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NCT Number: NCT07698015

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Location contact

Molly Cairncross, PhD

CONTACT

[email protected]

1-778-782-7458

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Eligibility

    Time frame: pre-enrollment

    % screened that are eligible

  2. Recruitment rate

    Time frame: at randomization

    % eligible participants randomized

  3. Treatment Adherence

    Time frame: post-intervention questionnaires (Week 8)

    % participants who complete 70% of the intervention

  4. Retention

    Time frame: post-intervention questionnaires (Week 8)

    % participants who complete follow-up assessment

Secondary outcomes

  1. Treatment credibility and expectancy

    Time frame: 7-14 days post-enrollment

    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.

  2. Treatment Satisfaction

    Time frame: Post-intervention questionnaires (Week 8)

    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.

Other outcomes

  1. Pediatric Quality of Life Inventory

    Time frame: pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)

    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.

  2. Mild Traumatic Brain Injury Symptom Burden

    Time frame: pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)

    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.

  3. Anxiety

    Time frame: pre-randomization (week 0) and post-intervention (week 8)

    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.

  4. Depression

    Time frame: pre-randomization (week 0) and post-intervention (week 8)

    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

  5. Pain intensity, distress, and location

    Time frame: pre-randomization (week 0) and post-intervention (week 8)

    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.

  6. Mindfulness

    Time frame: pre-randomization (week 0) and post-intervention (week 8)

    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.

  7. Avoidance behaviour

    Time frame: pre-randomization (week 0) and post-intervention (week 8)

    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.

  8. Psychological flexibility

    Time frame: pre-randomization (week 0) and post-intervention (week 8)

    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.

  9. Symptom Interference

    Time frame: pre-randomization (week 0) and post-intervention (week 8)

    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.

  10. Personality traits

    Time frame: pre-intervention questionnaires (Week 0)

    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.

  11. Global Impression of Change

    Time frame: post-intervention questionnaires (Week 8)

    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.

  12. The Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale

    Time frame: pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Molly Cairncross, PhD

CONTACT

[email protected]

1-778-782-7458

Nina Andres

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Molly Cairncross

Other

Registry information

Official study title

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

Acronym: RESET

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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