RT Journal Article
T1 Study protocol of a randomised clinical trial testing whether metacognitive training can improve insight and clinical outcomes in schizophrenia
A1 López-Morinigo, Javier-David
A1 González Ruiz-Ruano, Verónica
A1 Sánchez Escribano Martínez, Adela
A1 Mata-Iturralde, Laura
A1 Muñoz-Lorenzo, Laura
A1 Sánchez-Alonso, Sergio
A1 Artés Rodríguez, Antonio
A1 David, Anthony S.
A1 Baca-García, Enrique
AB Background: 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).
PB BioMed Central Ltd. Part of Springer Nature.
SN 1471-244X
YR 2020
FD 2020-01-29
LK https://hdl.handle.net/10016/33347
UL https://hdl.handle.net/10016/33347
LA eng
NO This 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.
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