NCT07272941

Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Children's Hospital of Eastern Ontario · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study has two groups: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) control group: usual care plus early introduction sham application, including the cognitive math game called 2048. Usual care in both groups refers to the recommended return to physical and cognitive activity 24-48 hours post-injury. To maintain valid results, participants will be "blinded" to their intervention. (i.e., during the informed consent process, the study will be referred to as the App-based Intervention study with the purpose of evaluating two app-based interventions). Although only one group will receive the MBI intervention, both groups will be receiving usual care instructions, which involves the early return to cognitive and physical activities. Therefore, both groups will be receiving a beneficial intervention with the experimental group receiving the additional MBI that is being assessed. For both groups, Treatment Coaches will be assigned to each participant. Coaches will maintain regular communication with patients. Their role will be to encourage and assist participants throughout the study duration through a standardized question-and-answer protocol. Additionally, to increase adherence to the intervention, participants will complete a motivational interview at 2 weeks. After 4 weeks, all participants will be offered the MBI program for an extra period of 4 weeks. The control group will have the possibility at that time to crossover and start the intervention if desired.

Conditions

• Concussions
• Mild Traumatic Brain Injury, Concussion
• Concussion Mild

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Based Intervention (MBI)	Using the Dawn MBI-based app, targeted MBI training will consist of a 4-to-8-week custom-made program that includes audio-recorded lectures, guided meditations such as walking meditations and body scans, setting intentions and check-in with mood, and writing events journal. Each standardized course is unlocked as the participant progresses through the MBI program. Participants will be encouraged to engage in the app-based activities for at least 10 minutes every day, with a minimum of 4 days per week, over a period of 4 weeks (with option to continue for 8 weeks).
BEHAVIORAL	Cognitive Sham	Usual care recommends that the patient refrain from physical and cognitive activities for 24-48 hours after injury. After the rest period, it is recommended that low to moderate levels of physical and cognitive activity be gradually started 24-48 hours after injury. The activities should be performed at a level that does not result in recurrence or exacerbation of symptoms. Children must refrain from any activities that increase the risk of re-injury (drills with body contact or that risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. The sham journey will consist of playing an open-source cognitive math game (called "2048") delivered through the same app as MBI, but without the mindfulness content. Participants will be encouraged to utilize the app for at least 10 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-05-01
• Completion: 2029-12-01
• First posted: 2025-12-09
• Last updated: 2026-03-18

Locations

5 sites across 1 country: Canada