Smartphone App–Delivered Mindfulness-Based Intervention for Concussion in Adolescents (MBI-4-mTBI): A Feasibility Randomized Controlled Trial (Preprint)
Notice bibliographique
Résumé
BACKGROUND Persisting symptoms affect about one-third of youth following concussion. Mental health history, distress, and coping style are key predictors of prolonged recovery. Early and scalable psychological interventions, such as mindfulness-based intervention (MBI) delivered via smartphones, may improve patients’ ability to regulate their emotions and neurophysiologically recover, reducing overall symptom burden. However, no digital therapeutic (DTx) trials in adolescents experiencing concussion exist. OBJECTIVE This study primarily aimed to assess the feasibility of conducting a larger randomized controlled trial (RCT) evaluating the effectiveness of a DTx-MBI in adolescents with a concussion compared to an attention-matched sham intervention. METHODS This was a Health Canada-regulated, parallel-group, blinded, single-crossover feasibility RCT. Adolescents aged 12 to <18 years presenting to a Pediatric Emergency Department or interdisciplinary concussion clinic within 7 days of a physician-diagnosed concussion were approached for participation from November 2022 to June 2024. After providing consent, participants were randomized (1:1), stratified by sex, to either the experimental group (DTx-MBI) or control group (sham, attention-matched math puzzle game). The DTx-MBI was delivered via AmDTx platform (Mobio Interactive Pte Ltd, Singapore) as a custom-designed 4-to-8-week program of 8 standardized modules for adolescents with concussion, including audio-recorded guided mindfulness exercises, goal setting, journaling, and psychoeducation. The control intervention, delivered through the same interface, excluded mindfulness content and instead featured the open-source game “2048”. Participants in both groups were encouraged to engage with the app for at least 10 minutes/day, at least 4 days/week. Feasibility criteria to support progression to a full-scale RCT included: eligibility rate >40% of those screened; recruitment rate >50% of eligible participants randomized; intervention credibility >70% scoring above the midpoint on the Credibility and Expectancy Questionnaire at 1 week; retention >75% of randomized participants completing 4-week outcomes; and adherence >70% completing 10 minutes of intervention on at least 4 days/week for 4 weeks. RESULTS 124/195 (63.6%) screened youth met eligibility criteria. Of these, 99/124 (79.8%) consented and were randomized to either DTx-MBI group (n=49, median[IQR] age=15.28[13.66-16.19] years, 38.8% female) or the Sham group (n=50, median[IQR] age=14.92[13.32-16.71] years, 40.0% female). Credibility was high, with 62/83 (74.7%) of participants scoring above the credibility midpoint (DTx-MBI: 75.0%; Sham: 74.4%). Retention was strong, with 89/99 (89.9%) of participants completing the 4-week outcomes (DTx-MBI: 89.8%; control: 90.0%). Overall adherence was moderate [54/99 (54.5%); DTx-MBI: 59.2%; control: 50.0%], and a little higher among outcome assessment completers [53/89 (59.6%); DTx-MBI: 63.6%; Sham: 55.6%]. Feasibility indicators were similar between groups. CONCLUSIONS This feasibility trial supports the implementation of a larger RCT, with modifications to enhance adherence, to rigorously evaluate the clinical efficacy of the DTx-MBI. By targeting modifiable psychological risk factors through a scalable digital platform, DTx-MBI could be a low-burden, cost-effective adjunct to pediatric concussion care. CLINICALTRIAL NCT05105802 INTERNATIONAL REGISTERED REPORT RR2-10.2196/57226
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,014 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».