Study Protocol of a Randomised Clinical Trial Testing Whether Metacognitive Training Can Improve Insight and Clinical Outcomes in Schizophrenia

Overview

Journal BMC Psychiatry

Publisher Biomed Central

Specialty Psychiatry

Date 2020 Jan 31

PMID 31996174

Citations 3

Authors

Javier-David Lopez-Morinigo

Veronica Gonzalez Ruiz-Ruano

Adela Sanchez Escribano Martinez

Maria Luisa Barrigon Estevez

Laura Mata-Iturralde

Laura Munoz-Lorenzo

Sergio Sanchez-Alonso

Antonio Artes-Rodriguez

Anthony S David

Enrique Baca-Garcia

Affiliations

Soon will be listed here.

Abstract

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: ClinicalTrials.gov: NCT04104347. Date of registration: 26/09/2019 (Retrospectively registered).

Citing Articles

Decreased insight, but not self-stigma or belief about medicine, is associated with greater severity of delusions in a sample of long-stay patients with schizophrenia: a cross-sectional study.

Beainy C, Haddad C, Fekih-Romdhane F, Hallit S, Haddad G BMC Psychiatry. 2023; 23(1):222.

PMID: 37013492 PMC: 10069113. DOI: 10.1186/s12888-023-04711-1.

Investigating the Role of Insight, Decision-Making and Mentalizing in Functional Outcome in Schizophrenia: A Cross-Sectional Study.

Escobedo-Aedo P, Forjan-Gonzalez A, Martinez A, Ruiz-Ruano V, Sanchez-Alonso S, Mata-Iturralde L Behav Sci (Basel). 2022; 12(2).

PMID: 35200280 PMC: 8868582. DOI: 10.3390/bs12020028.

Use of Ecological Momentary Assessment Through a Passive Smartphone-Based App (eB2) by Patients With Schizophrenia: Acceptability Study.

Lopez-Morinigo J, Barrigon M, Porras-Segovia A, Ruiz-Ruano V, Escribano Martinez A, Escobedo-Aedo P J Med Internet Res. 2021; 23(7):e26548.

PMID: 34309576 PMC: 8367186. DOI: 10.2196/26548.

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