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Mindfulness-Based Intervention for Concussion (MBI-4-mTBI Trial)
MBI-4-mTBI Trial Summary
This trial will test whether mindfulness can help reduce symptoms and improve quality of life for adolescents with concussions.
MBI-4-mTBI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MBI-4-mTBI Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Mindfulness Intervention
- Group 2: Cognitive Sham Application + Usual Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is the minimum age of participants for this trial restricted to 18 years or older?
"We are looking for participants between the ages 12 and 18 to join this clinical trial."
What is the aim of this experiment?
"The purpose of this experiment, which is to be carried out over a four-week period after the injury, is to assess Ease of Recruitment. Secondary objectives involve employing the NIH Toolbox Cognitive Battery (which measures cognitive functioning such as executive function and memory using standard scores) The Center for Epidemiologic Studies Short Depression Scale (a 10-item questionnaire created to rate depression symptoms in the past week with higher values indicating worse outcomes), and Pediatric Quality of Life Inventory™ version 4.0 (a 23-item Likert scale that produces both total score & domain scores, each ranging from 0 - 92). A higher"
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