Effectiveness and cost-utility of a Mediterranean Lifestyle program in the prevention and treatment of subclinical depression, mild and moderate in Primary Care. (Q3151266): Difference between revisions
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(Created claim: summary (P836): Objetivo:Analizar effectiveness and cost-utility as an adjunct treatment of subclinical depression, mild or moderate in Primary Care patients of Mediterranean lifestyle recommendations. The effectiveness of ICT monitoring and the effectiveness of the intervention in chronic disease will also be analysed. Methodology: Description: Pragmatic clinical multicenter randomised in 3 parallel groups. Subjects of study: Primary care patients with mi...) |
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Effectiveness and cost-utility of a Mediterranean Lifestyle program in the prevention and treatment of subclinical depression, mild and moderate in Primary Care. | |||
Revision as of 15:25, 12 October 2021
Project Q3151266 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Effectiveness and cost-utility of a Mediterranean Lifestyle program in the prevention and treatment of subclinical depression, mild and moderate in Primary Care. |
Project Q3151266 in Spain |
Statements
21,000.0 Euro
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42,000.0 Euro
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50.0 percent
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1 January 2019
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31 March 2022
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INSTITUTO DE INVESTIGACION SANITARIA ARAGON
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41°39'7.67"N, 0°52'51.38"W
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50297
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Objetivo:Analizar la efectividad y coste-utilidad como tratamiento coadyuvante de la depresión subclínica, leve o moderada en pacientes de Atención Primaria de las recomendaciones de estilos de vida mediterráneo. Se analizará también la efectividad de una monitorización mediante TICs, y la efectividad de la intervención en patología crónica comórbida. Metodología: Diseño:Ensayo clínico pragmático multicéntrico randomizado en 3 grupos paralelos. Sujetos de estudio: Pacientes de atención primaria con depresión sublínica, leve o moderada. Tamaño Muestral: Será necesario reclutar 339 pacientes para conseguir demostrar una reducción de al menos 4,8 puntos en la escala Beck de depresión. Intervenciones: 1º tratamiento antidepresivo habitual con consejo psicológico y/o psicofármacos a cargo del médico de atención primaria (TAU); 2ª TAU + EM: estilo de vida mediterránea: programa en el que se trabajará semanalmente en 8 sesiones de 2 horas de forma grupal en mejorar los siguientes aspectos: actividad física diaria + adherencia al patrón de dieta mediterránea + higiene del sueño + exposición cuidadosa a la luz ambiental. 3º TAU + EM+M: recomendaciones de estilo de vida mediterránea (punto anterior) + monitorización mediante TICs. Mediciones: La variable principal será la sintomatología depresiva evaluada mediante el BDI II y las variables secundarias serán la calidad de vida, la utilización de recursos sanitarios y sociales, y variables relacionadas con los factores personales que influyen en la adherencia a las pautas de modificación de conducta. (Spanish)
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Objetivo:Analizar effectiveness and cost-utility as an adjunct treatment of subclinical depression, mild or moderate in Primary Care patients of Mediterranean lifestyle recommendations. The effectiveness of ICT monitoring and the effectiveness of the intervention in chronic disease will also be analysed. Methodology: Description: Pragmatic clinical multicenter randomised in 3 parallel groups. Subjects of study: Primary care patients with mild or moderate sublinical depression. Size Muestral: It will be necessary to recruit 339 patients to demonstrate a reduction of at least 4.8 points on the Beck scale of depression. Interventions: 1st regular antidepressant treatment with psychological advice or psychopharmaceuticals provided by the primary care physician (TAU); 2ND TAU + EM: Mediterranean lifestyle: programme that will work weekly in 8 sessions of 2 hours in a group to improve the following aspects: daily physical activity + adherence to the Mediterranean diet pattern + sleep hygiene + careful exposure to ambient light. 3 RD TAU + EM+M: Mediterranean lifestyle recommendations (previous point) + ICT monitoring. Measurements: The main variable will be the depressive symptomatology evaluated by BDI II and the secondary variables will be the quality of life, the use of health and social resources, and variables related to personal factors that influence adherence to behavioral modification patterns. (English)
12 October 2021
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Zaragoza
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Identifiers
PI18_01336
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