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Study protocol of a randomised clinical trial testing whether metacognitive training can improve insight and clinical outcomes in schizophrenia

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dc.affiliation.dptoUC3M. Departamento de Teoría de la Señal y Comunicacioneses
dc.contributor.authorLópez-Morinigo, Javier-David
dc.contributor.authorGonzález Ruiz-Ruano, Verónica
dc.contributor.authorSánchez Escribano Martínez, Adela
dc.contributor.authorMata-Iturralde, Laura
dc.contributor.authorMuñoz-Lorenzo, Laura
dc.contributor.authorSánchez-Alonso, Sergio
dc.contributor.authorArtés Rodríguez, Antonio
dc.contributor.authorDavid, Anthony S.
dc.contributor.authorBaca-García, Enrique
dc.contributor.funderComunidad de Madrides
dc.contributor.funderEuropean Commissionen
dc.date.accessioned2021-09-30T11:58:00Z
dc.date.available2021-09-30T11:58:00Z
dc.date.issued2020-01-29
dc.description.abstractBackground: Although insight in schizophrenia spectrum disorders (SSD) has been associated with positive outcomes, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight suggests that metacognitive training (MCT) may improve insight and clinical outcomes in SSD, although this remains to be established. Methods: This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the efficacy of MCT for improving insight (primary outcome), including clinical and cognitive insight, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Scale (BCIS), respectively, in (at least) n =126 outpatients with SSD at three points in time: i) at baseline (T0); ii) after treatment (T1) and iii) at 1-year follow-up (T2). SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes at T1 and T2, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants. Discussion: To the best of our knowledge, this will be the first RCT testing the effect of group MCT on multiple insight dimensions (as primary outcome) in a sample of unselected patients with SSD, including several secondary outcomes of clinical relevance, namely symptom severity, functioning, which will also be evaluated with EMA, hospitalizations and suicidal behaviour. Trial registration: Clinical Trials.gov: NCT04104347. Date of registration: 26/09/2019 (Retrospectively registered).en
dc.description.sponsorshipThis study was supported by the Universidad Autónoma de Madrid and European Union via the Intertalentum Project Grant-Marie Skłodowska Curie Actions (GA 713366) to JDLM who is the Princiapl Investigator. This grant therefore funds both JDLM’s salary and the consumable expenses related to the study. JDLM, VGRR, ASEM, MLBE, LMI, LML, SSA, AAR and EBG’s salaries come from the Hospital Universitario Fundación Jiménez Díaz, where this study is currently being carried out, which therefore provides the necessary institutional/departmental support for its development. Additional departmental support concerning the use of Ecological Momentary Assessment (see Methods section, page 11 -last paragraph- and page 12 –first paragraph-, for details) is provided by the Instituto de Salud Carlos III (Madrid, Spain) (ISCIII PI16/01852) and the Madrid Regional Government (Madrid, Spain) (B2017/BMD-3740 AGES-CM 2CM; Y2018/TCS-4705 PRACTICO-CM). ASD acknowledges funding supports from University College London, which covers his salary.en
dc.format.extent11es
dc.identifier.bibliographicCitationBMC Psychiatry, 20, 30 (2020), 11 p.en
dc.identifier.doihttps://doi.org/10.1186/s12888-020-2431-x
dc.identifier.issn1471-244X
dc.identifier.publicationfirstpage1es
dc.identifier.publicationissue30es
dc.identifier.publicationlastpage11es
dc.identifier.publicationtitleBMC Psychiatryen
dc.identifier.publicationvolume20es
dc.identifier.urihttps://hdl.handle.net/10016/33347
dc.identifier.uxxiAR/0000025507
dc.language.isoengen
dc.publisherBioMed Central Ltd. Part of Springer Nature.en
dc.relation.projectIDinfo:eu-repo/grantAgreement/EC/H2020/713366/InterTalentumen
dc.relation.projectIDComunidad de Madrid. B2017/BMD-3740/AGESes
dc.relation.projectIDComunidad de Madrid. Y2018/TCS-4705/PRACTICOes
dc.rights© The Author(s). 2020.en
dc.rightsThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.en
dc.rightsAtribución 3.0 España*
dc.rights.accessRightsopen accessen
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/es/*
dc.subject.ecienciaBiología y Biomedicinaes
dc.subject.otherEcological momentary assessmenten
dc.subject.otherInsighten
dc.subject.otherMetacognitive trainingen
dc.subject.otherSchizophrenia spectrum disorders (SSD)en
dc.titleStudy protocol of a randomised clinical trial testing whether metacognitive training can improve insight and clinical outcomes in schizophreniaen
dc.typeresearch article*
dc.type.hasVersionVoR*
dspace.entity.typePublication
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