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Clinical Trials in Canada / NCT07698015
Starting soon Not applicable

Rehabilitation, Education, and SElf-management for Adolescents After Mild Traumatic Brain Injury

NCT07698015 · tracked via the Priya Life Science Canada tracker
Sponsor
Molly Cairncross
Phase
Not applicable
Started
2026-09-01
Last updated
2026-07-13

Condition(s) studied

Brain ConcussionMild Traumatic Brain InjuryConcussion

Investigational drug(s) / intervention(s)

Mindfulness-based interventionHealth Education

Mindfulness-based intervention: The mindfulness-based intervention (MBI) is delivered via a smartphone application called Dawn. The MBI consists of 8-week MBI program developed to meet the needs of adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and guided mindfulness exercises. The goal of this intervention is to support better coping with symptoms.

Health Education: The health education program is delivered via a smartphone application called Dawn. It is an 8-week program designed to deliver information about health behaviors (e.g., sleep, exercise, nutrition, social support) that is inline with clinical practice guidelines for adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and health behavior tracking exercises. The goal of this intervention is to provide a credible, time- and attention-matched control group.

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 12-18 2. Structured interview confirming a concussion/mTBI or suspected concussion/mTBI diagnosis according to the American Congress of Rehabilitation Medicine definition 3. Concussion/mTBI occurred 1-12 months prior to randomization 4. Persisting symptoms after concussion as demonstrated by a score \>75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group 5. English proficiency Exclusion Criteria: 1. Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of a psychiatric disorders or psychiatric symptoms that may be contraindicated for mindfulness-based interventions (e.g., psychosis) 2. Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., \<2 weeks post-injury).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
BC Children's Hospital Research Institute Vancouver British Columbia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07698015 on ClinicalTrials.gov ↗ ← All trials in Canada