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Open Access Study protocol

Hygienic-dietary recommendations for major depression treatment: Study protocol of a randomized controlled trial

Mauro Garcia-Toro1*, Miquel Roca1, Saray Monzón1, Margalida Vives1, Bárbara Oliván2, Enric Vicens3, Joan Salva14 and Margalida Gili1

Author affiliations

1 Institut Universitari d’Investigació en Ciències de la Salut (IUNICS). Universitat de les Illes Balears (UIB). Red de Investigación en Actividades Preventivas y Promoción de la Salud (redIAPP), Palma de Mallorca, Spain

2 Facultad de Ciencias de la Salud, Universidad de San Jorge, Red de Investigación en Actividades Preventivas y Promoción de la Salud (redIAPP), Zaragoza, Spain

3 Departamento de Psiquiatría, Parc Sanitari San Joan de Déu, Red de Investigación en Actividades Preventivas y Promoción de la Salud (redIAPP), Barcelona, Spain

4 Departamento de Psiquiatría, Hospital Son Espases, Palma de Mallorca, Spain

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Citation and License

BMC Psychiatry 2012, 12:201  doi:10.1186/1471-244X-12-201

Published: 16 November 2012

Abstract

Background

Depression is a highly prevalent and disabling mental disorder with an incidence rate which appears to be increasing in the developed world. This fact seems to be at least partially related to lifestyle factors. Some hygienic-dietary measures have shown their efficacy as a coadjuvant of standard treatment. However, their effectiveness has not yet been proved enough in usual clinical practice.

Methods

Multicenter, randomized, controlled, two arm-parallel, clinical trial involving 300 patients over 18 years old with a diagnosis of Major Depression. Major depression will be diagnosed by means of the Mini-International Neuropsychiatric Interview. The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome. Quality of Life and Social and Health Care Services Consumption Scales will be also administered. Patients will be assessed at three different occasions: baseline, 6-month follow-up and 12-month follow-up.

Discussion

We expect the patients in the active lifestyle recommendations group to experience a greater improvement in their depressive symptoms and quality of life with lower socio-sanitary costs.

Trial registration

ISRCTN73931675

Keywords:
Depression; Hygienic-dietary treatment; Lifestyle recommendations