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BMC Psychiatry
Published in: BMC Psychiatry 1/2019

Open Access 01-12-2019 | Affective Disorder | Study protocol

Preventing the recurrence of depression with a Mediterranean diet supplemented with extra-virgin olive oil. The PREDI-DEP trial: study protocol

Authors: A. Sánchez-Villegas, B. Cabrera-Suárez, P. Molero, A. González-Pinto, C. Chiclana-Actis, C. Cabrera, F. Lahortiga-Ramos, M. Florido-Rodríguez, P. Vega-Pérez, R. Vega-Pérez, J. Pla, M. J. Calviño-Cabada, F. Ortuño, S. Navarro, Y. Almeida, J. L. Hernández-Fleta

Published in: BMC Psychiatry | Issue 1/2019

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Abstract

Background

The role of dietary patterns in the prevention of unipolar depression has been analyzed in several epidemiological studies. The primary aims of this study are to determine the effectiveness of an extra-olive oil-enriched Mediterranean diet in reducing the recurrence of depression and improving the symptoms of this condition.

Methods

Multicenter, two-arm, parallel-group clinical trial. Arm 1, extra-virgin olive oil Mediterranean diet; Arm 2, control group without nutritional intervention. Dieticians are in charge of the nutritional intervention and regular contact with the participants. Contacts are made through our web platform (https://​predidep.​es/​participantes/​) or by phone. Recurrence of depression is assessed by psychiatrists and clinical psychologists through clinical evaluations (semi-structured clinical interviews: Spanish SCID-I). Depressive symptoms are assessed with the Beck Depression Inventory. Information on quality of life, level of physical activity, dietary habits, and blood, urine and stool samples are collected after the subject has agreed to participate in the study and once a year.

Discussion

To the best of our knowledge, the PREDI-DEP trial is the first ongoing randomized clinical trial designed to assess the role of the Mediterranean diet in the prevention of recurrent depression. It could be a cost-effective approach to avoid recurrence and improve the quality of life of these patients.

