Evidence map›Paper›PMID 37016319›Full record

ArticleBMC psychiatry2023

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.

Nuno Sousa-Santos, Mónica Fialho, Teresa Madeira, Cátia Clara, Sofia Veiga, Raquel Martins, Neuza Barros, Gabriela Santos, Osvaldo Santos, Carolina Almeida and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Nuno Sousa-SantosCenter for Innovative Care and Health Technology (ciTechcare), Instituto Politécnico, Leiria - R. de Santo André, Leiria, 2410, Portugal. nunoneto@edu.ulisboa.pt.
Mónica FialhoInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
Teresa MadeiraInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
Cátia ClaraCenter for Innovative Care and Health Technology (ciTechcare), Instituto Politécnico, Leiria - R. de Santo André, Leiria, 2410, Portugal.
Sofia VeigaInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
Raquel MartinsInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
Neuza BarrosCenter for Innovative Care and Health Technology (ciTechcare), Instituto Politécnico, Leiria - R. de Santo André, Leiria, 2410, Portugal.
Gabriela SantosCenter for Innovative Care and Health Technology (ciTechcare), Instituto Politécnico, Leiria - R. de Santo André, Leiria, 2410, Portugal.
Osvaldo SantosInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
Carolina AlmeidaServiço de Psiquiatria e Saúde Mental, Centro Hospitalar de Leiria - Hospital de Santo André, R. de Santo André, Leiria, 2410-197, Portugal.
Licínia GanançaDepartamento de Psiquiatria e Saúde Mental, Clínica Universitária de Psiquiatria e Psicologia Médica, Centro Hospitalar Universitário de Lisboa Norte, Lisbon, Portugal.
Rui C CamposComprehensive Health Research Center, Department of Psychology, School of Social Sciences, University of Évora, Évora, Portugal.
José CamolasInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
Alda Pereira da SilvaInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
Maria Pedro Sucena GuarinoCenter for Innovative Care and Health Technology (ciTechcare), Instituto Politécnico, Leiria - R. de Santo André, Leiria, 2410, Portugal.
Maria João HeitorInstituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa - Av, Lisboa, 1649-028, Portugal.
University of Lisbon · PTInstituto Politécnico de Leiria · PTCentro Hospitalar Lisboa Norte · PTHospital de Santo António · PTUniversidade Católica Portuguesa · PTUniversity of Évora · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMajor 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.

methodsThis 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.

Indexed as

Diet, MediterraneanMajor Depressive DisorderAdolescentAdultAgedBiomarkersCounselingHumansInflammationMiddle AgedQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeYoung AdultBiomarkersDepressionInflammationMajor depressive disorderMediterranean DietRandomized Controlled Trial

Identifiers

PMID37016319
PMCPMC10074649
OpenAlexW4362600764

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.