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

Recruiting now · Not applicable

Conditions studied: Traumatic Brain Injury, Insomnia, Depression, Post-traumatic Stress, Sleep, Memory Impairment, Cognitive Behavioral Therapy, Concussion, Brain, Head Injury, Brain Injury Traumatic Mild

In brief

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).

Key facts

Study ID: NCT05663034
Run by: Johns Hopkins University
People needed: 360
Starts: 2024-05-10
Expected to finish: 2027-06-01
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

History of neurological diseases other than TBI and not attributable to TBI
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.
Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.