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NCT Number: NCT06487793

Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

  2. Alcohol use frequency

    Time frame: Past 30 days

    Days used in past 30 days

  3. Alcohol use quantity

    Time frame: Past 30 days

    Number of drinks per drinking occasion

Secondary outcomes

  1. Sleep quality

    Time frame: 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)

  2. Alcohol-related consequences

    Time frame: Past 30 days

    15-item Short Inventory of Alcohol Problems assesses problems from alcohol use across multiple domains such as interpersonal, intrapersonal, and physical.

Other outcomes

  1. Treatment initiation

    Time frame: Past 30 days

    Affirmative responses regarding whether participants initiated more formal treatment since starting the study

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Pedersen

CONTACT

[email protected]

(323) 442-4046

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Palo Alto Veterans Institute for Research
  • RAND
  • University of Missouri-Columbia

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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