Acceptability, Usability, and Credibility of a Mindfulness-Based Digital Therapeutic for Pediatric Concussion: A Mixed-Method Study (Preprint)

BACKGROUND A third of adolescents experiencing a concussion will suffer from persistent post-concussion symptoms lasting a month or beyond. The ability to cope with concussion symptoms, regulate emotions, and manage stress is an important determinant of risk for prolonged symptoms. Early psychological interventions, such as mindfulness-based interventions, might improve concussion recovery. OBJECTIVE This open-label mixed-methods pilot study assessed the acceptability and credibility of a mindfulness-based intervention delivered through a digital therapeutic (DTx; therapeutic smartphone app) for pediatric concussion. METHODS Participants aged 12-18 years were recruited from an emergency department within 48 hours of a concussion (acute cohort) or from a tertiary care clinic at least 1 month post-concussion (persistent symptom cohort). Participants completed a novel 4-week mindfulness-based intervention, for 10-15 min/day, at a minimum of 4 days/week. At 2 weeks post-concussion, participants completed a credibility questionnaire. At 4 weeks, participants completed questionnaires assessing satisfaction, usability, and working alliance, as well as a semi-structured phone interview. RESULTS 10 participants completed the study outcomes, including 7 acute (5 females; median IQR age=14.73 13.94,16.94 years and 3 persistent symptom patients (2 females; median IQR age=17.62 17.48,17.86 years). Across cohorts, half-way through the intervention, the treatment expectation was moderate (median=6.00 3.58,7.75, maximum possible=9.00). Moreover, the intervention was perceived as credible (median=6.50 6.83,8.75, maximum possible=9.00). At 4 weeks, the DTx was considered usable (median=70.00 55.00,82.50, maximum possible=100.00). Participants rated their satisfaction with the DTx (median=27.00 24.50,29.50, maximum possible=32.00) and the working alliance with the digital mindfulness guides (median=3.92 3.38-4.33, maximum possible=5.00) as high. Four themes were identified from the qualitative data: 1) positive attributes (including accessibility, ease of use, perceived effectiveness, variety of features, and meditation guides); 2) negative attributes (technical issues that acted as a barrier to use, and sounds and lights that were triggering headaches); 3) ideas for modifications; and 4) technical issues. CONCLUSIONS Adolescents were very satisfied with a mindfulness-based intervention delivered via a smartphone app and considered it to be usable and credible. Results inform modifications to the DTx, instructions, and mindfulness intervention, and potential ways to increase adherence by leveraging positive attributes. A randomized control trial will assess the effectiveness of the DTx to decrease the risk of persistent symptoms and reduce the symptom burden following pediatric concussion. The present mixed-methods study and the iterative approach to intervention design we are using will ensure better translation and impact of interventions for adolescents with concussions.