Actively Recruiting
CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Led by Johns Hopkins University · Updated on 2025-12-18
360
Participants Needed
5
Research Sites
120 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current or former member of the uniform services
- Meet Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for traumatic brain injury (TBI)
- More than 90 days since traumatic brain injury (TBI) injury
- Insomnia symptoms lasting more than 90 days
- Insomnia Severity Index (ISI) score greater than 10
- Sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score greater than -2)
- Age over 18 years
- Access to and ability to use a computer
You will not qualify if you...
- History of neurological diseases other than TBI not caused by TBI
- Sleep apnea with apnea hypopnea index (AHI) over 15 (mild apnea with AHI between 5 and 15 allowed with notification)
- Participants using a continuous positive airway pressure (CPAP) device must have AHI below cutoff while using CPAP, use the device at least 4 hours per night for 21 of 30 consecutive days, and agree to continue its use during the study
- Unstable dosage of psychotropic medications (stable dosage for at least 3 weeks prior to study is allowed)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Intrepid Spirit Center - Eglin Air Force Base
Eglin Air Force Base, Florida, United States, 32542
Actively Recruiting
2
Naval School Explosive Ordance Disposal - Eglin Air Force Base
Eglin Air Force Base, Florida, United States, 32542
Actively Recruiting
3
Walter Reed National Medical Military Center
Bethesda, Maryland, United States, 20814
Actively Recruiting
4
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Actively Recruiting
5
Madigan Army Medical Center
Fort Lewis, Washington, United States, 98431
Actively Recruiting
Research Team
L
Luis Buenaver, PHD
CONTACT
E
Elizabeth Wysocki, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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