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

被引:2
作者
Sousa-Santos, Nuno [1 ,2 ,3 ]
Fialho, Monica [2 ,3 ]
Madeira, Teresa [2 ,3 ,8 ]
Clara, Catia [1 ]
Veiga, Sofia [2 ,3 ]
Martins, Raquel [2 ,3 ]
Barros, Neuza [1 ,2 ,3 ]
Santos, Gabriela [1 ]
Santos, Osvaldo [2 ,3 ]
Almeida, Carolina [4 ]
Gananca, Licinia [5 ]
Campos, Rui C. C. [6 ]
Camolas, Jose [2 ,3 ,7 ,8 ,9 ]
da Silva, Alda Pereira [2 ,3 ,10 ]
Guarino, Maria Pedro Sucena [1 ]
Heitor, Maria Joao [2 ,9 ,11 ]
机构
[1] Inst Politecn, Ctr Innovat Care & Hlth Technol ciTechcare, P-2410 Leiria, Portugal
[2] Univ Lisbon, Fac Med, Inst Saude Ambiental ISAMB, P-1649028 Lisbon, Portugal
[3] Univ Lisbon, Fac Med, Lab Associado TERRA, Av Prof Egas Moniz, P-1649028 Lisbon, Portugal
[4] Hosp Santo Andre, Ctr Hosp Leiria, Serv Psiquiatria & Saude Mental, P-2410197 Leiria, Portugal
[5] Ctr Hosp Univ Lisboa Norte, Dept Psiquiatria & Saude Mental, Clin Univ Psiquiatria & Psicol Med, Lisbon, Portugal
[6] Univ Evora, Comprehens Hlth Res Ctr, Sch Social Sci, Dept Psychol, Evora, Portugal
[7] Ctr Hosp Univ Lisboa Norte, Hosp Santa Maria, EPE, Av Prof Egas Moniz MB, P-1649028 Lisbon, Portugal
[8] Univ Lisbon, Fac Med, Lab Nutr, Av Prof Egas Moniz,Edificio Egas Moniz,Ala C,Piso, P-1649028 Lisbon, Portugal
[9] Univ Catolica Portuguesa, Fac Med, Estr Octavio Pato, P-2635631 Rio De Mouro, Sintra, Portugal
[10] Univ Lisbon, Clin Univ Med Geral & Familiar, Fac Med, Av Prof Egas Moniz MB, P-1649028 Lisbon, Portugal
[11] Hosp Beatriz Angelo, Dept Psiquiatria & Saude Mental, Av Carlos Teixeira 3, P-2674514 Loures, Portugal
关键词
Randomized Controlled Trial; Major depressive disorder; Depression; Mediterranean Diet; Inflammation; METAANALYSIS; PATTERNS;
D O I
10.1186/s12888-023-04705-z
中图分类号
R749 [精神病学];
学科分类号
100205 ;
摘要
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.DiscussionThis 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.
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页数:11
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