401. Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with Depression: Study protocol of a randomized controlled trial
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Margalida Vives, Olga Ibarra, Margalida Gili, Joan Salva, Saray Monzón, Mauro García-Toro, Javier García-Campayo, Miquel Roca, and Maria J. Serrano
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Research design ,Adult ,Male ,sueño ,medicine.medical_specialty ,Mediterranean diet ,humanos ,ejercicio físico ,Diet, Mediterranean ,law.invention ,Study Protocol ,Randomized controlled trial ,Clinical Protocols ,trastorno depresivo ,law ,Epidemiology ,Medicine ,Humans ,Exercise ,luz solar ,Depression (differential diagnoses) ,Depressive Disorder ,protocolos clínicos ,dieta ,business.industry ,lcsh:Public aspects of medicine ,Public Health, Environmental and Occupational Health ,lcsh:RA1-1270 ,adulto ,tratamiento combinado ,medicine.disease ,Combined Modality Therapy ,Diet ,Research Design ,Physical therapy ,Sunlight ,Major depressive disorder ,Antidepressant ,Female ,Biostatistics ,business ,Sleep ,diseño de la investigación - Abstract
Background: In recent years some studies have been published supporting the efficacy of light exposure, physical activity, sleep control and a Mediterranean diet pattern on the improvement or prevention of Depression. However, to our knowledge, there have been no studies using all these measures together as an adjuvant antidepressant strategy. Methods: Multicenter, randomized, controlled, two arm-parallel, clinical trial. Eighty depressed patients undergoing standard antidepressant treatment will be advised to follow four additional hygienic-dietary recommendations about exercise, diet, sunlight exposure and sleep. Outcome measures will be assessed before and after the 6 month intervention period. Discussion: We expect the patients in the active recommendations group to experience a greater improvement in their depressive symptoms. If so, this would be a great support for doctors who might systematically recommend these simple and costless measures, especially in primary care., We wish to thank the Instituto de Salud Carlos III of the Spanish Ministry of Health for funding the study (FIS no PI07 0544). We also thank Charles O'Brien's help in translating the manuscript.
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