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Mindfulness-Based Intervention for Concussion (MBI-4-mTBI Trial)
N/A
Recruiting
Led By Andrée-Anne Ledoux, PhD
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours and 4th week post-injury
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether mindfulness can help reduce symptoms and improve quality of life for adolescents with concussions.
Who is the study for?
This trial is for adolescents aged 12-17 who've had a head injury within the last 48 hours and are showing signs of concussion. They must speak English, have internet access, and not require intensive care or have severe psychiatric disorders like schizophrenia.
What is being tested?
The study tests a mindfulness app designed to help with recovery from concussion against a sham cognitive app plus usual care. It aims to see if mindfulness can improve quality of life and reduce symptoms in teens after a brain injury.
What are the potential side effects?
Since this trial involves non-invasive interventions like apps for mindfulness training, side effects may be minimal but could include frustration or lack of improvement in symptoms compared to traditional treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours and 4th week post-injury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours and 4th week post-injury
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to Treatment
Credibility Score (Credibility and Expectancy Questionnaire)
Ease of Recruitment
+1 moreSecondary study objectives
Center for Epidemiologic Studies Short Depression Scale
Child and Adolescent Mindfulness Measure
Functional Connectivity measured by Resting-State Functional MRI
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness InterventionExperimental Treatment1 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.
Group II: Cognitive Sham Application + Usual CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Intervention
2020
N/A
~80
Find a Location
Who is running the clinical trial?
Children's Hospital of Eastern OntarioLead Sponsor
129 Previous Clinical Trials
60,329 Total Patients Enrolled
Mobio Interactive PTE LTDIndustry Sponsor
1 Previous Clinical Trials
67 Total Patients Enrolled
University of OttawaOTHER
221 Previous Clinical Trials
269,523 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a severe mental illness like schizophrenia. A diagnosis of anxiety or depression is not a problem.You have been hospitalized for a mental health condition in the past.You have a Glasgow Coma Scale score of 13 or lower.You are drunk or high when you come to the hospital, according to the doctor's judgment.You needed brain surgery, a breathing tube, or special care in the hospital.You have a history of head injury or fainting as the main cause.You went to CHEO's Emergency Department within 48 hours of getting a head injury.You are between 12 and 17.99 years old.You have a high score on a test that predicts ongoing issues after a concussion.You have abnormal results from standard brain scans, like a head CT.You have been seriously injured and needed to be treated in a hospital, operating room, or with sedation in the emergency room. Note that being admitted to the hospital for observation or ongoing concussion symptoms is not a problem.You have a severe, long-term delay in your ability to communicate due to neurological issues.You have a concussion, as defined by the Berlin consensus statement.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Intervention
- Group 2: Cognitive Sham Application + Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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