app is based on CBT skills for moderate drinking, delivered in a motivational enhancement style, and has demonstrated efficacy among young adults and veterans (e.g., correcting perceived norms, use of protective behavioral strategies, challenging expectancies).
Active Comparator: 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.	Behavioral: Sleep hygiene comparator; Content is based on sleep hygiene practices, but without additional CBT-I content featured in the experimental condition. There is also not brief alcohol intervention content in the control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia symptoms	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.	Past 30 days
Alcohol use frequency	Days used in past 30 days	Past 30 days
Alcohol use quantity	Number of drinks per drinking occasion	Past 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	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)	Past 30 days
Alcohol-related consequences	15-item Short Inventory of Alcohol Problems assesses problems from alcohol use across multiple domains such as interpersonal, intrapersonal, and physical.	Past 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment initiation	Affirmative responses regarding whether participants initiated more formal treatment since starting the study	Past 30 days

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: University of Missouri-Columbia; RAND; Palo Alto Veterans Institute for Research

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Sleep Wake Disorders; Alcohol Drinking; Alcoholism; Dyssomnias; Parasomnias
• Other Study ID Numbers: R34AA030868 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared in accordance with NIH guidelines and uploaded to the NDA repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No