A randomised controlled trial of dietary improvement for adults with major depression (the ‘SMILES’ trial)

BMC Medicine

Research Article

Allison M. Hodge¹  Cathrine Mihalopoulos²  Mary Lou Chatterton²  David Castle³  Mohammedreza Mohebbi⁴  Felice N. Jacka⁵  Olivia M. Dean⁶  Sarah Dash⁷  Michael Berk⁸  Adrienne O’Neil⁹  Sue Cotton^1,10  Catherine Itsiopoulos^1,11  Laima Brazionis^1,12  Rachelle Opie^1,13 

[1] Cancer Epidemiology and Intelligence Division, Cancer Council Victoria, Carlton, VIC, Australia;Centre for Population Health Research, Deakin University, Geelong, VIC, Australia;Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia;St Vincents Hospital, Fitzroy, VIC, Australia;IMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia;IMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia;Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia;Centre for Adolescent Health, Murdoch Childrens Research Institute, Melbourne, VIC, Australia;Black Dog Institute, Randwick, NSW, Australia;Food & Mood Centre, Deakin University, IMPACT SRC, School of Medicine, PO Box 281, 3220, Geelong, Victoria, Australia;IMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia;Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia;The Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia;Food & Mood Centre, Deakin University, IMPACT SRC, School of Medicine, PO Box 281, 3220, Geelong, Victoria, Australia;IMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia;Food & Mood Centre, Deakin University, IMPACT SRC, School of Medicine, PO Box 281, 3220, Geelong, Victoria, Australia;IMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia;Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, VIC, Australia;The Florey Institute of Neuroscience and Mental Health, Parkville, VIC, Australia;Food & Mood Centre, Deakin University, IMPACT SRC, School of Medicine, PO Box 281, 3220, Geelong, Victoria, Australia;IMPACT Strategic Research Centre, Deakin University, Geelong, VIC, Australia;School of Population Health, The University of Melbourne, Melbourne, VIC, Australia;Food & Mood Centre, Deakin University, IMPACT SRC, School of Medicine, PO Box 281, 3220, Geelong, Victoria, Australia;Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, VIC, Australia;School of Allied Health, La Trobe University, Melbourne, VIC, Australia;School of Allied Health, La Trobe University, Melbourne, VIC, Australia;Department of Medicine, The University of Melbourne, Melbourne, VIC, Australia;School of Allied Health, La Trobe University, Melbourne, VIC, Australia;Food & Mood Centre, Deakin University, IMPACT SRC, School of Medicine, PO Box 281, 3220, Geelong, Victoria, Australia;

关键词: Depression;    Major depressive disorder;    Diet;    Nutrition;    Randomised controlled trial;    Dietetics;   

DOI  :  10.1186/s12916-017-0791-y

 received in 2016-08-31, accepted in 2017-01-11,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe possible therapeutic impact of dietary changes on existing mental illness is largely unknown. Using a randomised controlled trial design, we aimed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes.Methods‘SMILES’ was a 12-week, parallel-group, single blind, randomised controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression. The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician. The control condition comprised a social support protocol to the same visit schedule and length. Depression symptomatology was the primary endpoint, assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) at 12 weeks. Secondary outcomes included remission and change of symptoms, mood and anxiety. Analyses utilised a likelihood-based mixed-effects model repeated measures (MMRM) approach. The robustness of estimates was investigated through sensitivity analyses.ResultsWe assessed 166 individuals for eligibility, of whom 67 were enrolled (diet intervention, n = 33; control, n = 34). Of these, 55 were utilising some form of therapy: 21 were using psychotherapy and pharmacotherapy combined; 9 were using exclusively psychotherapy; and 25 were using only pharmacotherapy. There were 31 in the diet support group and 25 in the social support control group who had complete data at 12 weeks. The dietary support group demonstrated significantly greater improvement between baseline and 12 weeks on the MADRS than the social support control group, t(60.7) = 4.38, p < 0.001, Cohen’s d = –1.16. Remission, defined as a MADRS score <10, was achieved for 32.3% (n = 10) and 8.0% (n = 2) of the intervention and control groups, respectively (χ2 (1) = 4.84, p = 0.028); number needed to treat (NNT) based on remission scores was 4.1 (95% CI of NNT 2.3–27.8). A sensitivity analysis, testing departures from the missing at random (MAR) assumption for dropouts, indicated that the impact of the intervention was robust to violations of MAR assumptions.ConclusionsThese results indicate that dietary improvement may provide an efficacious and accessible treatment strategy for the management of this highly prevalent mental disorder, the benefits of which could extend to the management of common co-morbidities.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820. Registered on 29 February 2012.

【 授权许可】

CC BY   
© The Author(s). 2017