Clinical trial NCT05105802: Mindfulness-Based Intervention for Mild Traumatic Brain Injury
Official title: Mindfulness-Based Intervention for Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Keywords: mild traumatic brain injury
intervention
treatment
persistent post-concussive symptoms
quality of life
meditation
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Mobio Interactive PTE LTD
name: University of Ottawa
name: Academic Health Science Centres
First posted: 2021-11-03
Enrollment: 99
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Double-blind randomized clinical trial with 2 groups
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Ease of Recruitment
timeFrame: 48 hours post-injury
measure: Credibility Score (Credibility and Expectancy Questionnaire)
timeFrame: 1 week post-injury
measure: Retention
timeFrame: 4 weeks post-injury
measure: Adherence to Treatment
timeFrame: 4 weeks post-injury
Secondary outcomes:
measure: Pediatric Quality of Life Inventory™ version 4.0
timeFrame: 4 weeks post-injury
measure: Health and Behaviour Inventory
timeFrame: 2 and 4 weeks post-injury
measure: Post-Concussion Symptom Inventory (PCSI)
timeFrame: 2 and 4 weeks post-injury
measure: Self-Efficacy Questionnaire for Children
timeFrame: 4 weeks post-injury
measure: NIH Toolbox Cognitive Battery
timeFrame: 4 weeks post-injury
measure: The Connor-Davidson Resilience Scale-10
timeFrame: 4 weeks post-injury
measure: General Anxiety Disorder 7-items (GAD)
timeFrame: 4 weeks post-injury
measure: Center for Epidemiologic Studies Short Depression Scale
timeFrame: 4 weeks post-injury
measure: Child and Adolescent Mindfulness Measure
timeFrame: 4 weeks post-injury
measure: Functional Connectivity measured by Resting-State Functional MRI
timeFrame: 72 hours and 4th week post-injury
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario Research Institute
name: Andrée-Anne Ledoux, PhD
role: PRINCIPAL_INVESTIGATOR
References: