I recently attended the full to capacity Northumberland Tyne and Wear (NTW) NHS Trust Research and Development (R&D) Day, which celebrates research successes in the trust every year. I was attending the event with one of my NIHR Research Design Service North East colleagues to offer pre-bookable appointments and drop-in sessions for those who wanted advice and support to develop grant applications for national peer reviewed funders. The NIHR Research Design Service (RDS) can help health and social care researchers to turn small ideas into successful funding applications. Once the team have the funding they can turn that small acorn of an idea into a mighty oak research project of the type that can be celebrated at an R&D day!
One study from the day that stood out for me for taking an idea, achieving a relatively small pot of funding, and doing big things with it was research presented by Rob Dudley. Rob was a member of a team led by Prof Anthony Morrison of University of Manchester that had achieved NIHR RfPB funding for a pilot project to look at cognitive therapy for individuals with schizophrenia spectrum disorders who were not taking antipsychotic medication. This is usually the first line treatment but patients may stop, or not start, taking medication for a variety of reasons. This study used a randomised controlled trial methodology, with participants randomly allocated to the treatment group where they received cognitive therapy on top of their usual care or to the control group where they received only usual care. The team met with success in 2014 publishing their study in the Lancet.
The study has received some criticism, however, such as this review on The Mental Elf blog. Concerns were raised about the lack of inclusion of an ‘active’ control group (e.g., a befriending service where participants would receive the same kind of care and attention as those in the treatment group), as there is an argument that improvements in symptoms across a range of mental health disorders may be as a consequence of having a supportive person to talk to rather than the content of the therapy per se. The inclusion of an active control would be important in a definitive trial aiming to establish the effectiveness of the treatment. This paper was a pilot study to inform a larger trial – the focus of this initial study being more on the safety and acceptability of this treatment for this population, and therefore an active control was less important.
Further criticisms have also been raised that patients in the study were not blind to which group they were in and this may have affected their self-reported symptoms. In a drug trial participants can be blind to whether they are in the treatment group of the control group as it is possible to create a placebo drug that looks identical to the treatment drug, but contains none of the active ingredients. It is much more difficult to ‘blind’ participants in this way when the treatment is behavioural or cognitive in nature. Alongside this in many drug trials the outcome is often more objective, for example the level of a hormone in the body. In studies which include cognitive or behavioural treatments the outcomes often involve the patient being asked to report on the symptoms which they are experiencing. These outcomes are more subjective, meaning that they can be influenced by a desire to ‘give the right answer’, or by placebo effects – with this being a greater concern if respondents are not blind to which group they are in and believe one of the treatments is more likely to work than the other. The authors of this study tried to address this issue by having outcome assessments made by blind raters, who were unaware of which group the participant had been allocated to, and therefore did not know whether they had received cognitive therapy or not.
This research arose from a small pot of funding and has certainly attracted a lot of attention. Hopefully a lot of the people who we spoke to at the R&D day will have been inspired by the passion of the researchers who presented and will want to go on to achieve funding and have their own successes. Maybe at NIHR Research Design Service North East we will get to hear presentations from them at the same event in a few years’ time. If you would like advice on designing your own research project please contact your local NIHR Research Design Service.