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

6 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Molly Cairncross, PhD
  • Numero di telefono: 1-778-782-7458
  • Email: mcairncr@sfu.ca

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Children's Hospital Research Institute
        • Contatto:
          • Molly Cairncross, PhD
          • Numero di telefono: 1-778-782-7458
          • Email: mcairncr@sfu.ca

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Health education
Comportamentale: 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.
Sperimentale: Intervento basato sulla consapevolezza
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Eligibility
Lasso di tempo: pre-enrollment
% screened that are eligible
pre-enrollment
Recruitment rate
Lasso di tempo: at randomization
% eligible participants randomized
at randomization
Treatment Adherence
Lasso di tempo: post-intervention questionnaires (Week 8)
% participants who complete 70% of the intervention
post-intervention questionnaires (Week 8)
Retention
Lasso di tempo: post-intervention questionnaires (Week 8)
% participants who complete follow-up assessment
post-intervention questionnaires (Week 8)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment credibility and expectancy
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pediatric Quality of Life Inventory
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Molly Cairncross

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 maggio 2028

Completamento dello studio (Stimato)

31 maggio 2028

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H25-01673

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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