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CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Recruiting

CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

1. Current or former member of the uniform services
2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;
3. Time duration since traumatic brain injury (TBI) injury \>90 days
4. Insomnia symptom duration \>90 days
5. Endorse insomnia symptoms (Insomnia Severity Index \[ISI\] score \> 10)
6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \> -2)
7. \>18 years of age
8. Access to and ability and to use computer.

Exclusion Criteria:

1. History of neurological diseases other than TBI and not attributable to TBI
2. Sleep apnea \[apnea hypopnea index (AHI) \>15; individuals with mild apnea (AHI \> 5 and \<15) will be informed, but allowed to participate\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea/hypopnea cutoff while using CPAP, are adherent to using the device (\> 4 hours/night 21/30 consecutive days) and agree to continue using the device during study participation.
3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

About the study

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).

What is being tested

Mindfulness-based treatment for insomnia (MBTI) (behavioral)
Cognitive behavioral therapy for insomnia (CBT-I) (behavioral)

Sponsor: Johns Hopkins University · Participants: 360 · Started: May 10, 2024

Contact the study team

Luis Buenaver, PHD · Phone: 4105507986

Official record on ClinicalTrials.gov — NCT05663034

Locations in the U.S.

Florida	Intrepid Spirit Center - Eglin Air Force Base, Eglin Air Force Base Naval School Explosive Ordance Disposal - Eglin Air Force Base, Eglin Air Force Base
Maryland	Walter Reed National Medical Military Center, Bethesda
North Carolina	Womack Army Medical Center, Fort Bragg
Washington	Madigan Army Medical Center, Fort Lewis

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.