![]() 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. There were 31 in the diet support group and 25 in the social support control group who had complete data at 12 weeks. 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. We assessed 166 individuals for eligibility, of whom 67 were enrolled (diet intervention, n = 33 control, n = 34). ![]() The robustness of estimates was investigated through sensitivity analyses. Analyses utilised a likelihood-based mixed-effects model repeated measures (MMRM) approach. ![]() Secondary outcomes included remission and change of symptoms, mood and anxiety. Depression symptomatology was the primary endpoint, assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) at 12 weeks. The control condition comprised a social support protocol to the same visit schedule and length. The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician. ‘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. Using a randomised controlled trial design, we aimed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes. The possible therapeutic impact of dietary changes on existing mental illness is largely unknown. ![]()
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