Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)
Concussion, Mild
About this trial
This is an interventional prevention trial for Concussion, Mild focused on measuring mild traumatic brain injury, intervention, treatment, persistent post-concussive symptoms, quality of life, meditation
Eligibility Criteria
Inclusion Criteria:
- Subjects presenting to CHEO's Emergency Department (ED) within 48 hours of sustaining a direct or indirect head injury
- Aged 12 through 17.99 years
- Have a concussion, as defined by the Berlin consensus statement
- Score >4 on the predicting persistent postconcussive problems in pediatric (5P) clinical rule
- Proficient in English.
Exclusion Criteria:
- Glasgow Coma Scale ≤13
- Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required but may be performed if clinically indicated)
- Neurosurgical operative intervention, intubation, or intensive care required
- Multi-system injuries with treatment requiring hospital admission, operating room, or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria)
- Severe chronic neurological developmental delay resulting in communication difficulties
- Intoxication at the time of ED presentation as per clinician judgment
- History of trauma as primary events (e.g., seizure, syncope, migraine)
- Prior psychiatric hospitalization
- Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression is not exclusionary)
- Inability to obtain a proper written informed consent/assent (e.g., language barrier, absence of parental authority, developmental delay, intoxication, patients too confused to consent)
- Legal guardian not present (certain forms need to be completed by parents/legal guardians)
- No Internet or mobile/tablet access.
Sites / Locations
- Children's Hospital of Eastern OntarioRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Mindfulness Intervention
Cognitive Sham Application + Usual Care
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. 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.
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. We consider this arm as active as participants will be assigned to a cognitive sham app (cognitive math game) delivered via the same app (same main interface as the mindfulness intervention). However, they will not take part in the MBI program for the first 4 weeks. On a daily basis, participants will be asked questions about their stress and emotions and about their symptoms.