Even though this study protocol is dated 2013, it’s worth a mention now because the International Society for Nutritional Psychiatry Research just posted this on the ISNPR facebook page.
Recruitment for this important ‘world first’ trial is finally complete (it is hoped that results will be published in late 2015/early 2016)
It’s very exciting! And don’t you just love the name: the “SMILES” trial!
Adrienne O’Neil, Michael Berk, Catherine Itsiopoulos, David Castle, Rachelle Opie, Josephine Pizzinga, Laima Brazionis, Allison Hodge, Cathrine Mihalopoulos, Mary Lou Chatterton, Olivia M Dean and Felice N Jacka.
BMC Psychiatry 2013, 13:114 doi:10.1186/1471-244X-13-114
The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1471-244X/13/114
© 2013 O’Neil et al.; licensee BioMed Central Ltd.
Abstract
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–Asberg 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.
Although the abstract doesn’t mention anxiety, when you read the full study protocol you’ll see these secondary outcomes and aims too:
Secondary outcomes include; depressive and anxiety symptoms, functioning, quality of life, and changes in targeted dietary behaviours, cardiovascular and metabolic risk. A secondary aim is to evaluate the cost efficacy of the intervention from a societal perspective at 3 months.
When I posted this on Facebook, here is a very positive comment I received:
Quote from the article: “A dietary intervention for depression as an adjunct to standard care, has the potential to be cost-effective, highly acceptable and widely applicable. This approach may lead to improved outcomes for individuals with MDE and reduce the public health burden of psychiatric illness.” This is very encouraging, from someone who has suffered from depression my entire life. I’ve had to be my own advocate, especially with the diet connection and finding a way to stay off medications with difficult side effects. Thanks for sharing!
Someone else made a comment about the amount of protein in the study:
17% protein in the study?
This was my response:
Yes it is rather low and the study includes low fat dairy and whole grains too – but it’s a start – it’s a wonderful start!
We can hope that the next step after this one has been published is to do more like this and hopefully have them include more protein (and discuss the quality of the protein), include more full fat dairy and exclude gluten and even one that excludes all grains.
The long term goal will be to dietary interventions as part of the standard of treatment for anxiety, depression and other mental health disorders.
Dr. Felice Jacka talked about this study and the long term goals during our interview on season 1 of the Anxiety Summit: The Research – Food to prevent and treat anxiety and depression?
This is beyond exciting and we so appreciate the researchers and study participants!
How excited are you to see this research being done?