Developing methods for understanding mechanism in complex interventions

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The general public is exposed through the media to countless claims concerning the efficacy of complex interventions such as psychological therapies for the treatment of depression or other mental health and personal problems. Health service providers are under increasing pressure to increase the availability of interventions such as counselling and psychotherapy. There is clearly a need to design and implement controlled clinical trials to test whether such interventions work. It is equally clear that research projects need to be carried out that can inform on how the interventions work. Understanding the mechanism by which treatments affect clinical outcomes can help to develop new or improve existing treatments. For example if a treatment has a positive effect on a clinical outcome that is not due to changes in the processes targeted then the mechanism by which this beneficial effect arises can potentially be identified and the therapeutical component driving it enhanced. Similarly if a pathway is identified by which a treatment impacts negatively on a clinical outcome then steps might be undertaken to prevent it. The proposed research will develop robust and efficient statistical methods for evaluating the mechanisms by which complex interventions operate. It will also help researchers plan trials so that they can establish not only whether but also how treatments work.