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

Primary Purpose

Concussion, Mild

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Mindfulness-Based Intervention

Cognitive Sham + Usual Care

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

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Intervention

Cognitive Sham Application + Usual Care

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Adherence to Treatment

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

Secondary Outcome Measures

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.

Health and Behaviour Inventory

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.

Post-Concussion Symptom Inventory (PCSI)

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.

Self-Efficacy Questionnaire for Children

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.

NIH Toolbox Cognitive Battery

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.

The Connor-Davidson Resilience Scale-10

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.

General Anxiety Disorder 7-items (GAD)

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.

Center for Epidemiologic Studies Short Depression Scale

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.

Child and Adolescent Mindfulness Measure

The Child and Adolescent Mindfulness Measure is a validated, 10-item, 5-point Likert scale questionnaire. A higher score indicate better outcome.

Functional Connectivity measured by Resting-State Functional MRI

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.

Full Information

NCT ID

NCT05105802

First Posted

October 8, 2021

Last Updated

February 6, 2023

Sponsor

Children's Hospital of Eastern Ontario

Collaborators

Mobio Interactive PTE LTD, University of Ottawa, Academic Health Science Centres

1. Study Identification

Unique Protocol Identification Number

NCT05105802

Brief Title

Mindfulness-Based Intervention for Mild Traumatic Brain Injury

Acronym

MBI-4-mTBI

Official Title

Mindfulness-Based Intervention for Mild Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 4, 2022 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital of Eastern Ontario

Collaborators

Mobio Interactive PTE LTD, University of Ottawa, Academic Health Science Centres

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Concussion, Mild

Keywords

mild traumatic brain injury, intervention, treatment, persistent post-concussive symptoms, quality of life, meditation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Double-blind randomized clinical trial with 2 groups

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Double-blind study

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness Intervention

Arm Type

Experimental

Arm Description

Arm Title

Cognitive Sham Application + Usual Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-Based Intervention

Other Intervention Name(s)

MBI, AmDtx

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Sham + Usual Care

Other Intervention Name(s)

Cognitive Sham, Usual Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ease of Recruitment

Description

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

Title

Credibility Score (Credibility and Expectancy Questionnaire)

Description

Time Frame

1 week post-injury

Title

Retention

Description

Time Frame

4 weeks post-injury

Title

Adherence to Treatment

Description

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

Time Frame

4 weeks post-injury

Secondary Outcome Measure Information:

Title

Pediatric Quality of Life Inventory™ version 4.0

Description

Time Frame

4 weeks post-injury

Title

Health and Behaviour Inventory

Description

Time Frame

2 and 4 weeks post-injury

Title

Post-Concussion Symptom Inventory (PCSI)

Description

Time Frame

2 and 4 weeks post-injury

Title

Self-Efficacy Questionnaire for Children

Description

Time Frame

4 weeks post-injury

Title

NIH Toolbox Cognitive Battery

Description

Time Frame

4 weeks post-injury

Title

The Connor-Davidson Resilience Scale-10

Description

Time Frame

4 weeks post-injury

Title

General Anxiety Disorder 7-items (GAD)

Description

Time Frame

4 weeks post-injury

Title

Center for Epidemiologic Studies Short Depression Scale

Description

Time Frame

4 weeks post-injury

Title

Child and Adolescent Mindfulness Measure

Description

The Child and Adolescent Mindfulness Measure is a validated, 10-item, 5-point Likert scale questionnaire. A higher score indicate better outcome.

Time Frame

4 weeks post-injury

Title

Functional Connectivity measured by Resting-State Functional MRI

Description

Time Frame

72 hours and 4th week post-injury

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrée-Anne Ledoux, PhD

Phone

613-737-7600

Ext

4104

aledoux@cheo.on.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Tyrus Crawford

Phone

613-737-7600

tcrawford@cheo.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrée-Anne Ledoux, PhD

Organizational Affiliation

Children's Hospital of Eastern Ontario Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Eastern Ontario

City

Ottawa

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Candice McGahern

Phone

613-737-7600

Ext

4111

cmcgahern@cheo.on.ca

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Mindfulness-Based Intervention for Mild Traumatic Brain Injury

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