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)

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 effe...

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Autores: Bellón, J.A., Conejo-Cerón, S., Moreno-Peral, P., King, M., Nazareth, I., Martín-Pérez, C., Fernández-Alonso, C., Ballesta-Rodríguez, M.I., Fernández, A., Aiarzaguena, J.M., Montón-Franco, C., Ibanez-Casas, I., Rodríguez-Sánchez, E., Rodríguez-Bayón, A., Serrano-Blanco, A., Gómez, M. C., LaFuente, P., Muñoz García, M.M., Mínguez-Gonzalo, P., Araujo, L., Palao, D., Espinosa-Cifuentes, M., Zubiaga, F., Navas-Campaña, D., Mendive, J., Aranda-Regules, J., Rodriguez-Morejón, A., Salvador-Carulla, L., de Dios Luna, J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2013
País:España
Institución:Universidad de Zaragoza
Repositorio:Zaguán. Repositorio Digital de la Universidad de Zaragoza
OAI Identifier:oai:zaguan.unizar.es:61340
Acceso en línea:http://zaguan.unizar.es/record/61340
Access Level:acceso abierto
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spelling 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)Bellón, J.A.Conejo-Cerón, S.Moreno-Peral, P.King, M.Nazareth, I.Martín-Pérez, C.Fernández-Alonso, C.Ballesta-Rodríguez, M.I.Fernández, A.Aiarzaguena, J.M.Montón-Franco, C.Ibanez-Casas, I.Rodríguez-Sánchez, E.Rodríguez-Bayón, A.Serrano-Blanco, A.Gómez, M. C.LaFuente, P.Muñoz García, M.M.Mínguez-Gonzalo, P.Araujo, L.Palao, D.Espinosa-Cifuentes, M.Zubiaga, F.Navas-Campaña, D.Mendive, J.Aranda-Regules, J.Rodriguez-Morejón, A.Salvador-Carulla, L.de Dios Luna, J.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: NCT01151982.2013info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://zaguan.unizar.es/record/61340reponame:Zaguán. Repositorio Digital de la Universidad de Zaragozainstname:Universidad de ZaragozaInglésinfo:eu-repo/grantAgreement/ES/ISCIII/PS09-00461info:eu-repo/grantAgreement/ES/ISCIII/PS09-00849info:eu-repo/grantAgreement/ES/ISCIII/PS09-01095info:eu-repo/grantAgreement/ES/ISCIII/PS09-02147info:eu-repo/grantAgreement/ES/ISCIII/PS09-02272info:eu-repo/semantics/openAccessoai:zaguan.unizar.es:613402026-05-29T13:59:51Z
dc.title.none.fl_str_mv 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)
title 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)
spellingShingle 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)
Bellón, J.A.
title_short 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_sort 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)
dc.creator.none.fl_str_mv Bellón, J.A.
Conejo-Cerón, S.
Moreno-Peral, P.
King, M.
Nazareth, I.
Martín-Pérez, C.
Fernández-Alonso, C.
Ballesta-Rodríguez, M.I.
Fernández, A.
Aiarzaguena, J.M.
Montón-Franco, C.
Ibanez-Casas, I.
Rodríguez-Sánchez, E.
Rodríguez-Bayón, A.
Serrano-Blanco, A.
Gómez, M. C.
LaFuente, P.
Muñoz García, M.M.
Mínguez-Gonzalo, P.
Araujo, L.
Palao, D.
Espinosa-Cifuentes, M.
Zubiaga, F.
Navas-Campaña, D.
Mendive, J.
Aranda-Regules, J.
Rodriguez-Morejón, A.
Salvador-Carulla, L.
de Dios Luna, J.
author Bellón, J.A.
author_facet Bellón, J.A.
Conejo-Cerón, S.
Moreno-Peral, P.
King, M.
Nazareth, I.
Martín-Pérez, C.
Fernández-Alonso, C.
Ballesta-Rodríguez, M.I.
Fernández, A.
Aiarzaguena, J.M.
Montón-Franco, C.
Ibanez-Casas, I.
Rodríguez-Sánchez, E.
Rodríguez-Bayón, A.
Serrano-Blanco, A.
Gómez, M. C.
LaFuente, P.
Muñoz García, M.M.
Mínguez-Gonzalo, P.
Araujo, L.
Palao, D.
Espinosa-Cifuentes, M.
Zubiaga, F.
Navas-Campaña, D.
Mendive, J.
Aranda-Regules, J.
Rodriguez-Morejón, A.
Salvador-Carulla, L.
de Dios Luna, J.
author_role author
author2 Conejo-Cerón, S.
Moreno-Peral, P.
King, M.
Nazareth, I.
Martín-Pérez, C.
Fernández-Alonso, C.
Ballesta-Rodríguez, M.I.
Fernández, A.
Aiarzaguena, J.M.
Montón-Franco, C.
Ibanez-Casas, I.
Rodríguez-Sánchez, E.
Rodríguez-Bayón, A.
Serrano-Blanco, A.
Gómez, M. C.
LaFuente, P.
Muñoz García, M.M.
Mínguez-Gonzalo, P.
Araujo, L.
Palao, D.
Espinosa-Cifuentes, M.
Zubiaga, F.
Navas-Campaña, D.
Mendive, J.
Aranda-Regules, J.
Rodriguez-Morejón, A.
Salvador-Carulla, L.
de Dios Luna, J.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
description 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.
publishDate 2013
dc.date.none.fl_str_mv 2013
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://zaguan.unizar.es/record/61340
url http://zaguan.unizar.es/record/61340
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv info:eu-repo/grantAgreement/ES/ISCIII/PS09-00461
info:eu-repo/grantAgreement/ES/ISCIII/PS09-00849
info:eu-repo/grantAgreement/ES/ISCIII/PS09-01095
info:eu-repo/grantAgreement/ES/ISCIII/PS09-02147
info:eu-repo/grantAgreement/ES/ISCIII/PS09-02272
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv
publisher.none.fl_str_mv
dc.source.none.fl_str_mv reponame:Zaguán. Repositorio Digital de la Universidad de Zaragoza
instname:Universidad de Zaragoza
instname_str Universidad de Zaragoza
reponame_str Zaguán. Repositorio Digital de la Universidad de Zaragoza
collection Zaguán. Repositorio Digital de la Universidad de Zaragoza
repository.name.fl_str_mv
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