Assessing Cognitive Therapy Instead Of Neuroleptics: Rationale, study design and sample characteristics of the ACTION trial

Abstract

Aims: Recent evidence regarding over-estimation of the efficacy of antipsychotics and under-estimation of their toxicity, as well as emerging data regarding alternative treatment options, suggest it may be time to introduce patient choice. However, only a small number of studies have reported on the efficacy of interventions for psychological interventions such as cognitive therapy. Early results suggest that cognitive therapy may be an effective, well-tolerated treatment for people who choose not to take antipsychotics. We report on the rationale and design for a multi-site randomised, controlled trial of cognitive therapy for people with a schizophrenia spectrum diagnosis who choose not to take antipsychotics.

Methods: The study employs a single-blind design in which all participants receive treatment as usual, and half are randomised to up to 30 sessions of cognitive therapy for up to 9 months. Participants will be followed-up for a minimum of 9 months and to a maximum of 18 months.

Results: We report the characteristics of the final sample at baseline (N = 74).

Conclusions: Our study aims to expand the currently limited evidence base for best practice in interventions for individuals with psychosis who choose not to take antipsychotics.

Acknowledgements

This article outlines independent research commissioned by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Programme. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The authors would like to thank the Mental Health Research Network for their support. We would also like to acknowledge our Service User Reference Group for their work on this study. Some of the arguments outlined in the introduction were first published in an editorial: Morrison, A. P., Hutton, P., Shiers, D., & Turkington, D. (2012) Antipsychotics: is it time to introduce patient choice? The British Journal of Psychiatry, 201, 83–84.