Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced Insomnia Coach, Sleep hygiene comparator.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder, Insomnia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Mobile App to Address Co-Occurring Sleep Problems and Heavy Alcohol Use Among Veterans Outside of Care Settings
Overview
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.
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 en - 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.
Primary outcome measures
- Insomnia symptoms [Time frame: Past 30 days]
- Alcohol use frequency [Time frame: Past 30 days]
- Alcohol use quantity [Time frame: Past 30 days]
Secondary outcome measures (2)
- Sleep quality [Time frame: Past 30 days]
- Alcohol-related consequences [Time frame: Past 30 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06487793 · R34AA030868