Please use this identifier to cite or link to this item: http://hdl.handle.net/10174/36535

Title: 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
Authors: Sousa Santos, Nuno
Fialho, Mónia
Madeira, Teresa
Clara, Cátia
Veiga, Sofia
Martins, Raquel
Barros, Neuza
Sanots, Gabriela
Sanots, Osvaldo
Almeida, Carolina
Ganança, Licínia
Campos, Rui C
Camola, José
Pereira da Silva, Alda
Sucena Guarino, Maria Pedro
Heitor, Maria João
Issue Date: 2023
Publisher: BMC Psychiatry
Abstract: Background 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
URI: http://hdl.handle.net/10174/36535
Type: article
Appears in Collections:PSI - Publicações - Artigos em Revistas Internacionais Com Arbitragem Científica
CHRC - Publicações - Artigos em Revistas Internacionais Com Arbitragem Científica

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