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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
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Arm Title
Cognitive Sham Application + Usual Care
Arm Type
Active Comparator
Arm 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. 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.
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
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
Title
Retention
Description
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
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
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
Title
Health and Behaviour Inventory
Description
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.
Time Frame
2 and 4 weeks post-injury
Title
Post-Concussion Symptom Inventory (PCSI)
Description
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.
Time Frame
2 and 4 weeks post-injury
Title
Self-Efficacy Questionnaire for Children
Description
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.
Time Frame
4 weeks post-injury
Title
NIH Toolbox Cognitive Battery
Description
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.
Time Frame
4 weeks post-injury
Title
The Connor-Davidson Resilience Scale-10
Description
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.
Time Frame
4 weeks post-injury
Title
General Anxiety Disorder 7-items (GAD)
Description
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.
Time Frame
4 weeks post-injury
Title
Center for Epidemiologic Studies Short Depression Scale
Description
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.
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
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.
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
No
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
Email
aledoux@cheo.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tyrus Crawford
Phone
613-737-7600
Email
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
Email
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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