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

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
NCT05663034 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

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

5 sites
Intrepid Spirit Center - Eglin Air Force Base
Eglin Air Force Base, United States
Naval School Explosive Ordance Disposal - Eglin Air Force Base
Eglin Air Force Base, United States
Walter Reed National Medical Military Center
Bethesda, United States
Womack Army Medical Center
Fort Bragg, United States
Madigan Army Medical Center
Fort Lewis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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