Real-Time Cardiac Biofeedback Intervention: Experiences of Patient and Public Involvement in a Randomized Controlled Trial.

Background: Patient and public involvement (PPI) is crucial for enhancing research quality and relevance and addressing health inequalities. PPI ensures that studies tackle relevant and meaningful questions, as there is a recognized need by the research community to document and share PPI studies to advance the field and encourage the adoption of such activities. Objective: The study aimed to provide a detailed report on the PPI activities undertaken to develop and implement a randomized controlled trial of a novel therapeutic tool designed to increase interoception and metacognition (ie, the Interoceptive Insight and Metacognitive Efficacy beliefs [InMe] trial). Methods: The InMe trial integrated insights from experts by experience, as well as from clinical and academic experts. This collaborative approach resulted in the development of a comprehensive trial across 4 main stages-design, delivery, results interpretation, and future planning. Results: Here, we highlighted the unique insights and the added value in incorporating PPI activities into our trial development and implementation, while reporting challenges and shortcomings that were identified throughout this process. Conclusions: PPI activities within the InMe trial led to meaningful changes, while collaborators expressed satisfaction and increased interest in interoception research. Further improvements on how to best support experts by experience when sharing their experiences were also identified.