Q3136871 (Q3136871): Difference between revisions
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(Created claim: summary (P836): OBJECTIVE SUMMARY: 1) assess the effect that the 2-year intervention with Mediterranean Diet (MD) supplemented with virgin olive oil (AOV) and nuts (FS) (compared to control group without dietary intervention) has on the risk of recurrent depressive disorder in patients in total or partial remission of unipolar depressive disorder. It will be analysed whether changes in residual symptoms (2), quality of life (CV)(3), biochemical parameters (4),...) |
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OBJECTIVE SUMMARY: 1) assess the effect that the 2-year intervention with Mediterranean Diet (MD) supplemented with virgin olive oil (AOV) and nuts (FS) (compared to control group without dietary intervention) has on the risk of recurrent depressive disorder in patients in total or partial remission of unipolar depressive disorder. It will be analysed whether changes in residual symptoms (2), quality of life (CV)(3), biochemical parameters (4), and the risk of medical/psychiatric co-morbidities (5) are higher in the intervention group. Finally, the microbiota and its changes in both groups will be compared (6). METHODS: Multicenter clinical trial with 2 intervention arms (DM vs. control) for 2 years. Adult patients with a history of unipolar depressive episode in partial or total remission status (Montgomery-Asberg questionnaire assessment and structured SCID-I interview) will be included. Patients with current depression, common psychiatric disorders or problems following dietary recommendations will be excluded. A relapse rate of 35 % in the DM group and 50 % in the control group shall be considered (Hazard Ratio: 0,7). With 90 % power and 5 % alpha error, a sample size of 480 participants (500 to account for possible losses) is estimated. The intervention will be done through postal mail (sending information and recipes), email, telephone and new technologies (webpage/applic.mobile) with regular contacts with psychiatrists and dietitians and sending AOV and FS free of charge. The information will be collected with validated questionnaires of diet, physical act, CV, or symptoms using email, web or telephone. The analyses will be done for intent to treat. (English) | |||||||||||||||
| Property / summary: OBJECTIVE SUMMARY: 1) assess the effect that the 2-year intervention with Mediterranean Diet (MD) supplemented with virgin olive oil (AOV) and nuts (FS) (compared to control group without dietary intervention) has on the risk of recurrent depressive disorder in patients in total or partial remission of unipolar depressive disorder. It will be analysed whether changes in residual symptoms (2), quality of life (CV)(3), biochemical parameters (4), and the risk of medical/psychiatric co-morbidities (5) are higher in the intervention group. Finally, the microbiota and its changes in both groups will be compared (6). METHODS: Multicenter clinical trial with 2 intervention arms (DM vs. control) for 2 years. Adult patients with a history of unipolar depressive episode in partial or total remission status (Montgomery-Asberg questionnaire assessment and structured SCID-I interview) will be included. Patients with current depression, common psychiatric disorders or problems following dietary recommendations will be excluded. A relapse rate of 35 % in the DM group and 50 % in the control group shall be considered (Hazard Ratio: 0,7). With 90 % power and 5 % alpha error, a sample size of 480 participants (500 to account for possible losses) is estimated. The intervention will be done through postal mail (sending information and recipes), email, telephone and new technologies (webpage/applic.mobile) with regular contacts with psychiatrists and dietitians and sending AOV and FS free of charge. The information will be collected with validated questionnaires of diet, physical act, CV, or symptoms using email, web or telephone. The analyses will be done for intent to treat. (English) / rank | |||||||||||||||
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| Property / summary: OBJECTIVE SUMMARY: 1) assess the effect that the 2-year intervention with Mediterranean Diet (MD) supplemented with virgin olive oil (AOV) and nuts (FS) (compared to control group without dietary intervention) has on the risk of recurrent depressive disorder in patients in total or partial remission of unipolar depressive disorder. It will be analysed whether changes in residual symptoms (2), quality of life (CV)(3), biochemical parameters (4), and the risk of medical/psychiatric co-morbidities (5) are higher in the intervention group. Finally, the microbiota and its changes in both groups will be compared (6). METHODS: Multicenter clinical trial with 2 intervention arms (DM vs. control) for 2 years. Adult patients with a history of unipolar depressive episode in partial or total remission status (Montgomery-Asberg questionnaire assessment and structured SCID-I interview) will be included. Patients with current depression, common psychiatric disorders or problems following dietary recommendations will be excluded. A relapse rate of 35 % in the DM group and 50 % in the control group shall be considered (Hazard Ratio: 0,7). With 90 % power and 5 % alpha error, a sample size of 480 participants (500 to account for possible losses) is estimated. The intervention will be done through postal mail (sending information and recipes), email, telephone and new technologies (webpage/applic.mobile) with regular contacts with psychiatrists and dietitians and sending AOV and FS free of charge. The information will be collected with validated questionnaires of diet, physical act, CV, or symptoms using email, web or telephone. The analyses will be done for intent to treat. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 13:40, 12 October 2021
