Rehabilitation, Education, and SElf-management for Adolescents After Mild Traumatic Brain Injury
RESET
A Decentralized, Investigator Blinded, Randomized, Parallel-group Study to Determine the Feasibility of an 8-week Smart-phone App Delivered Mindfulness- Based Intervention Versus a Health Education Program for Adolescents With Persisting Symptoms After Concussion/mTBI
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
Study Completion
Last participant's last visit for all outcomes
May 31, 2028
July 13, 2026
June 1, 2026
1.7 years
June 10, 2026
July 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Eligibility
% screened that are eligible
pre-enrollment
Recruitment rate
% eligible participants randomized
at randomization
Treatment Adherence
% participants who complete 70% of the intervention
post-intervention questionnaires (Week 8)
Retention
% participants who complete follow-up assessment
post-intervention questionnaires (Week 8)
Secondary Outcomes (2)
Treatment credibility and expectancy
7-14 days post-enrollment
Treatment Satisfaction
Post-intervention questionnaires (Week 8)
Other Outcomes (12)
Pediatric Quality of Life Inventory
pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)
Mild Traumatic Brain Injury Symptom Burden
pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)
Anxiety
pre-randomization (week 0) and post-intervention (week 8)
- +9 more other outcomes
Study Arms (2)
Mindfulness-based intervention
EXPERIMENTALHealth education
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 12-18
- Structured interview confirming a concussion/mTBI or suspected concussion/mTBI diagnosis according to the American Congress of Rehabilitation Medicine definition
- Concussion/mTBI occurred 1-12 months prior to randomization
- Persisting symptoms after concussion as demonstrated by a score \>75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group
- English proficiency
You may not qualify if:
- 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)
- Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., \<2 weeks post-injury).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Molly Cairncrosslead
Study Sites (1)
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 10, 2026
First Posted
July 13, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
July 13, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share