title: Hygienic-dietary recommendations for major depression treatment: study protocol of a randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN73931675.
authors.affiliation: 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
authors.forename: Mauro
authors.initials: M
authors.lastname: Garcia-Toro
authors.forename: Miquel
authors.initials: M
authors.lastname: Roca
authors.forename: Saray
authors.initials: S
authors.lastname: Monzón
authors.forename: Margalida
authors.initials: M
authors.lastname: Vives
authors.forename: Bárbara
authors.initials: B
authors.lastname: Oliván
authors.forename: Enric
authors.initials: E
authors.lastname: Vicens
authors.forename: Joan
authors.initials: J
authors.lastname: Salva
authors.forename: Margalida
authors.initials: M
authors.lastname: Gili
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002985:Clinical Protocols / Q000592:standards; D003865:Major Depressive Disorder / Q000178:diet therapy / Q000628:therapy*; D004032:Diet / Q000379:methods*; D005081:Exercise Therapy / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012890:Sleep / Q000502:physiology; D013472:Sunlight; D016896:Treatment Outcome; D055815:Young Adult