Project Q3136871 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3136871 in Spain |
Statements
77,775.0 Euro
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91,500.0 Euro
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85.0 percent
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1 January 2017
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31 March 2020
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UNIVERSIDAD DE LAS PALMAS DE GRAN CANARIA
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28°7'43.93"N, 15°26'5.64"W
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35016
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RESUMEN OBJETIVOS: 1) valorar el efecto que la intervención durante 2 años con Dieta Mediterránea (DM) suplementada con aceite de oliva virgen (AOV) y frutos secos (FS) (comparado con grupo control sin intervención dietética) tiene en el riesgo de trastorno depresivo recurrente en pacientes en remisión total o parcial de trastorno depresivo unipolar. Se analizará si los cambios en los síntomas residuales (2), calidad de vida (CV)(3), parámetros bioquímicos (4), y el riesgo de co-morbilidades médicas/psiquiátricas (5) son mayores en el grupo de intervención. Por último, se comparará la microbiota y sus cambios en ambos grupos (6). METODOS: Ensayo clínico multicéntrico con 2 brazos de intervención (DM vs. control) durante 2 años. Se incluirán pacientes adultos con antecedentes de episodio depresivo unipolar en estado de remisión parcial o total (valoración con cuestionario Montgomery-Asberg y entrevista estructurada SCID-I). Se excluirán pacientes con depresión actual, trastornos psiquiátricos comórbidos o con problemas para seguir las recomendaciones dietéticas. Se considerará tasa de recaída del 35% en el grupo DM y del 50% en el grupo control (Hazard Ratio: 0,7). Con potencia del 90% y error alfa del 5%, se estima un tamaño de muestra 480 participantes (500 para contabilizar posible pérdidas). La intervención se hará a través del correo postal (envío de información y recetas), email, teléfono y nuevas tecnologías (página Web/aplic.móvil) con contactos periódicos con psiquiatras y dietistas y el envío de AOV y FS de forma gratuita. La información se recogerá con cuestionarios validados de dieta, act. física, CV, o síntomas empleando el correo, la Web o el teléfono. Los análisis se harán por intención de tratar. (Spanish)
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OBJECTIVE SUMMARY: 1) assess the effect that the 2-year intervention with Mediterranean Diet (MD) supplemented with virgin olive oil (AOV) and nuts (FS) (compared to control group without dietary intervention) has on the risk of recurrent depressive disorder in patients in total or partial remission of unipolar depressive disorder. It will be analysed whether changes in residual symptoms (2), quality of life (CV)(3), biochemical parameters (4), and the risk of medical/psychiatric co-morbidities (5) are higher in the intervention group. Finally, the microbiota and its changes in both groups will be compared (6). METHODS: Multicenter clinical trial with 2 intervention arms (DM vs. control) for 2 years. Adult patients with a history of unipolar depressive episode in partial or total remission status (Montgomery-Asberg questionnaire assessment and structured SCID-I interview) will be included. Patients with current depression, common psychiatric disorders or problems following dietary recommendations will be excluded. A relapse rate of 35 % in the DM group and 50 % in the control group shall be considered (Hazard Ratio: 0,7). With 90 % power and 5 % alpha error, a sample size of 480 participants (500 to account for possible losses) is estimated. The intervention will be done through postal mail (sending information and recipes), email, telephone and new technologies (webpage/applic.mobile) with regular contacts with psychiatrists and dietitians and sending AOV and FS free of charge. The information will be collected with validated questionnaires of diet, physical act, CV, or symptoms using email, web or telephone. The analyses will be done for intent to treat. (English)
12 October 2021
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Palmas de Gran Canaria, Las
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Identifiers
PI16_01274
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