Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans

NCT06487793 | Not Yet Recruiting DMC

• 1 other identifier: R34AA030868
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcohol Use Disorder; Insomnia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Sleep quality

  Past 30 days

• Alcohol-related consequences

  Past 30 days

Other Outcomes (1)

• Treatment initiation

  Past 30 days

Study Arms (2)

Enhanced Insomnia Coach Mobile App Intervention

EXPERIMENTAL

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

Sleep Hygiene Control

ACTIVE COMPARATOR

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

Interventions

Enhanced Insomnia Coach BEHAVIORAL

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).

Enhanced Insomnia Coach Mobile App Intervention

Sleep hygiene comparator BEHAVIORAL

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.

Sleep Hygiene Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• RAND: collaborator
• Palo Alto Veterans Institute for Research: collaborator
• University of Missouri-Columbia: collaborator

MeSH Terms

Conditions

Alcoholism; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Eric Pedersen

CONTACT

(323) 442-4046; Eric.Pedersen@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 5, 2024

Record last verified: 2024-06