CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms (NCT05663034)
CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Intrepid Spirit Center - Eglin Air Force Base — Eglin Air Force Base, Florida
Age range: 18 Years
🧪 Interventions in This Study
- Mindfulness-based treatment for insomnia (MBTI) (BEHAVIORAL)
- Cognitive behavioral therapy for insomnia (CBT-I) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Intrepid Spirit Center - Eglin Air Force Base — Eglin Air Force Base, Florida
- Naval School Explosive Ordance Disposal - Eglin Air Force Base — Eglin Air Force Base, Florida
- Walter Reed National Medical Military Center — Bethesda, Maryland
- Womack Army Medical Center — Fort Bragg, North Carolina
- Madigan Army Medical Center — Fort Lewis, Washington
📞 Contact the Study Coordinator
Phone: (410) 550-7986
Email: lbuenav1@jhmi.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Traumatic Brain Injury
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- Improving Time-Based Prospective Memory in TBI — East Hanover, New Jersey
- Re-entry Continuum for Brain Injury — Greencastle, Indiana
- Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury — Minneapolis, Minnesota
- TRACK-TBI Longitudinal Biomarker Study — San Francisco, California
- Narrative Discourse Treatment Development — West Haven, Connecticut
Explore by condition: All Traumatic Brain Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.