CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
NCT05663034
This study is recruiting at 5 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Traumatic Brain Injury
- Insomnia
- Depression
- Post-traumatic Stress
- Sleep
- Memory Impairment
- Cognitive Behavioral Therapy
- Concussion, Brain
- Head Injury
- Brain Injury Traumatic Mild
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Johns Hopkins University
- Last updated on ClinicalTrials.gov
- July 13, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Florida · 2
- Intrepid Spirit Center - Eglin Air Force Base · Eglin Air Force Base, FL
- Naval School Explosive Ordance Disposal - Eglin Air Force Base · Eglin Air Force Base, FL
Maryland · 1
- Walter Reed National Medical Military Center · Bethesda, MD
North Carolina · 1
- Womack Army Medical Center · Fort Bragg, NC
Washington · 1
- Madigan Army Medical Center · Fort Lewis, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.