NCT05663034 · RECRUITING
CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
This trial compares two talk-based therapies for insomnia in military veterans and service members with a past traumatic brain injury and trauma-related stress symptoms. Both are delivered by video over six sessions. The main measure is sleep quality on the Insomnia Severity Index. It is not a drug trial, and the phase is not applicable, meaning it is a behavioral study.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-13