Concussion, MildMBI-4-mTBINCT05105802
Mindfulness-Based Intervention for Mild Traumatic Brain Injury
A study testing Mindfulness-Based Intervention in people with Concussion, Mild, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2022to 6 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Concussion, Mild
- Being tested
- Mindfulness-Based Intervention, Cognitive Sham + Usual Care
- Keywords
- mild traumatic brain injury, intervention, treatment, persistent post-concussive symptoms, quality of life, meditation
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based InterventionBehavioural
Also called MBI, AmDtx
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 CareBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | 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. Receives: Behavioral: Mindfulness-Based Intervention |
| Cognitive Sham Application + Usual Care | Active comparator | 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. Receives: Behavioral: Cognitive Sham + Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks post-injury
Adherence to Treatment
Calculated based on the time spent on the app. A higher score means better adherence.
Measured: 4 weeks post-injury
Secondary outcomes (10)
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.
Measured: 4 weeks post-injury
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.
Measured: 2 and 4 weeks post-injury
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.
Measured: 2 and 4 weeks post-injury
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.
Measured: 4 weeks post-injury
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.
Measured: 4 weeks post-injury
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.
Measured: 4 weeks post-injury
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.
Measured: 4 weeks post-injury
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.
Measured: 4 weeks post-injury
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.
Measured: 4 weeks post-injury
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.
Measured: 72 hours and 4th week post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start4 Oct 2022
- Primary completion6 Jul 2024
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized clinical trial with 2 groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Mobio Interactive PTE LTD, University of Ottawa, Academic Health Science Centres
- Responsible party
- Principal investigator, Andree-Anne Ledoux, Children's Hospital of Eastern Ontario
- Investigators
- Andrée-Anne Ledoux, PhD, Principal investigator, Children's Hospital of Eastern Ontario Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105802
- Sponsor's protocol ID
- 20190441
- Acronym
- MBI-4-mTBI
- Status last verified
- Feb 2025
- First submitted
- 8 Oct 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the study protocol and statistical analysis plan.
Publications
Brown O, Smith A, Cairncross M, Dodd AB, Goldfield GS, Gray C, Harris AD, Jaworska N, Saab BJ, Sicard V, Silverberg ND, Walker LAS, Zemek R, Ledoux AA. The impact of an app-delivered mindfulness-based intervention on resting-state functional connectivity in pediatric concussion: a pilot study. Front Neurosci. 2026 Sep 17;20:1771767. doi: 10.3389/fnins.2026.1771767. eCollection 2026.
PubMed 42824171Ledoux AA, Zemek R, Cairncross M, Silverberg N, Sicard V, Barrowman N, Goldfield G, Gray C, Harris AD, Jaworska N, Reed N, Saab BJ, Smith A, Walker L. Smartphone App-Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 11;13:e57226. doi: 10.2196/57226.
PubMed 38602770
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Intervention for Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05105802
- Acronym / sponsor ID
- MBI-4-mTBI / 20190441
- Conditions
- Concussion, Mild
- Keywords
- mild traumatic brain injury, intervention, treatment, persistent post-concussive symptoms, quality of life, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Mobio Interactive PTE LTD, University of Ottawa, Academic Health Science Centres
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 6 Jul 2024 (actual)
- Study completion
- 6 Jul 2024 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized clinical trial with 2 groups
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: Mindfulness-Based InterventionMBI 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. |
| Cognitive Sham Application + Usual Care | Active comparator | Behavioral: Cognitive Sham + Usual CareUsual 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based InterventionAlso: MBI, AmDtxUsing 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. | Behavioural | Mindfulness Intervention |
| Cognitive Sham + Usual CareAlso: Cognitive Sham, Usual CareUsual 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. | Behavioural | Cognitive Sham Application + Usual Care |
Primary outcome
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.
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.
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.
Adherence to Treatment
Time frame: 4 weeks post-injury
Calculated based on the time spent on the app. A higher score means better adherence.
10 secondary outcomes
Pediatric Quality of Life Inventory™ version 4.0
Time frame: 4 weeks post-injury
Health and Behaviour Inventory
Time frame: 2 and 4 weeks post-injury
Post-Concussion Symptom Inventory (PCSI)
Time frame: 2 and 4 weeks post-injury
Self-Efficacy Questionnaire for Children
Time frame: 4 weeks post-injury
NIH Toolbox Cognitive Battery
Time frame: 4 weeks post-injury
The Connor-Davidson Resilience Scale-10
Time frame: 4 weeks post-injury
General Anxiety Disorder 7-items (GAD)
Time frame: 4 weeks post-injury
Center for Epidemiologic Studies Short Depression Scale
Time frame: 4 weeks post-injury
Child and Adolescent Mindfulness Measure
Time frame: 4 weeks post-injury
Functional Connectivity measured by Resting-State Functional MRI
Time frame: 72 hours and 4th week post-injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 42824171Brown O, Smith A, Cairncross M, Dodd AB, Goldfield GS, Gray C, Harris AD, Jaworska N, Saab BJ, Sicard V, Silverberg ND, Walker LAS, Zemek R, Ledoux AA. The impact of an app-delivered mindfulness-based intervention on resting-state functional connectivity in pediatric concussion: a pilot study. Front Neurosci. 2026 Sep 17;20:1771767. doi: 10.3389/fnins.2026.1771767. eCollection 2026.
- Derived from this study: PubMed 38602770Ledoux AA, Zemek R, Cairncross M, Silverberg N, Sicard V, Barrowman N, Goldfield G, Gray C, Harris AD, Jaworska N, Reed N, Saab BJ, Smith A, Walker L. Smartphone App-Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 11;13:e57226. doi: 10.2196/57226.
- Individual participant dataSharing planned: Yes. We plan to share the study protocol and statistical analysis plan.
Related trials for Concussion, Mild
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Recruiting
EXercise-induced PhysioLogical Adaptations In Neurological Disorders
Epilepsy, Functional Neurological Disorder
Not yet recruiting
The PIONEER Comparative Effectiveness Study - Project 2
Head Injury Trauma, Traumatic Brain Injury, Mild
Recruiting
Neuromodulation and Neurorehabilitation for mTBI
Mild Traumatic Brain Injury, Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrée-Anne Ledoux, PhD principal investigator
Children's Hospital of Eastern Ontario Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention in people with Concussion, Mild, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of Recruitment (time frame: 48 hours post-injury). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105802, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.