期刊
BMC MEDICINE
卷 15, 期 -, 页码 -出版社
BMC
DOI: 10.1186/s12916-017-0791-y
关键词
Depression; Major depressive disorder; Diet; Nutrition; Randomised controlled trial; Dietetics
资金
- National Health and Medical Research Council of Australia (NHMRC) [1021347]
- Woolworths Limited
- Meat and Livestock Australia
- Brain and Behaviour Research Institute
- National Health and Medical Research Council (NHMRC)
- Australian Rotary Health
- Geelong Medical Research Foundation
- Ian Potter Foundation
- Eli Lilly
- University of Melbourne
- NHMRC Career Development Fellowship [1108125]
- NHMRC ECR Fellowship [1052865]
- NHMRC
- Deakin University
- La Trobe University
- Meat and Livestock Board
- Australian Society for Enteral and Parenteral Nutrition
- Harokopio University in Athens
- Commonwealth Department of Education, Employment and Workplace relations
- Diabetes Australia
- SWISSE Wellness P/L
- NHMRC Early Career Development Fellowship [1035887]
- Cancer Council
- Mental Illness Research Fund
- Medibank Private Health Research Fund
- Macquarie University
- Beyond Blue
- Janssen Cilag
- Roche
- Allergen
- Bristol-Myers Squibb
- Pfizer
- Lundbeck
- Astra Zeneca
- Hospira
- Brain and Behaviour Foundation
- Marion and EH Flack Trust
- Simons Autism Foundation
- Stanley Medical Research Institute
- Australasian Society for Bipolar and Depressive Disorders
- Servier
- BioMedica Nutracuticals
- NutritionCare
- Bioceuticals
- NIH
- Cooperative Research Centre
- Cancer Council of Victoria
- Stanley Medical Research Foundation
- MBF
- Rotary Health
- Bristol Myers Squibb
- Glaxo SmithKline
- Organon
- Novartis
- Mayne Pharma
- Woolworths
- NHMRC Senior Principal Research Fellowship [1059660]
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-angstrom sberg 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 (chi(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.
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