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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Concussion; Mild Traumatic Brain Injury; Concussion
• Intervention / Treatment: Behavioral: Mindfulness-based intervention; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Molly Cairncross, PhD; Phone Number: 1-778-782-7458; Email: mcairncr@sfu.ca
• Study Contact Backup: Name: Nina Andres; Email: nina.andres@bcchr.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • BC Children's Hospital Research Institute
      • Contact: Molly Cairncross, PhD; Phone Number: 1-778-782-7458; Email: mcairncr@sfu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Health education	Behavioral: 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.
Experimental: Mindfulness-based intervention	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment credibility and expectancy	Proportion of participants who view the treatment as logical (credibility) and expect that it will help (expectancy) will be measured by the Credibility Expectancy Questionnaire. Scores range from 6-64 with higher scores reflecting higher treatment credibility and expectancy. A score above the midpoint will be considered acceptable.	7-14 days post-enrollment
Treatment Satisfaction	This Client Satisfaction Questionnaire is a validated, reliable, 8-item questionnaire used to measure client satisfaction with a particular program or services (range 8-32). Higher scores reflect better treatment satisfaction. A score above the scale midpoint on the Client Satisfaction Questionnaire will be considered acceptable.	Post-intervention questionnaires (Week 8)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life Inventory	The Pediatric Quality of Life Inventory (Peds-QL) will be the primary clinical endpoint for a future efficacy trial. The total scale will be used. Scores ranged from 0-100, with higher scores reflecting better health-related quality of life.	pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)
Mild Traumatic Brain Injury Symptom Burden	The Health and Behaviour Inventory (HBI) is a 20-item self- report questionnaire of post-concussion symptoms. We will calculate a total score by summing all items. The score ranges from 0-60, with higher scores reflecting higher symptom burden.	pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)
Anxiety	The Patient-Reported Outcomes Measurement Information System Pediatric Anxiety Short For 8a is a validated, reliable and sensitive to treatment-related changes tool that assesses anxiety symptoms in youth. T-scores will be calculated, with higher scores reflecting higher anxiety.	pre-randomization (week 0) and post-intervention (week 8)
Depression	The Patient-Reported Outcomes Measurement Information System Pediatric Depressive Symptoms Short Form 8a will be used to asses depression. It is a validated, reliable and sensitive to treatment-related changes tool that assesses depression symptoms in youth. T-scores will be calculated, with higher scores reflecting higher depression	pre-randomization (week 0) and post-intervention (week 8)
Pain intensity, distress, and location	A pain rating scale will be used to assess pain intensity, distress, and location. Pain intensity is scores on a scale from 0 to 10, with higher scores reflecting greater intensity. Pain distress is scored on a scale from 0 to 10, with higher scores reflecting greater pain related distress. Pain location will be scores by totaling the number of areas where the individual is affected by pain, with higher scores reflecting pain in more parts of the body.	pre-randomization (week 0) and post-intervention (week 8)
Mindfulness	Child Acceptance and Mindfulness Measure (CAMM) is a 10 item measure of dispositional mindfulness originally designed for use for youth aged 10-17. Scores range from 0-40, where higher scores correspond to higher train mindfulness.	pre-randomization (week 0) and post-intervention (week 8)
Avoidance behaviour	The Pediatric Fear Avoidance after Traumatic Brain Injury Questionnaire (PFAB-TBI) is a 16-item measure of fear-avoidance behaviours after traumatic brain injury in children and youth. Scores range from 0-48, with higher scores reflecting more fear avoidance behaviour.	pre-randomization (week 0) and post-intervention (week 8)
Psychological flexibility	The Avoidance and Fusion Questionnaire for Youth (AQ-Y8) is an 8-item measure that assesses psychological flexibility in youth ages 9-17. Scores range from 0-32, where higher scores indicate higher psychological inflexibility engendered by high levels of cognitive fusion and experiential avoidance.	pre-randomization (week 0) and post-intervention (week 8)
Symptom Interference	The PROMIS Pediatric Pain Interference consists of 13 items related to how pain interfere with a child's day-to-day life. Scores range from 0-30, where higher scores will reflect more symptom interference.	pre-randomization (week 0) and post-intervention (week 8)
Personality traits	The Five-Factor Model - Adolescent Personality Questionnaire (FFM-APQ) is a 25-item questionnaire, 5 for each personality trait tested with 12- to 17-year-olds. Subscale scores will be calculated for each trait, where higher scores reflect stronger trait endorsement.	pre-intervention questionnaires (Week 0)
Global Impression of Change	The Global Impression of Change (Score) is a single item asking participants to reflect on change post-intervention. Scores ranges from 1 to 7, with higher scores reflecting more positive change.	post-intervention questionnaires (Week 8)
The Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale	The PedsQL-MFS scale measures general fatigue, sleep/rest fatigue, and cognitive fatigue. Items are totaled and transformed to a 0-100 scale. Higher scores reflect fewer fatigue symptom.	pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)

Collaborators and Investigators

• Sponsor: Molly Cairncross

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: digital health; concussion; mild traumatic brain injury; mindfulness-based intervention; persisting symptoms after concussion
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion
• Other Study ID Numbers: H25-01673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No