Background: Eight-week mindfulness-based interventions (MBIs) have a beneficial impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who do not have in-person MBIs available in their communities.
Objective: This paper outlines the rationale, development, and design of a randomized controlled trial comparing the effects of an MBI delivered in person or via eHealth in adolescents with a chronic illness. Quantitative outcomes will include mindfulness skills acquisition (primary outcome), effects of the MBI on self-reported mood, anxiety, self-esteem, illness perception, and physiological stress (via salivary cortisol), and qualitative outcomes will include individual practice, participant appreciation, and adaptation of the MBI for eHealth.
Methods: This is a randomized noninferiority mixed methods study comparing 2 MBI arms: in-person and eHealth. Participants are eligible to participate if they are aged 13 to 18 years, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study, and are currently followed by a health care provider. Each participant will receive an adapted 8-week MBI delivered either in person at a tertiary pediatric hospital or via a secure audio-visual platform allowing group interactions in real time. Groups will be facilitated by 2 experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform and through semistructured interviews, participant log books, facilitator log books, and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model.
Results: Data collection is currently underway. Data analysis, manuscript writing, and additional publications are expected to be completed in the winter and spring of 2018.
Conclusions: Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception, and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of 8-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers.
Trial registration: ClinicalTrials.org NCT03067207; https://clinicaltrials.gov/ct2/show/NCT03067207 (archived by WebCite at http://www.webcitation.org/6v4ZK8RBH).
Keywords: adolescent; chronic illness; eHealth; meditation; mindfulness; protocol; randomized.
©Nicholas Chadi, Miriam Kaufman, Elli Weisbaum, Catherine Malboeuf-Hurtubise, Sara Ahola Kohut, Christine Viner, Jake Locke, Dzung X Vo. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.11.2017.