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CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Sponsor: Johns Hopkins University
Summary
This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).
Official title: CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2024-05-10
Completion Date
2026-09
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Mindfulness-based treatment for insomnia (MBTI)
A 6-week intervention that uses the principles and practices of mindfulness meditation along with behavioral strategies (stimulus control, sleep restriction therapy) to reduce symptoms of insomnia
Cognitive behavioral therapy for insomnia (CBT-I)
Standard of care for adults with chronic insomnia. 6-week program that uses behavioral techniques to decrease psychophysiological arousal and increase sleep propensity to deepen and consolidate sleep.
Locations (5)
Intrepid Spirit Center - Eglin Air Force Base
Eglin Air Force Base, Florida, United States
Naval School Explosive Ordance Disposal - Eglin Air Force Base
Eglin Air Force Base, Florida, United States
Walter Reed National Medical Military Center
Bethesda, Maryland, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Madigan Army Medical Center
Fort Lewis, Washington, United States