JMIR Publications

ABSTRACT

There has been a growth in the number of online trials of online interventions, adding to an increasing evidence base. However, there are challenges associated with such trials, which researchers must address. This discussion paper follows the structure of the Down Your Drink trial methodology paper, providing an update from the literature for each key trial parameter (recruitment, registration and eligibility checks; consent and participant withdrawal; randomisation; fidelity of intervention; retention; data quality and analysis; spamming; cybersquatting; PPI; and risk management), along with our own experiences and recommendations based on the development of the REACT randomised controlled trial for relatives of people with psychosis or bipolar disorder. The development considerations and solutions outlined here are relevant for future online and hybrid trials, and Accelerated Creation-to-Sustainment (ACTS) studies, both within general health research and specifically within mental health research for relatives. The structure of what we did is also relevant for future face-to-face trials. Researchers should continue to share lessons learned from conducting online trials of online interventions to benefit future studies.