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

6. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Health education
Adfærdsmæssigt: 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.
Eksperimentel: Mindfulness-baseret intervention
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment credibility and expectancy
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pediatric Quality of Life Inventory
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Molly Cairncross

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. maj 2028

Studieafslutning (Anslået)

31. maj 2028

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H25-01673

Plan for individuelle deltagerdata (IPD)

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