An interventional study of Mindfulness-based intervention and Health Education in Brain Concussion, Mild Traumatic Brain Injury and Concussion, sponsored by Molly Cairncross. Not yet recruiting at 1 site in Canada. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Molly Cairncross · Not applicable, Interventional, and Treatment
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 72 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →This is the only study on the registry with Molly Cairncross as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Mindfulness-based intervention
Behavioral: Health Education
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
% screened that are eligible
Time frame: pre-enrollment
Recruitment rate
% eligible participants randomized
Time frame: at randomization
Treatment Adherence
% participants who complete 70% of the intervention
Time frame: post-intervention questionnaires (Week 8)
Retention
% participants who complete follow-up assessment
Time frame: post-intervention questionnaires (Week 8)
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.
Time frame: 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.
Time frame: Post-intervention questionnaires (Week 8)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for May 2028, 20 months later.
Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 20 months is below that.
Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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