Clinical Trial

Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

Study acronym: MBI-4-mTBI
Not Yet Recruiting
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Summary
Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-08.
Trial Details
NCT Number NCT07272941
Lead Sponsor Children's Hospital of Eastern Ontario
Collaborators: The Hospital for Sick Children, Montreal Children's Hospital of the MUHC, University of Ottawa, British Columbia Children's Hospital, Stollery Children's Hospital
Conditions Concussions, Mild Traumatic Brain Injury, Concussion, Concussion Mild
Enrollment 362 participants
Start Date 2026-05
Primary Completion 2029-05 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-18