A randomised, controlled trial of a dietary intervention for adults with major depression (the “SMILES” trial): study protocol

BMC Psychiatry

Felice N Jacka⁷  Olivia M Dean⁷  Mary Lou Chatterton⁶  Cathrine Mihalopoulos⁶  Allison Hodge⁴  Laima Brazionis¹  Josephine Pizzinga⁵  Rachelle Opie³  David Castle⁸  Catherine Itsiopoulos³  Michael Berk⁷  Adrienne O’Neil² 

[1] Department of Medicine, The University of Melbourne, Melbourne, VIC, Australia;School of Public Health and Preventive Medicine, Monash University, Monash, VIC, Australia;Department of Dietetics, Faculty of Health Sciences, Latrobe University, Latrobe, VIC, Australia;Cancer Epidemiology Centre, The Cancer Council Victoria, Melbourne, VIC, Australia;IMPACT Strategic Research Centre, Deakin University, Deakin, VIC, Australia;Population Health Strategic Research Centre, Faculty of Health, Deakin University, Deakin, VIC, Australia;Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia;Department of Psychiatry, St Vincent’s Hospital, Melbourne, VIC, Australia

关键词: Social support;    Mental health;    Depression;    Nutrition;    Diet;   

Others  :  1124080
DOI  :  10.1186/1471-244X-13-114

 received in 2013-04-07, accepted in 2013-04-09,  发布年份 2013

【 摘 要 】

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/Design

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.

Discussion

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.

Trial registration

NCT01523561

【 授权许可】

   
2013 O’Neil et al.; licensee BioMed Central Ltd.

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