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Mindfulness-Based Intervention for Concussion

(RESET Trial)

MC
NA
Overseen ByNina Andres
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Molly Cairncross
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Concussion or mild traumatic brain injury (mTBI) is a major public health concern. Most adolescents will recover from mTBI without complication; however, a sizeable minority experience symptoms that last more than one most post-injury (i.e., persisting symptoms after concussion). Few evidence-based treatments exist for adolescents with persisting symptoms after concussion. Mindfulness-based interventions (MBIs) are effective for treating a wide range of mental and physical health conditions that overlap with post-concussion symptoms. Participants will participate in an 8-week smartphone app-based MBI or a health education program as a control. The study will determine the practicality of doing a larger study to evaluate the effectiveness of the MBI by assessing participants' level of interest, view of intervention helpfulness, and their completion of all the components of the study.

Are You a Good Fit for This Trial?

This trial is for adolescents who have had a concussion or mild traumatic brain injury and are still experiencing symptoms more than one month after the injury. Participants should be able to use a smartphone app.

Inclusion Criteria

I still have significant symptoms after my concussion.
I have been diagnosed with a concussion or mild brain injury after a structured interview.
English proficiency
See 2 more

Exclusion Criteria

Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of psychiatric disorders or psychiatric symptoms contraindicated for mindfulness-based interventions (e.g., psychosis)
Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., <2 weeks post-injury)

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-based intervention

Trial Overview

The study compares an 8-week mindfulness program delivered via smartphone app with a health education program. The goal is to see if the mindfulness approach helps manage ongoing symptoms better than standard health education.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-based interventionExperimental Treatment1 Intervention
Group II: Health educationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Molly Cairncross

Lead Sponsor

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