Mindfulness-Based Intervention for Mild Traumatic Brain Injury — MBI-4-mTBI  

Concussion, Mild Clinical Trial

Official title: Mindfulness-Based Intervention for Mild Traumatic Brain Injury

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

One in three youth with a concussion will be afflicted with persistent post-concussive symptoms (PPCS), defined as the persistence of symptoms beyond one month of injury. PPCS may impair daily activities including schoolwork, socializing, and sports, thus reducing the quality of life. Preventive psychological interventions that foster coping skills may be key to managing concussions and reducing the risk of PPCS. Mindfulness-Based Interventions (MBI) are "present-centered" interventions, encouraging acceptance of thoughts and emotions as they occur in the moment, without judgment. The goal of the present pilot and feasibility randomized clinical trial (RCT) is to investigate whether the introduction of early targeted MBI training, delivered via a mobile application, can increase the quality of life and lead to improved adaptation to acute impairments of concussion. Further, we will establish the feasibility of conducting a larger RCT by investigating the ease of recruitment, credibility score, adherence to treatment, and retention of an app-based MBI. Participants with an acute concussion will be randomly assigned to one of two groups: (1) experimental group (n=63): early introduction of the MBI training; (2) control group (n=63): sham cognitive task and usual care. The targeted MBI training consists of a 4-week custom-made program for youth. Each standardized psychoeducation of meditation practice will be unlocked as the participant progresses through the program. The curriculum is based on previous validated MBI app protocols and team expertise in MBI. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Mild

• NCT number: NCT05105802
• Study type: Interventional
• Source: Children's Hospital of Eastern Ontario
• Contact: Andrée-Anne Ledoux, PhD
• Phone: 613-737-7600
• Email: aledoux@cheo.on.ca
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2022
• Completion date: December 30, 2023