Mindfulness-Based Intervention for Concussions
(MBI-4-mTBI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a mindfulness-based intervention, delivered through an app, can aid young people in recovering from concussions. The study compares this new approach with usual care, which involves resting and gradually returning to activities. Participants will use the app for activities like guided meditations and mood check-ins for a few minutes each day. The trial seeks teens who have had a concussion in the last two days and are fluent in English or French. This app-based option aims to make recovery support more accessible and convenient for families. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance concussion recovery for others.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this mindfulness-based intervention is safe for youth with concussions?
Research has shown that mindfulness-based activities are generally safe for everyone, including kids and teens. Studies have found that activities like Mindfulness-Based Stress Reduction can improve mental health and help people recover from difficult times, which is especially important after a concussion.
In previous studies, participants have handled mindfulness activities well, with no major reports of negative side effects. Even those with mild brain injuries usually do not experience adverse reactions, which reassures anyone concerned about trying something new.
Mindfulness practices are often used in therapies already approved for other conditions, enhancing their safety profile. They help people manage stress and emotions without medication, reducing the risk of side effects that drugs might cause.
In summary, mindfulness-based treatments have a strong record of safety for people to try, including young people recovering from concussions.12345Why are researchers excited about this trial?
Researchers are excited about the Mindfulness-Based Intervention for concussions because it offers a fresh approach to recovery by incorporating mindfulness practices. Unlike standard care, which primarily focuses on rest and gradual reintroduction of activities, this intervention uses a custom app to guide patients through meditations and mood check-ins. This method aims to actively engage patients in their recovery process, potentially enhancing emotional well-being and reducing stress, which could speed up overall recovery. The app-based delivery makes it accessible and easy to integrate into daily life, setting it apart from more traditional, passive recovery methods.
What evidence suggests that this Mindfulness-Based Intervention is effective for concussions?
Research has shown that mindfulness practices can aid recovery from mild brain injuries, such as concussions. In this trial, participants in the Mindfulness Intervention + Usual Care arm will engage in a 4-week custom-made mindfulness program. Studies have found that activities like Mindfulness-Based Stress Reduction (MBSR) can reduce mental fatigue and enhance cognitive skills. These practices also improve emotional resilience and regulation. For young people, mindfulness apps offer promise due to their accessibility and ease of integration into daily routines. Although more research is needed, early results suggest these practices could support concussion recovery.12678
Who Is on the Research Team?
Andrée-Anne Ledoux, PhD
Principal Investigator
Children's Hospital of Eastern Ontario Research Institute
Are You a Good Fit for This Trial?
This trial is for young individuals who have experienced a mild traumatic brain injury, such as a concussion. It's designed to help those looking for an accessible and low-cost treatment option that doesn't require in-person meetings or extensive time commitments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the MBI training or a sham cognitive game for 4 weeks, with daily app-based activities
Motivational Interview
Participants complete a motivational interview to increase adherence to the intervention
Open-label extension
Participants are offered the MBI program for an additional 4 weeks, with the control group having the option to crossover
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at Week 4 and Week 8
What Are the Treatments Tested in This Trial?
Interventions
- Mindfulness-Based Intervention
Trial Overview
The study is testing a mobile app-based Mindfulness-Based Intervention (MBI) against a cognitive sham (placebo-like intervention). The goal is to see if the MBI can be an effective, convenient, and affordable way to improve mental health after a concussion.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Experimental group: MBI training will consist of a 4-week custom-made program that includes 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 participant 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 a week, over a period of 4 weeks (with the option to continue for 8 weeks).
Usual care recommends that patients refrain from physical and cognitive activities for 24-48 hours after concussion. After the initial rest period, it is recommended to introduce low to moderate levels of physical and cognitive activity at a level that does not result in recurrence or exacerbation of symptoms. Patients must refrain from any activities that increase the risk of re-injury (body contact or risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. This arm is considered as active participant with the sham app (cognitive math game called "2048") delivered via the same app as the MBI, but without the mindfulness content. Participants will be encouraged to engage in the app-based activities for at least 10 minutes daily, with a minimum of 4 days per week, over a period of 4 weeks. Participants will also be asked questions about their stress, emotions, and symptoms.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Eastern Ontario
Lead Sponsor
The Hospital for Sick Children
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
University of Ottawa
Collaborator
British Columbia Children's Hospital
Collaborator
Stollery Children's Hospital
Collaborator
Citations
Smartphone App–Delivered Mindfulness-Based Intervention ...
Delivered mindfulness-based intervention for mild traumatic brain injury in adolescents: protocol for a feasibility randomized controlled trial.
Mindfulness-Based Intervention for Pediatric Mild ...
Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation.
The Effects of Mindfulness-Based Interventions on ...
Research shows that MBSR mainly reduces mental fatigue symptoms in mTBI patients, and GOALS tend to improve their cognitive function.
“Hidden Gains”? Measuring the Impact of Mindfulness ...
Mindfulness-based interventions can support recovery from mild traumatic brain injury (mTBI). Although measurement is a key determinant of outcomes, there is no ...
The outcomes of mindfulness-based interventions for ...
This literature review aims to evaluate the effectiveness of mindfulness-based interventions (MBIs) for adults following a traumatic brain ...
Mindfulness-based stress reduction as perceived by ...
Mindfulness-based stress reduction (MBSR) has shown promising results in quantitative studies as a complementary treatment for pathological mental fatigue (PMF ...
Psychiatric outcomes after mild concussion by treatment ...
We examined if patients who received immediate treatment less than one week after a mild concussion had a different risk for subsequent depression or anxiety.
Yoga, Meditation, and Mindfulness for Treatment of ...
Mindfulness-based cognitive therapy improves depression symptoms after traumatic brain injury. ... intervention for older adults with mild ...
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