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

authors

  • Lopez-Morinigo, Javier David
  • Gonzalez Ruiz-Ruano, Veronica
  • Sanchez Escribano Martinez, Adela
  • BARRIGÓN ESTEVEZ, MARÍA LUISA
  • Mata-Iturralde, Laura
  • Muñoz-Lorenzo, Laura
  • Sanchez-Alonso, Sergio
  • ARTES RODRIGUEZ, ANTONIO
  • David, Anthony S.
  • BACA GARCIA, ENRIQUE

publication date

  • January 2020

start page

  • 1

end page

  • 11

volume

  • 20

International Standard Serial Number (ISSN)

  • 1471-244X

abstract

  • BackgroundAlthough 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. MethodsThis 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. DiscussionTo 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 registrationClinicalTrials.gov: NCT04104347. Date of registration: 26/09/2019 (Retrospectively registered).

keywords

  • ecological momentary assessment; insight; metacognitive training; schizophrenia spectrum disorders