期刊论文详细信息
BMC Psychiatry
Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study)
Juan de Dios Luna1,14  Luis Salvador-Carulla2,23  Alberto Rodriguez-Morejón1,18  Jose Manuel Aranda-Regules9  Juan Mendive6  Desirée Navas-Campaña1,12  Fernando Zubiaga2,22  Maite Espinosa-Cifuentes1  Diego Palao1,19  Luz Araujo1,12  Pilar Mínguez-Gonzalo1,15  María del Mar Muñoz-García1,12  Pilar LaFuente1,11  María Cruz Gómez1  Antoni Serrano-Blanco1,17  Antonina Rodríguez-Bayón1,13  Emiliano Rodríguez-Sánchez2  Inmaculada Ibanez-Casas5  Carmen Montón-Franco7  José María Aiarzaguena1,10  Anna Fernández1,17  María Isabel Ballesta-Rodríguez3  Carmen Fernández-Alonso2,21  Carlos Martín-Pérez1,16  Irwin Nazareth2,20  Michael King8  Patricia Moreno-Peral1,12  Sonia Conejo-Cerón1,12  Juan Ángel Bellón4 
[1] Unidad de Investigación de Atención Primaria, Osakidetza, Bilbao, Spain;Centro de Salud Miguel Armijo, Salamanca, Spain;Centro de Salud Federico del Castillo, Jaén, Spain;Departamento de Medicina Preventiva, Facultad de Medicina, Universidad de Málaga, Campus de Teatinos 29071, Málaga, Spain;“Centro de Investigación Biomédica en Red de Salud Mental” CIBERSAM, Universidad de Granada, Granada, Spain;Centro de Salud La Mina, Institut Català de la Salut, Barcelona, Spain;Centro de Salud Casablanca. Instituto Aragonés de Ciencias de la Salud. IIS Aragón. Departamento de Medicina y Psiquiatría, Universidad de Zaragoza, Spain;Mental Health Sciences, Faculty of Brain Sciences, UCL, London, UK;Centro de Salud El Torcal, Distrito Sanitario Málaga, Málaga, Spain;Centro de Salud San Ignacio, Unidad de Investigación de Atención Primaria, Osakidetza, Bilbao, Spain;Centro de Salud Andorra, Teruel, Instituto Aragonés de Ciencias de la Salud, Teruel, Zaragoza, Spain;Fundación IMABIS, Unidad de Investigación del Distrito de Atención Primaria de Málaga, Málaga, Spain;Centro de Salud San José, Linares, Jaén, Spain;Departamento de Bioestadística, Universidad de Granada, Granada, Spain;Unidad de Investigación de Atención Primaria, Valladolid, Spain;Centro de Salud Marquesado, Área Nordeste de Granada, Granada, Spain;Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Barcelona, Spain;Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Málaga, Málaga, Spain;Hospital Parc Taulí, Servei de Salut Mental, Sabadell, Barcelona, Spain;Department of Primary Care and Population Health, UCL, London, UK;Servicio de Programas Asistenciales, Gerencia Regional de Salud, Valladolid, Spain;Unidad de Investigación de Atención Primaria, Centro de Salud Arrabal, Zaragoza, Spain;Centre for Disability Research and Policy, Faculty of Health Sciences, University of Sydney, Sydney, Australia
关键词: Randomized controlled trial;    Primary health care;    Primary prevention;    Depression;   
Others  :  1124022
DOI  :  10.1186/1471-244X-13-171
 received in 2013-05-09, accepted in 2013-05-29,  发布年份 2013
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【 摘 要 】

Background

The ‘predictD algorithm’ provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression.

Methods/Design

This is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system.

Discussion

To our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations.

Trial registration

ClinicalTrials.gov identifier: NCT01151982

【 授权许可】

   
2013 Bellón et al.; licensee BioMed Central Ltd.

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