Mindfulness-Based Intervention for Mild Traumatic Brain Injury

Summary

Mindfulness is a promising tool which may foster adaptative interpersonal qualities to reduce the risk of persistent post-concussion symptoms. The present feasibility study will customize and validate a mindfulness mobile smart-phone app easily accessible to youth and families. The study will also determine whether mindfulness training increases quality of life, reduces symptom burden and promotes neurophysiological recovery at 4 weeks post-injury in adolescents who were diagnosed with an acute concussion compared to a cognitive sham app + usual care.

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.

Sponsors & Collaborators

• Mobio Interactive PTE LTD

  collaborator INDUSTRY

• University of Ottawa

  collaborator OTHER

• Academic Health Science Centres

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  lead OTHER

Principal Investigators

• Andrée-Anne Ledoux, PhD · Children's Hospital of Eastern Ontario Research Institute

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-04

Primary Completion

2024-07-06

Completion

2024-07-06

Countries

• Canada

Study Locations