Mindfulness-Based Intervention for Mild Traumatic Brain Injury

NACompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

October 4, 2022

Primary Completion Date

July 6, 2024

Study Completion Date

July 6, 2024

Conditions
Concussion, Mild
Interventions
BEHAVIORAL

Mindfulness-Based Intervention

Using AmDtx MBI-based app, targeted MBI training will consist of a 4-week custom-made program that include, setting intentions and check-in with mood, audio-recorded lectures, guided meditations such as body scans, and writing events journal (Appendix 5). Each standardized course will be unlocked as the child progresses through the program. Users will be encouraged to participate in the app-based activities for a total of 10-15 minutes every day, with a minimum of 4 days in a week, over a period of 4 weeks.

BEHAVIORAL

Cognitive Sham + Usual Care

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 delivered through the same app as MBI, but without the mindfulness content.

Trial Locations (1)

Unknown

Children's Hospital of Eastern Ontario, Ottawa

Sponsors
All Listed Sponsors
collaborator

Mobio Interactive PTE LTD

INDUSTRY

collaborator

University of Ottawa

OTHER

collaborator

Academic Health Science Centres

OTHER

lead

Children's Hospital of Eastern Ontario

OTHER

NCT05105802 - Mindfulness-Based Intervention for Mild Traumatic Brain Injury | Biotech Hunter | Biotech Hunter