Advancing the quality and safety of behavioural interventions in mental health research: A how-to guide from the MAGNET Clinical Trial Network.

This is the first in a series of Position Papers from the Mental Health Australia General Clinical Trials Network (MAGNET) intended to promote the standard of mental health research in Australia. This paper focuses on improving the quality and safety of non-pharmacological trials with a mental health focus, which for the purpose of this paper, are those testing 'complex' behavioural interventions (including lifestyle or psychotherapy interventions) with clinical populations. This is timely after last year's update of the National Statement for Ethical Conduct in Human Research which is intended to provide extended guidance on assessing, mitigating and managing risk and the introduction of the Australian Commission on Safety & Quality in Healthcare's National Clinical Trials Governance Framework. However, what the implementation of these research policies means for behavioural trials in mental health, given their many nuances, is only being realised. This paper outlines historical issues in the conduct of behavioural trials in mental health (lack of consensus on the concept of harm; lack of governance and inconsistent data collection and/or trial procedures around harms). Next, we detail the methods for developing recommendations to aid triallists' monitoring and assessing safety during the conduct of behavioural mental health trials that evaluate lifestyle or psychotherapy interventions in clinical populations. Finally, we present a decision-making algorithm to support implementation. Ultimately, we intend to promote quality and safety of behavioural interventions in mental health, to better understand the risk/benefit profile of these treatments and to minimise unnecessary risk to participants and triallists.