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

6. Juli 2026 aktualisiert von: Molly Cairncross

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

72

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Molly Cairncross, PhD
  • Telefonnummer: 1-778-782-7458
  • E-Mail: mcairncr@sfu.ca

Studieren Sie die Kontaktsicherung

Studienorte

  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • BC Children's Hospital Research Institute
        • Kontakt:
          • Molly Cairncross, PhD
          • Telefonnummer: 1-778-782-7458
          • E-Mail: mcairncr@sfu.ca

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Health education
Verhalten: 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: Achtsamkeitsbasierte Intervention
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Eligibility
Zeitfenster: pre-enrollment
% screened that are eligible
pre-enrollment
Recruitment rate
Zeitfenster: at randomization
% eligible participants randomized
at randomization
Treatment Adherence
Zeitfenster: post-intervention questionnaires (Week 8)
% participants who complete 70% of the intervention
post-intervention questionnaires (Week 8)
Retention
Zeitfenster: post-intervention questionnaires (Week 8)
% participants who complete follow-up assessment
post-intervention questionnaires (Week 8)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Treatment credibility and expectancy
Zeitfenster: 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.
7-14 days post-enrollment
Treatment Satisfaction
Zeitfenster: 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.
Post-intervention questionnaires (Week 8)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pediatric Quality of Life Inventory
Zeitfenster: 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.
pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)
Mild Traumatic Brain Injury Symptom Burden
Zeitfenster: 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.
pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)
Anxiety
Zeitfenster: 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.
pre-randomization (week 0) and post-intervention (week 8)
Depression
Zeitfenster: 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
pre-randomization (week 0) and post-intervention (week 8)
Pain intensity, distress, and location
Zeitfenster: 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.
pre-randomization (week 0) and post-intervention (week 8)
Mindfulness
Zeitfenster: 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.
pre-randomization (week 0) and post-intervention (week 8)
Avoidance behaviour
Zeitfenster: 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.
pre-randomization (week 0) and post-intervention (week 8)
Psychological flexibility
Zeitfenster: 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.
pre-randomization (week 0) and post-intervention (week 8)
Symptom Interference
Zeitfenster: 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.
pre-randomization (week 0) and post-intervention (week 8)
Personality traits
Zeitfenster: 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.
pre-intervention questionnaires (Week 0)
Global Impression of Change
Zeitfenster: 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.
post-intervention questionnaires (Week 8)
The Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale
Zeitfenster: 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.
pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Molly Cairncross

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

31. Mai 2028

Studienabschluss (Geschätzt)

31. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

10. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H25-01673

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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