López-Morinigo, Javier-DavidGonzález Ruiz-Ruano, VerónicaSánchez Escribano Martínez, AdelaMata-Iturralde, LauraMuñoz-Lorenzo, LauraSánchez-Alonso, SergioArtés Rodríguez, AntonioDavid, Anthony S.Baca-García, Enrique2021-09-302021-09-302020-01-29BMC Psychiatry, 20, 30 (2020), 11 p.1471-244Xhttps://hdl.handle.net/10016/33347Background: 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).11eng© The Author(s). 2020.This 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.Atribución 3.0 EspañaEcological momentary assessmentInsightMetacognitive trainingSchizophrenia spectrum disorders (SSD)research articleBiología y Biomedicinahttps://doi.org/10.1186/s12888-020-2431-xopen access13011BMC Psychiatry20AR/0000025507