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

February 26, 2025 updated by: Andree-Anne Ledoux, Children's Hospital of Eastern Ontario
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Ottawa, Canada
        • Children'S Hospital Of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness Intervention
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.
Behavioral: Mindfulness-Based Intervention
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.
Other Names:
  • MBI, AmDtx
Active Comparator: Cognitive Sham Application + Usual Care
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.
Behavioral: Cognitive Sham + Usual Care
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.
Other Names:
  • Cognitive Sham, Usual Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ease of Recruitment
Time Frame: 48 hours post-injury
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.
48 hours post-injury
Credibility Score (Credibility and Expectancy Questionnaire)
Time Frame: 1 week post-injury
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.
1 week post-injury
Retention
Time Frame: 4 weeks post-injury
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.
4 weeks post-injury
Adherence to Treatment
Time Frame: 4 weeks post-injury
Calculated based on the time spent on the app. A higher score means better adherence.
4 weeks post-injury

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory™ version 4.0
Time Frame: 4 weeks post-injury
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.
4 weeks post-injury
Health and Behaviour Inventory
Time Frame: 2 and 4 weeks post-injury
The Health and Behaviour Inventory is validated symptom scale. It is a 20-item self-report questionnaire, 4-point Likert scale (total range 0-60) yielding scores for cognitive and somatic symptom scales. A higher score indicate worse outcome.
2 and 4 weeks post-injury
Post-Concussion Symptom Inventory (PCSI)
Time Frame: 2 and 4 weeks post-injury
The Post-Concussion Symptom Inventory (PCSI) is a validated, reliable, comprehensive, self-administered instrument for children and adolescents. For the purpose of this study, the emotional and sleep domain of the PCSI adolescent scale version (20-item, 7-point Likert scale) will be used. A higher score indicate worse outcome.
2 and 4 weeks post-injury
Self-Efficacy Questionnaire for Children
Time Frame: 4 weeks post-injury
The Self-Efficacy Questionnaire for Children is a valid and reliable assessment, Cronbach's α=0.88. It is a 24-item, 5-point Likert scale questionnaire producing a total score (0-120), and emotional, social, and academic sub-scores. A higher score indicate better outcome.
4 weeks post-injury
NIH Toolbox Cognitive Battery
Time Frame: 4 weeks post-injury
The NIH Toolbox Cognitive Battery, a validated and reliable computerized battery designed to measure fluid cognitive functioning (executive function, attention, episodic memory, language, processing speed, and working memory). Raw performance is transformed to age-corrected standard scores, for which the normative mean in 100 and the standard deviation is 15. Other types of scores computed by the battery include fully corrected t-scores (mean of 50 and standard deviation of 10, comparing the score of the participant to those of the normative sample while adjusting for key demographic variables: age, gender, race/ethnicity, educational attainment), uncorrected standard scores (normative mean of 100 and standard deviation of 100), percentiles. Higher scores indicate better outcomes.
4 weeks post-injury
The Connor-Davidson Resilience Scale-10
Time Frame: 4 weeks post-injury
The Connor-Davidson Resilience Scale-10 is a validated questionnaire in an adolescent concussed population. It is a 10-item, 5-point Likert scale assessing the individual's own perception of hardiness or perceived stress (total score range=0-40). A higher score indicates better outcome.
4 weeks post-injury
General Anxiety Disorder 7-items (GAD)
Time Frame: 4 weeks post-injury
The GAD-7 is a validated, reliable, and sensitive to treatment-related changes tool that assesses anxiety symptoms in youth. It is a 7-item, 3-point Likert scale questionnaire providing a sum score (0-21) of the level of general anxiety disorder. A higher score indicate worse outcome.
4 weeks post-injury
Center for Epidemiologic Studies Short Depression Scale
Time Frame: 4 weeks post-injury
This is a 10-item, 4-point Likert scale questionnaire assessing the level of depression symptoms in the past week. A higher score indicate worse outcome. Total scores can range from 0 to 30. A higher score indicate worse outcome.
4 weeks post-injury
Child and Adolescent Mindfulness Measure
Time Frame: 4 weeks post-injury
The Child and Adolescent Mindfulness Measure is a validated, 10-item, 5-point Likert scale questionnaire. A higher score indicate better outcome.
4 weeks post-injury
Functional Connectivity measured by Resting-State Functional MRI
Time Frame: 72 hours and 4th week post-injury
A subset of 60 participants will undergo a magnetic resonance imaging scan (MRI), which includes a resting-state functional MRI to assess function connectivity. To measure intra- and interconnectivity between regions of interest (default-mode network) and regions across the brain, will be measured. To calculate functional connectivity per participant, the mean blood-oxygen-level dependent (BOLD) signal time series will be extracted for each individual seed-region. Then, the correlation coefficients between the time series of each seed region will be grouped into functional connectivity maps. The functional connectivity maps will be converted into z-scores for normality and used for the statistical analysis. Whole-brain and region of interest functionally connectivity analysis will be conducted.
72 hours and 4th week post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Eastern Ontario

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ottawa
Academic Health Science Centres
Mobio Interactive PTE LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrée-Anne Ledoux, PhD, Children's Hospital of Eastern Ontario Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share the study protocol and statistical analysis plan.

IPD Sharing Time Frame

These documents will be shared once the protocol is published, approximately 6 months from now.

IPD Sharing Access Criteria

The protocol will be accessible online and through Trials.gov.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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