NCT05663034 CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
| NCT ID | NCT05663034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2024-05-10 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Luis Buenaver, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT05663034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05663034 currently recruiting?
Yes, NCT05663034 is actively recruiting participants. Contact the research team at lbuenav1@jhmi.edu for enrollment information.
Where is the NCT05663034 trial being conducted?
This trial is being conducted at Eglin Air Force Base, United States, Eglin Air Force Base, United States, Bethesda, United States, Fort Bragg, United States and 1 additional location.
Who is sponsoring the NCT05663034 clinical trial?
NCT05663034 is sponsored by Johns Hopkins University. The principal investigator is Luis Buenaver, PhD at Johns Hopkins School of Medicine. The trial plans to enroll 360 participants.