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Randomized Controlled Trial
. 2018 May 22;18(1):599.
doi: 10.1186/s12889-018-5504-8.

Economic evaluation of a dietary intervention for adults with major depression (the "SMILES" trial)

Mary Lou Chatterton  1 , Cathrine Mihalopoulos  2 , Adrienne O'Neil  3 , Catherine Itsiopoulos  4 , Rachelle Opie  4 , David Castle  5 , Sarah Dash  6 , Laima Brazionis  7 , Michael Berk  6   8 , Felice Jacka  6   9   10
Affiliations
Randomized Controlled Trial

Economic evaluation of a dietary intervention for adults with major depression (the "SMILES" trial)

Mary Lou Chatterton et al. BMC Public Health. .

Abstract

Background: Recently, the efficacy of dietary improvement as a therapeutic intervention for moderate to severe depression was evaluated in a randomised controlled trial. The SMILES trial demonstrated a significant improvement in Montgomery-Åsberg Depression Rating Scale scores favouring the dietary support group compared with a control group over 12 weeks. We used data collected within the trial to evaluate the cost-effectiveness of this novel intervention.

Methods: In this prospective economic evaluation, sixty-seven adults meeting DSM-IV criteria for a major depressive episode and reporting poor dietary quality were randomised to either seven sessions with a dietitian for dietary support or to an intensity matched social support (befriending) control condition. The primary outcome was Quality Adjusted Life Years (QALYs) as measured by the AQoL-8D, completed at baseline and 12 week follow-up (endpoint) assessment. Costs were evaluated from health sector and societal perspectives. The time required for intervention delivery was costed using hourly wage rates applied to the time in counselling sessions. Food and travel costs were also included in the societal perspective. Data on medications, medical services, workplace absenteeism and presenteesim (paid and unpaid) were collected from study participants using a resource-use questionnaire. Standard Australian unit costs for 2013/2014 were applied. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in average costs between groups divided by the difference in average QALYs. Confidence intervals were calculated using a non-parametric bootstrap procedure.

Results: Compared with the social support condition, average total health sector costs were $856 lower (95% CI -1247 to - 160) and average societal costs were $2591 lower (95% CI -3591 to - 198) for those receiving dietary support. These differences were driven by lower costs arising from fewer allied and other health professional visits and lower costs of unpaid productivity. Significant differences in mean QALYs were not found between groups. However, 68 and 69% of bootstrap iterations showed the dietary support intervention was dominant (additional QALYs at less cost) from the health sector and societal perspectives.

Conclusions: This novel dietary support intervention was found to be likely cost-effective as an adjunctive treatment for depression from both health sector and societal perspectives.

Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820 . Registered on 29 February 2012.

Keywords: Depression; Diet; Economic evaluation; Major depressive disorder; Nutrition; Randomised controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from St. Vincent’s Hospital, Barwon Health and Deakin University Human Research Ethics Committees. All participants provided written informed consent after receiving a full description of the study.

Competing interests

Mary Lou Chatterton has received funding support from the NHMRC, Beyond Blue, Barwon Child Youth & Family, and Medibank Private Health Research Fund. She has served as a consultant for Astra Zeneca, Biogen, and Genentech.

Cathrine Mihalopoulos was supported by an NHMRC Early Career Development Fellowship (#1035887) at the time of this work. She has also received additional funding support from the NHMRC, Cancer Council, Mental Illness Research Fund, Medibank Private Health Research Fund, Macquarie University, Beyond Blue, Murdoch Children’s Research Institute, The University of Melbourne, The Australian Commonwealth Department of Health and Ageing, and the Australian National Mental Health Commission.

Adrienne O’Neil has received funding from Meat and Livestock Australia and is supported by an NHMRC ECR Fellowship (#1052865).

Catherine Itsiopoulos has received funding from the NHMRC, the University of Melbourne, 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 and SWISSE Wellness P/L. She has received speaker honoraria from Astra Zeneca, Boehringer Ingelheim and Dairy Australia.

David Castle has received grant monies for research from Eli Lilly, Janssen Cilag, Roche, Allergen, Bristol-Myers Squibb, Pfizer, Lundbeck, Astra Zeneca and Hospira and travel support and honoraria for talks and consultancy from Eli Lilly, Bristol-Myers Squibb, Astra Zeneca, Lundbeck, Janssen Cilag, Pfizer, Organon, Sanofi-Aventis, Wyeth, Hospira and Servier. He is a current Advisory Board Member for Lu AA21004; Lundbeck; Varenicline: Pfizer; Asenapine: Lundbeck; Aripiprazole LAI: Lundbeck; Lisdexamfetamine: Shire; Lurasidone: Servier. He has no stocks or shares in any pharmaceutical company.

Michael Berk has received Grant/Research Support from the NIH, Cooperative Research Centre, Simons Autism Foundation, Cancer Council of Victoria, Stanley Medical Research Foundation, MBF, NHMRC, Beyond Blue, Rotary Health, Geelong Medical Research Foundation, Bristol Myers Squibb, Eli Lilly, Glaxo SmithKline, Meat and Livestock Board, Organon, Novartis, Mayne Pharma, Servier and Woolworths. He has been a speaker for Astra Zeneca, Bristol Myers Squibb, Eli Lilly, Glaxo SmithKline, Janssen Cilag, Lundbeck, Merck, Pfizer, Sanofi Synthelabo, Servier, Solvay and Wyeth, and served as a consultant to Allergan, Astra Zeneca, Bioadvantex, Bionomics, Collaborative Medicinal Development, Eli Lilly, Glaxo SmithKline, Janssen Cilag, Lundbeck Merck, Pfizer and Servier. He is supported by an NHMRC Senior Principal Research Fellowship (#1059660).

Felice N Jacka has received Grant/Research support from the Brain and Behaviour Research Institute, the NHMRC, Australian Rotary Health, the Geelong Medical Research Foundation, the Ian Potter Foundation, Eli Lilly, Meat and Livestock Australia, Woolworths Limited and The University of Melbourne and has received speakers honoraria from Sanofi-Synthelabo, Janssen Cilag, Servier, Pfizer, Health Ed, Network Nutrition, Angelini Farmaceutica, Metagenics and Eli Lilly. She is supported by an NHMRC Career Development Fellowship (#1108125).

The other authors have no relevant financial disclosures to declare.

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Figures

Fig. 1
Fig. 1
Cost-effectiveness planes. a Health sector costs; ITT. b Societal costs; ITT
See this image and copyright information in PMC

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