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

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 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, medianIQR age=15.2813.66-16.19 years, 38.8% female) or the Sham group (n=50, medianIQR age=14.9213.32-16.71 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