This project comprises pilot work to provide preliminary ‘proof of principle’ evidence to support a planned programme of research on the methodology of placebo-controlled clinical trials, evaluating the use of placebos from psychological and ethical perspectives.
This project comprises pilot work to provide preliminary ‘proof of principle’ evidence to support a planned programme of research on the methodology of placebo-controlled clinical trials, evaluating the use of placebos from psychological and ethical perspectives. We have identified problems with the ways in which clinical trial participants are told about placebos, both before trials commence and after they have finished. Volunteers for trials are typically given incomplete and at times misleading information about placebos (Bishop et al 2012, PLoS One). Trial participants want to be told when they have been taking placebos and this information needs to be provided sensitively to avoid distress (Bishop et al 2012, Qual Health Research). This project will begin to develop new ways of (a) informing potential trial participants about placebos before they consent to take part in a trial. We are developing new written materials to inform potential clinical trial participants about placebos and placebo effects. The primary aim is to establish whether it is possible to provide accurate, comprehensive, and accessible written information about placebo effects. The secondary aim is to identify whether better elaborated descriptions of placebo effects on information leaflets could actually produce augmented placebo effects. In this pilot work we are testing these effects in a healthy volunteer population. In future we will extend this work into clinical populations.
Funding: University of Southampton Faculty of Social, Human and Mathematical Sciences Strategic Interdisciplinary Research Development Fund (£3500)