Previously submitted to: JMIR Mental Health (no longer under consideration since Dec 06, 2022)
Date Submitted: Dec 5, 2022
Open Peer Review Period: Dec 5, 2022 - Dec 6, 2022
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Acceptability, Usability, and Credibility of a Mindfulness-Based Digital Therapeutic for Pediatric Concussion: A Mixed-Method Study
ABSTRACT
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.
Citation
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