NCT07335276

Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI)

Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI): A Pilot Randomized Controlled Trial for Service Members

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Madigan Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot clinical trial is to evaluate the effectiveness and delivery method of a CBTI self-managed digital mobile application in service members. The main questions it aims to answer are: RQ1. Will the delivery of CBTI via a self-managed mobile application over five weeks improve sleep outcomes for service members? RQ2. Will the delivery of CBTI via a self-managed mobile application over five weeks improve secondary outcomes (sleep-related impairment, depression, PTSD symptoms, and quality of life) for service members?

Detailed description

Participants enrolled in this trial will: * Week 1: Complete a series of questionnaires (approximately 15 minutes) \& complete a daily sleep diary for one week (three minutes each morning). * Weeks 2-6: Participate in one of two groups that are randomly assigned: * Group 1: Starts use of the smart phone app with treatment for insomnia for five weeks. Each day during weeks 2-6 you will complete a daily sleep diary on the app and review individual sleep treatment recommendations (total of 5 minutes each morning). OR * Group 2: Will wait for five weeks * End of Week 6: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes), \& complete a daily sleep diary for one week (three minutes each morning). * Week 10: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes) about insomnia symptoms, any sleep related impaired function, depression symptoms, post-traumatic stress disorder symptoms, and quality of life. Participants randomized to the wait list will be contacted to provide information and support on how to use the smart phone app for treatment with insomnia.

Conditions

• Insomnia
• Depression - Major Depressive Disorder
• PTSD

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	This intervention will be delivered via a smart phone app

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-10-02
• Completion: 2028-10-02
• First posted: 2026-01-13
• Last updated: 2026-01-22