Smartphone App-Delivered Mindfulness-Based Intervention for Concussion in Adolescents (MBI-4-mTBI): Feasibility Randomized Controlled Trial.

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 with 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 the control group (sham, attention-matched math puzzle game). The DTx-MBI was delivered via the 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 (CEQ) 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: A total of 124 out of 195 (63.6%) screened youth met eligibility criteria. Of these, 99/124 (79.8%) consented and were randomized to either the DTx-MBI group (n=49, median [IQR] age=15.28 [13.66-16.19] years, 30 [61.2%] female) or the Sham group (n=50, median [IQR] age=14.92 [13.32-16.71] years, 30 [60.0%] 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.