Hygienic-dietary recommendations for major depression treatment: study protocol of a randomized controlled trial.
Mauro Garcia-Toro, Miquel Roca, Saray Monzón, Margalida Vives, Bárbara Oliván, Enric Vicens, Joan Salva, Margalida Gili
Author Information
Mauro Garcia-Toro: Institut Universitari d'Investigació en Ciències de la Salut, Universitat de les Illes Balears, Red de Investigación en Actividades Preventivas y Promoción de la Salud, Palma de Mallorca, Spain. mauro.garcia@uib.es
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.
Associated Data
ISRCTN | ISRCTN73931675
References
BMC Psychiatry. 2011 Feb 07;11:20
[PMID: 21294921]
