Smartphone App-Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for...

Area of Science:

• Neuroscience
• Psychology
• Digital Therapeutics

Background:

• Concussion affects 30-35% of pediatric patients with prolonged symptoms impacting quality of life.
• Early psychological intervention may improve emotional regulation and adaptation to post-injury symptoms.

Purpose of the Study:

• Assess feasibility of a randomized controlled trial (RCT) for a digital therapeutics (DTx) mindfulness-based intervention (MBI) in adolescents (12-<18 years).
• Examine intervention effects on quality of life, resilience, cognition, and symptom burden.
• Investigate neurophysiological changes using brain imaging.

Main Methods:

• Double-blind, Health Canada-regulated trial with 70 participants enrolled within 7 days of concussion.
• Random assignment to a 4-week DTx MBI or attention-matched comparator.
• Feasibility assessed by recruitment, adherence, and retention; outcomes measured at 1, 2, and 4 weeks post-injury.
• Magnetic resonance imaging in 60 participants to identify neurophysiological mechanisms.

Main Results:

• Recruitment began October 2022; data collection ongoing until September 2024.
• Data analysis is pending completion of data collection and management.

Conclusions:

• Trial will confirm feasibility and inform a definitive efficacy RCT.
• A smartphone-based MBI could be an accessible, low-risk preventive treatment for youth at risk of prolonged postconcussion symptoms.