000061340 001__ 61340
000061340 005__ 20170520135542.0
000061340 0247_ $$2doi$$a10.1186/1471-244X-13-171
000061340 0248_ $$2sideral$$a98736
000061340 037__ $$aART-2013-98736
000061340 041__ $$aeng
000061340 100__ $$aBellón, J.A.
000061340 245__ $$aPreventing 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)
000061340 260__ $$c2013
000061340 5060_ $$aAccess copy available to the general public$$fUnrestricted
000061340 5203_ $$aBackground: 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.
000061340 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII/PS09-00461$$9info:eu-repo/grantAgreement/ES/ISCIII/PS09-00849$$9info:eu-repo/grantAgreement/ES/ISCIII/PS09-01095$$9info:eu-repo/grantAgreement/ES/ISCIII/PS09-02147$$9info:eu-repo/grantAgreement/ES/ISCIII/PS09-02272
000061340 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000061340 590__ $$a2.237$$b2013
000061340 591__ $$aPSYCHIATRY$$b65 / 134 = 0.485$$c2013$$dQ2$$eT2
000061340 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000061340 700__ $$aConejo-Cerón, S.
000061340 700__ $$aMoreno-Peral, P.
000061340 700__ $$aKing, M.
000061340 700__ $$aNazareth, I.
000061340 700__ $$aMartín-Pérez, C.
000061340 700__ $$aFernández-Alonso, C.
000061340 700__ $$aBallesta-Rodríguez, M.I.
000061340 700__ $$aFernández, A.
000061340 700__ $$aAiarzaguena, J.M.
000061340 700__ $$aMontón-Franco, C.$$uUniversidad de Zaragoza
000061340 700__ $$aIbanez-Casas, I.
000061340 700__ $$aRodríguez-Sánchez, E.
000061340 700__ $$aRodríguez-Bayón, A.
000061340 700__ $$aSerrano-Blanco, A.
000061340 700__ $$aGómez, M. C.
000061340 700__ $$aLaFuente, P.
000061340 700__ $$aMuñoz García, M.M.
000061340 700__ $$aMínguez-Gonzalo, P.
000061340 700__ $$aAraujo, L.
000061340 700__ $$aPalao, D.
000061340 700__ $$aEspinosa-Cifuentes, M.
000061340 700__ $$aZubiaga, F.
000061340 700__ $$aNavas-Campaña, D.
000061340 700__ $$aMendive, J.
000061340 700__ $$aAranda-Regules, J.
000061340 700__ $$aRodriguez-Morejón, A.
000061340 700__ $$aSalvador-Carulla, L.
000061340 700__ $$ade Dios Luna, J.
000061340 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDepartamento de Medicina, Psiquiatría y Dermatología$$cMedicina
000061340 773__ $$g13 (2013), 171 [16 pp]$$pBMC Psychiatry$$tBMC Psychiatry$$x1471-244X
000061340 8564_ $$s1127734$$uhttps://zaguan.unizar.es/record/61340/files/texto_completo.pdf$$yVersión publicada
000061340 8564_ $$s99586$$uhttps://zaguan.unizar.es/record/61340/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000061340 909CO $$ooai:zaguan.unizar.es:61340$$particulos$$pdriver
000061340 951__ $$a2017-05-19-14:53:11
000061340 980__ $$aARTICLE