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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based intervention | Experimental |
| |
| Health education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Molly Cairncross, PhD | Contact | 1-778-782-7458 | mcairncr@sfu.ca | |
| Nina Andres | Contact | nina.andres@bcchr.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital Research Institute | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| 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. |
|
| 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) |
| 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) |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |