Mindfulness-Based Intervention for Concussions

(MBI-4-mTBI Trial)

Not yet recruiting at 4 trial locations

Overseen By Tyrus Crawford

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Eastern Ontario

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.

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

Participants presenting to five PERC EDs after sustaining a direct or indirect head injury

Score ≥6 on the 5P rule

I have been diagnosed with a concussion.

Exclusion Criteria

I needed surgery, breathing support, or intensive care for a brain condition.

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)

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?

Group I: Mindfulness Intervention + Usual Care Experimental Treatment 1 Intervention

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).

Group II: Cognitive Sham + Usual care Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital of Eastern Ontario

Lead Sponsor

Trials

134

Recruited

61,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Montreal Children's Hospital of the MUHC

Collaborator

Trials

32

Recruited

117,000+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

British Columbia Children's Hospital

Collaborator

Trials

27

Recruited

15,600+

Stollery Children's Hospital

Collaborator

Trials

25

Recruited

25,900+