title: A randomised, controlled trial of a dietary intervention for adults with major depression (the "SMILES" trial): study protocol.
abstract: BACKGROUND
  Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE).
  
  
  METHODS
  One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6- months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention.
  
  
  CONCLUSIONS
  If efficacious, this program could provide an alternative or adjunct treatment strategy for the management of this highly prevalent mental disorder; the benefits of which could extend to the management of common co-morbidities including cardiovascular disease (CVD), obesity, and type 2 diabetes.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820.
authors.affiliation: IMPACT Strategic Research Centre, Deakin University, Deakin, VIC, Australia. AONEIL@barwonhealth.org.au
authors.forename: Adrienne
authors.initials: A
authors.lastname: O'Neil
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
authors.forename: Catherine
authors.initials: C
authors.lastname: Itsiopoulos
authors.forename: David
authors.initials: D
authors.lastname: Castle
authors.forename: Rachelle
authors.initials: R
authors.lastname: Opie
authors.forename: Josephine
authors.initials: J
authors.lastname: Pizzinga
authors.forename: Laima
authors.initials: L
authors.lastname: Brazionis
authors.forename: Allison
authors.initials: A
authors.lastname: Hodge
authors.forename: Cathrine
authors.initials: C
authors.lastname: Mihalopoulos
authors.forename: Mary Lou
authors.initials: ML
authors.lastname: Chatterton
authors.forename: Olivia M
authors.initials: OM
authors.lastname: Dean
authors.forename: Felice N
authors.initials: FN
authors.lastname: Jacka
mesh_terms: D000328:Adult; D001315:Australia; D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000178:diet therapy* / Q000523:psychology; D038441:Diet, Mediterranean; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D009520:New Zealand; D012107:Research Design; D012944:Social Support