Actively Recruiting
CoMBat Insomnia: Comparing Cognitive-Behavioral Therapy and Mindfulness-Based Treatment for Insomnia and Post-Traumatic Stress Symptoms in Adults with Traumatic Brain Injury
Led by Johns Hopkins University · Updated on 2026-05-28
360
Participants Needed
5
Research Sites
N/A
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
Researchers are comparing the effects of two types of telemedicine-delivered treatments to help adults with mild to moderate traumatic brain injury (TBI) who also have insomnia and post-traumatic stress symptoms. The study aims to see how cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) improve sleep and reduce depressive symptoms. This is a randomized controlled trial involving 360 participants. Participants will be randomly assigned to one of two treatment groups. The CBT-I group will receive a standardized six-session program focusing on education about sleep, stimulus control, sleep restriction, sleep hygiene, relaxation training, and cognitive restructuring. The MBTI group will also receive six sessions, combining mindfulness meditation with behavioral strategies like sleep restriction and stimulus control. Both interventions are delivered via telemedicine, and participants will wear wrist actigraph monitors and complete electronic sleep diaries throughout the study. Participants will be assessed with questionnaires, neurocognitive tests, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring at the start, end of treatment, and at 2, 6, and 12 weeks after treatment. The main measure is the change in insomnia severity using the Insomnia Severity Index. Secondary measures include pre-sleep arousal and depressive symptoms. The study also monitors adherence and cognitive functioning over time, with a follow-up period extending up to 24 weeks post-randomization.
CONDITIONS
Brief 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 uniformed services
- Meet the Veterans Affairs Medical Center and Department of Defense criteria for traumatic brain injury (TBI)
- Time since TBI injury is more than 90 days
- Insomnia symptoms lasting more than 90 days
- Insomnia Severity Index (ISI) score greater than 10
- Cognitive ability sufficient to provide informed consent (Montreal Cognitive Assessment Z-score above -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 and not caused by TBI
- Sleep apnea with apnea hypopnea index (AHI) over 15 (mild cases with AHI between 5 and 15 may participate but will be informed)
- Use of CPAP device allowed if AHI is below cutoff while using device, adherence is over 4 hours per night for 21 out of 30 days, and agreement to continue use during study
- Unstable psychotropic medication dosages (stable doses for at least the last three weeks are allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility
Duration - 6 weeks
Participants undergo a 6-week telemedicine-delivered behavioral treatment program, receiving either cognitive behavioral therapy for insomnia (CBT-I) or mindfulness-based treatment for insomnia (MBTI). Sessions include education, behavioral strategies, mindfulness exercises, and progress monitoring.
6 weekly telemedicine sessions
Duration - 12 weeks post-treatment
Participants complete assessments including psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring to evaluate insomnia severity and other outcomes after treatment ends.
3 assessment visits at 2, 6, and 12 weeks post-treatment
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
E
Elizabeth Wysocki, MS
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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