Mindfulness-Based Intervention for Mild Traumatic Brain Injury

Children's Hospital of Eastern Ontario99 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

Conditions

Concussion, Mild

Interventions

Mindfulness-Based InterventionBEHAVIORAL

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.

Cognitive Sham + Usual CareBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Eastern Ontario

Ottawa, Canada

Outcomes

Primary Outcomes

Ease of Recruitment

Descriptive variable. Ease of recruitment will be defined as having at least 60% approached and eligible participants agreeing to participate. A higher score means easier recruitment.

Time frame: 48 hours post-injury

Credibility Score (Credibility and Expectancy Questionnaire)

The Credibility and Expectancy Questionnaire is a 6-item The credibility score is derived from the items 1-3 and the expectancy scores is derived from the items 4-6. A higher score means better credibility. The treatment will be considered as credible if 80% of the participants rated the treatment as credible.

Time frame: 1 week post-injury

Retention

Descriptive variable. Adequate retention will be defined as having 70% of participants completing at least 60% of the 4-week intervention and the outcome measurement post-treatment. A higher score means better retention.

Time frame: 4 weeks post-injury

Adherence to Treatment

Calculated based on the time spent on the app. A higher score means better adherence.

Time frame: 4 weeks post-injury

Secondary Outcomes

Pediatric Quality of Life Inventory™ version 4.0

The Pediatric Quality of Life Inventory™ version 4.0 is a reliable and valid measure of quality of life in healthy children and adolescents and those with acute and/or chronic health conditions.The inventory covers four domains: physical, emotional, social, and school. It is a 23-item, 5-point Likert scale producing a total score (range=0-92) and 4 domain scores (physical, emotional, social, and school). Higher scores indicate better outcomes.

Time frame: 4 weeks post-injury

Health and Behaviour Inventory

Data from ClinicalTrials.gov

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