Growing pains: Lessons learned from a failed mobile mindfulness clinical trial for patients with complex care needs.

This paper discusses lessons learned from a failed clinical trial investigating the use of a mobile application (app) to deliver a mindfulness intervention to middle-aged and older adults receiving services at a rehabilitation hospital in Ontario, Canada. A randomized controlled trial with 82 participants was planned, with the experimental group receiving access to a mindfulness app and a wait-list control group receiving access to the app after 4 weeks; however, the study could not be completed due to low recruitment rates. This implementation failure was considered from the perspective of the PARIHS framework. More specifically, Three key recruitment challenges were identified, and recommendations for future research provided. Firstly, the increasingly complex care needs of the study population appeared to influence eligibility; it would be beneficial for future research to consider adopting strategies to better understand the needs of the target population. Secondly, participants' stage of care and readiness of change likely negatively influenced compliance and retention in this study, and should be assessed in future research. Finally, a lack of clinician integration into the research team negatively impacted recruitment in this study; future studies should consider integrating direct service providers into the research team as this may increase buy-in and referral rates. The challenges and recommendations outlined can inform design and implementation of future studies in this area.