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

Jacka, Felice N., O'Neil, Adrienne, Opie, Rachelle, Itsiopoulos, Catherine, Cotton, Sue, Mohebbi, Mohammedreza, Castle, David, Dash, Sarah, Mihalopoulos, Cathrine, Chatterton, Mary Lou, Brazionis, Laima, Dean, Olivia M., Hodge, Allison M. and Berk, Michael 2017, A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial), BMC medicine, vol. 15, no. 1, pp. 1-13, doi: 10.1186/s12916-017-0791-y.

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Title A randomised controlled trial of dietary improvement for adults with major depression (the 'SMILES' trial)
Author(s) Jacka, Felice N.
O'Neil, Adrienne
Opie, Rachelle
Itsiopoulos, Catherine
Cotton, Sue
Mohebbi, Mohammedreza
Castle, David
Dash, Sarah
Mihalopoulos, Cathrine
Chatterton, Mary Lou
Brazionis, Laima
Dean, Olivia M.
Hodge, Allison M.
Berk, Michael
Journal name BMC medicine
Volume number 15
Issue number 1
Article ID 23
Start page 1
End page 13
Total pages 13
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2017-01-30
ISSN 1741-7015
Keyword(s) depression
diet
dietetics
major depressive disorder
nutrition
randomised controlled trial
Summary BACKGROUND: The 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. RESULTS: We 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 (χ (2) (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. CONCLUSIONS: These 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 REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820 . Registered on 29 February 2012.
Language eng
DOI 10.1186/s12916-017-0791-y
Field of Research 111714 Mental Health
140208 Health Economics
11 Medical And Health Sciences
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2017, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30091141

Document type: Journal Article
Collections: Population Health
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.