The randomised controlled trial, though highly valued, has been criticised as not helping to understand how results occur: Real-life complexity is not captured, i.e. what actually happens at trial sites (rather than what was intended). The purpose of this paper is to summarise and comment on two 2014 research papers addressing this challenge of randomised trials – concerning new therapeutic approaches for people diagnosed with psychotic disorders.
One paper is about what staff thought when adopting a new recovery-focused approach in two mental health services as part of a randomised trial. The other is the plan for a small pilot trial of a new treatment for psychosis called positive psychotherapy. It describes how the researchers planned to study the detail of what happens in their small trial, to help them improve the design of a future, larger trial.
The first paper recommends avoiding services undergoing too many changes and ensuring managers will visibly support the project. When training staff in a new approach, trainers should recognise staff's existing knowledge and skills and use practical methods like role-play. In the second paper, the plan for the small positive psychotherapy trial seems detailed enough to explain what really happens, except in one area: looking at how clinicians actually select service users for the trial.
These papers concern pioneering therapeutic approaches in psychosis. With randomised trials highly influential, both these papers recognise their potential problems, and seem to represent good attempts to understand what really happens.
Emerald Group Publishing Limited
Copyright © 2014, Emerald Group Publishing Limited