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Nutritional counselling in adults promoting adherence to the Mediterranean diet as adjuvant in the treatment of major depressive disorder (INDEPT): a randomized open controlled trial study protocol

2023-04-04Journal article Open access
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dc.contributor.authorSousa-Santos, Nuno
dc.contributor.authorFialho, Mónica
dc.contributor.authorMadeira, Teresa
dc.contributor.authorClara, Cátia
dc.contributor.authorVeiga, Sofia
dc.contributor.authorMartins, Raquel
dc.contributor.authorBarros, Neuza
dc.contributor.authorSantos, Gabriela
dc.contributor.authorSantos, Osvaldo
dc.contributor.authorAlmeida, Carolina
dc.contributor.authorGanança, Licínia
dc.contributor.authorCampos, Rui C.
dc.contributor.authorCamolas, José
dc.contributor.authorda Silva, Alda Pereira
dc.contributor.authorGuarino, Maria Pedro Sucena
dc.contributor.authorHeitor, Maria João
dc.date.accessioned2024-01-05T14:34:52Z
dc.date.available2024-01-05T14:34:52Z
dc.date.issued2023-04-04
dc.descriptionFunding This study is funded by Portuguese national funds provided by Fundação para a Ciência e Tecnologia (FCT) UI/05704/2020, PTDC/SAU-NUT/3321/2020, and FCT202008719BD. MPG was funded by CEECINST/00051/2018. The study sponsor and funder of this trial are not directly involved in any of the following procedures: study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. The ultimate authority over any of these activities is the responsibility of the responsible investigator for the project (PhD Maria João Heitor).pt_PT
dc.description.abstractBackground Major Depressive Disorder (MDD) is a leading cause of disability worldwide. Approximately one-third of patients with MDD do not respond to treatment, and often exhibit elevated inflammation biomarkers, which are associated with worse prognosis. Previous research has linked healthier dietary patterns, such as the Mediterranean Diet (MedDiet), with a lower risk of MDD and symptoms of depression, potentially due to their anti-inflammatory properties. The aim of this study is to evaluate the effectiveness of a nutritional counselling intervention promoting MedDiet to alleviate symptoms of depression in adults recently diagnosed with MDD and presenting with elevated inflammation biomarkers. Methods This study is a randomized controlled trial (RCT) that will recruit adults from outpatient clinics, between the ages of 18 and 70 years who have been diagnosed with MDD and are currently receiving treatment with the first prescribed antidepressant, and who exhibit elevated inflammation biomarkers (interleukin-6 and/or C-reactive protein). The control group will receive treatment-as-usual (TAU) only. The primary outcome of the study will be the change in symptoms of depression, as measured by the Beck Depression Inventory 2 (BDI-II), after 12 weeks of intervention. Data analysis will follow an intention-to-treat approach. Secondary outcomes will include changes in inflammation biomarkers, quality of life, adherence to the MedDiet, and cost-effectiveness of nutritional counselling. All outcomes will be assessed at baseline, after the 12-week intervention, and at 6- and 12-months post-baseline. Discussion This study will be the first RCT to evaluate the effect of a nutritional intervention with anti-inflammatory properties, as an adjuvant in the treatment of MDD, in individuals diagnosed with MDD and elevated inflammation biomarkers. The results of this study may contribute to the development of more effective and personalized interventions for MDD patients with elevated inflammation biomarkers.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationSousa-Santos, N., Fialho, M., Madeira, T. et al. Nutritional counselling in adults promoting adherence to the Mediterranean diet as adjuvant in the treatment of major depressive disorder (INDEPT): a randomized open controlled trial study protocol. BMC Psychiatry 23, 227 (2023). https://doi.org/10.1186/s12888-023-04705-zpt_PT
dc.identifier.doihttps://doi.org/10.1186/s12888-023-04705-zpt_PT
dc.identifier.eissn1471-244X
dc.identifier.urihttp://hdl.handle.net/10400.8/9176
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBMCpt_PT
dc.relationA Randomized Controlled Trial to evaluate the effects of the Mediterranean Diet as an adjuvant in the treatment of Major Depressive Disorder
dc.relationNot Available
dc.relation.ispartofseries227;
dc.relation.publisherversionhttps://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04705-zpt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectRandomized Controlled Trialpt_PT
dc.subjectMajor depressive disorderpt_PT
dc.subjectDepressionpt_PT
dc.subjectMediterranean Dietpt_PT
dc.subjectInflammationpt_PT
dc.titleNutritional counselling in adults promoting adherence to the Mediterranean diet as adjuvant in the treatment of major depressive disorder (INDEPT): a randomized open controlled trial study protocolpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.awardTitleA Randomized Controlled Trial to evaluate the effects of the Mediterranean Diet as an adjuvant in the treatment of Major Depressive Disorder
oaire.awardTitleNot Available
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/3599-PPCDT/PTDC%2FSAU-NUT%2F3321%2F2020/PT
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/CEEC INST 2018/CEECINST%2F00051%2F2018%2FCP1566%2FCT0001/PT
oaire.citation.endPage11pt_PT
oaire.citation.startPage1pt_PT
oaire.citation.titleBMC Psychiatrypt_PT
oaire.citation.volume23pt_PT
oaire.fundingStream3599-PPCDT
oaire.fundingStreamCEEC INST 2018
person.familyNameSousa Santos
person.familyNamedos Reis Clara
person.familyNameGuarino
person.givenNameNuno
person.givenNameCátia Andreia
person.givenNameMaria Pedro
person.identifier.ciencia-id8F17-95D6-AE7E
person.identifier.ciencia-id341F-C3EC-A746
person.identifier.ciencia-idF21A-BD01-2D52
person.identifier.orcid0000-0002-8979-8551
person.identifier.orcid0000-0002-9813-3412
person.identifier.orcid0000-0001-6079-1105
person.identifier.ridB-5594-2015
person.identifier.scopus-author-id57202154870
person.identifier.scopus-author-id56348477000
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.nameFundação para a Ciência e a Tecnologia
project.funder.nameFundação para a Ciência e a Tecnologia
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
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