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BMC Med. 2018 Dec 28;16(1):243. doi: 10.1186/s12916-018-1221-5.

The SMILES trial: do undisclosed recruitment practices explain the remarkably large effect?

Author information

1
Institute of Psychology, Clinical Psychology Unit, Leiden University, Leiden, The Netherlands. molendijkml@fsw.leidenuniv.nl.
2
Leiden Institute of Brain and Cognition, Leiden University Medical Center, Leiden, The Netherlands. molendijkml@fsw.leidenuniv.nl.
3
Institute of Psychology, Clinical Psychology Unit, Leiden University, Leiden, The Netherlands.
4
Department of Psychology, University of Amsterdam, Amsterdam, The Netherlands.
5
Leiden Institute of Brain and Cognition, Leiden University Medical Center, Leiden, The Netherlands.
6
Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.

Abstract

The SMILES trial showed substantial improvement of depressive symptoms following seven consultations on healthy dieting. The very large effect size on depression reduction seems remarkable and we suggest that selectively induced expectancy and a loss of blinding have contributed to the observed effect.

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