Trial registration

The study has been prospectively registered in the U.S. National Library of Medicine (https://​clinicaltrials.​gov) with NCT number: NCT03081065.
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Literature
1.
Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2013;380(9859):2197–23.CrossRef
2.
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211–59.CrossRef
3.
de Jonge M, Bockting CL, Kikkert MJ, Bosmans JE, Dekker JJ. Preventive cognitive therapy versus treatment as usual in preventing recurrence of depression: protocol of a multi-centered randomized controlled trial. BMC Psychiatry. 2015;15:139.CrossRef
4.
Berk M, Sarris J, Coulson CE, Jacka FN. Lifestyle management of unipolar depression. Acta Psychiatr Scand Suppl. 2013;443:38–54.CrossRef
5.
Lopresti AL, Hood SD, Drummond PD. A review of lifestyle factors that contribute to important pathways associated with major depression: diet, sleep and exercise. J Affect Disord. 2013;148(1):12–279.CrossRef
6.
Molendijk M, Molero P, Ortuño Sánchez-Pedreño F, Van der Does W, Angel Martínez-González M. Diet quality and depression risk: a systematic review and dose-response meta-analysis of prospective studies. J Affect Disord. 2018;226:346–54.CrossRef
7.
Martínez-González MA, Sánchez-Villegas A. Food patterns and the prevention of depression. Proc Nutr Soc. 2016;75(2):139–46.CrossRef
8.
Opie RS, Itsiopoulos C, Parletta N, Sánchez-Villegas A, Akbaraly TN, Ruusunen A, et al. Dietary recommendations for the prevention of depression. Nutr Neurosci. 2017;20(3):161–71.CrossRef
9.
Sarris J, Alan C, Logan BA, Akbaraly TN, Amminger GP, Balanzá-Martínez V, et al. Nutritional medicine as mainstream in psychiatry. Lancet Psychiatry. 2015;2(3):271–4.CrossRef
10.
Sánchez-Villegas A, Henríquez-Sánchez P, Ruiz-Canela M, Lahortiga F, Molero P, Toledo E, et al. A longitudinal analysis of diet quality scores and the risk of incident depression in the SUN Project. BMC Med. 2015;13:197.CrossRef
11.
Vermeulen E, Stronks K, Visser M, Brouwer IA, Schene AH, Mocking RJ, et al. The association between dietary patterns derived by reduced rank regression and depressive symptoms over time: the Invecchiare in chianti (InCHIANTI) study. Br J Nutr. 2016;115(12):2145–53.CrossRef
12.
Adjibade M, Assmann KE, Andreeva VA, Lemogne C, Hercberg S, Galan P, et al. Prospective association between adherence to the Mediterranean diet and risk of depressive symptoms in the French SU.VI.MAX cohort. Eur J Nutr. 2008;57(3):1225–35.CrossRef
13.
Parletta N, Zarnowiecki D, Cho J, Wilson A, Bogomolova S, Villani A, et al. A Mediterranean-style dietary intervention supplemented with fish oil improves diet quality and mental health in people with depression: A randomized controlled trial (HELFIMED). Nutr Neurosci. 2017:1–14. https://​doi.​org/​10.​1080/​1028415X.​2017.​1411320. [Epub ahead of print]. In press
14.
Opie RS, O'Neil A, Jacka FN, Pizzinga J, Itsiopoulos C. A modified Mediterranean dietary intervention for adults with major depression: Dietary protocol and feasibility data from the SMILES trial. Nutr Neurosci. 2018;21(7):487–501.
15.
First MB, Spitzer RL, Williams JBW, Gibbon M. Entrevista Clínica Estructurada para los Trastornos del Eje I del DSM-IV, Versión Clínica (SCID-I-VC). Barcelona: Masson; 1999.
16.
Sanz J, Perdigón AL, Vázquez C. Adaptación española del Inventario para la Depresión de Beck-II (BDI-II): 2. Propiedades psicométricas en población general. Clínica y Salud. 2003;1(3):249–80.
17.
Martínez-González MA, Salas-Salvadó J, Estruch R, Corella D, Fitó M, Ros E, et al. Benefits of the Mediterranean diet: insights from the PREDIMED study. Prog Cardiovasc Dis. 2015;58(1):50–60.CrossRef
18.
Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013;368(14):1279–90.CrossRef
19.
Schröder H, Fitó M, Estruch R, Martínez-González MA, Corella D, Salas-Salvadó J, et al. Validation of a short screener for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011;141:1140–5.CrossRef
20.
Fernández-Ballart JD, Pinol JL, Zazpe I, Corella D, Carrasco P, Toledo E, et al. Relative validity of a semi-quantitative food-frequency questionnaire in an elderly Mediterranean population of Spain. Br J Nutr. 2009;103(12):1808–16.CrossRef
21.
Martínez-González MA, López-Fontana C, Varo JJ, Sánchez-Villegas A, Martínez JA. Validation of the Spanish version of the physical activity questionnaire used in the Nurses’ health study and the health Professionals’ follow-up study. Public Health Nutr. 2005;8(7):920–7.CrossRef
22.
Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, et al. El Cuestionario de Salud SF-36 español: una década de experiencia y nuevos desarrollos. Gac Sanit. 2005;19:135–50.CrossRef
23.
Sánchez-Villegas A, Delgado-Rodríguez M, Alonso A, Schlatter J, Lahortiga F, Serra Majem L, et al. Association of the Mediterranean dietary pattern with the incidence of depression: the Seguimiento Universidad de Navarra/University of Navarra follow-up (SUN) cohort. Arch Gen Psychiatry. 2009;66(10):1090–8.CrossRef
24.
Sánchez-Villegas A, Martínez-González MA, Estruch R, Salas-Salvadó J, Corella D, Covas MI, et al. Mediterranean dietary pattern and depression: the PREDIMED randomized trial. BMC Med. 2013;11:208.CrossRef
25.
Porta M, Bonet C, Cobo E. Discordance between reported intention-to-treat and per protocol analyses. J Clin Epidemiol. 2007;60:663–9.CrossRef
26.
Robins JM, Hernán M, Brumback B. Marginal structural models and causal inference in epidemiology. Epidemiology. 2000;11:550–60.CrossRef
27.
Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. Adherence to a Mediterranean diet and survival in a Greek population. N Engl J Med. 2003;348(26):2599–608.CrossRef
28.
Desquilbet L, Mariotti F. Dose-response analyses using restricted cubic spline functions in public health research. Stat Med. 2010;29(9):1037–57.PubMed
29.
Royston P, Sauerbrei W. MFP: multivariable model-building with fractional polynomials. En: Royston P, editor. Multivariable model-building: a pragmatic approach to regression analysis based on fractional polynomials for modelling continuous variables. Chichester: John Wiley & Sons, 2008. pp. 79–96.
30.
Groenwold RH, Donders AR, Roes KC, Harrell FE Jr, Moons KG. Dealing with missing outcome data in randomized trials and observational studies. Am J Epidemiol. 2012;175:210–7.CrossRef
31.
Little RJA, Rubin DB. Statistical Analysis with Missing Data, 2ª ed. Hoboken: J.W. Wiley & Sons; 2002.CrossRef
32.
Roca M, Kohls E, Gili M, Watkins E, Owens M, Hegerl U, et al. Prevention of depression through nutritional strategies in high-risk persons: rationale and design of the MooDFOOD prevention trial. BMC Psychiatry. 2016;16:192.CrossRef
33.
Eaton WW, Shao H, Nestadt G, Lee HB, Bienvenu OJ, Zandi P. Population-based study of first onset and chronicity in major depressive disorder. Arch Gen Psychiatry. 2008;65:513–20.CrossRef
34.
Solomon DA, Keller MB, Leon AC, Mueller TI, Lavori PW, Shea MT, et al. Multiple recurrences of major depressive disorder. Am J Psychiatry. 2000;157:229–33.CrossRef
35.
Nigg CR, Burbank PM, Padula C, Dufresne R, Rossi JS, Velicer WF, et al. Stages of change across ten health risk behaviors for older adults. Gerontologist. 1999;39(4):473–82.CrossRef
Metadata
Title
Preventing the recurrence of depression with a Mediterranean diet supplemented with extra-virgin olive oil. The PREDI-DEP trial: study protocol
Authors
A. Sánchez-Villegas
B. Cabrera-Suárez
P. Molero
A. González-Pinto
C. Chiclana-Actis
C. Cabrera
F. Lahortiga-Ramos
M. Florido-Rodríguez
P. Vega-Pérez
R. Vega-Pérez
J. Pla
M. J. Calviño-Cabada
F. Ortuño
S. Navarro
Y. Almeida
J. L. Hernández-Fleta
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2019
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-019-2036-4

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