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

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).

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

“…We used data from an ongoing RCT of metacognitive training with an unselected sample of patients with SSD [ 33 ] and we compared those participants who consented to installation (users) of a passive smartphone-based EMA app, eB2, with those who did not (nonusers) in order to investigate eB2 acceptability and the factors that predicted the acceptability. First, as postulated, acceptability was lower than 50% (approximately one-third of the participants), thereby indicating low recruitment.…”

“…The participants in this study were from an ongoing RCT of metacognitive training, which is being carried out at the Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) [ 33 ]. Briefly, these outpatients (age 18-64 years) with an SSD diagnosis (F20-29 of 10th revision of the International Statistical Classification of Diseases and Related Health Problems), according to the Mini International Neuropsychiatric Interview, 5th edition [ 34 ], from June 10, 2019 to March 11, 2020, were considered to be eligible.…”

“…Clinical insight, which was the primary outcome of the RCT [ 33 ], was assessed with the Spanish version [ 42 ] of the Schedule for Assessment of Insight [ 43 ]; it provides scores on global insight and 3 insight dimensions: illness recognition, symptom relabeling, and treatment compliance. The higher the score, greater the insight.…”

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

“…Baseline data from a randomised controlled trial (RCT) of metacognitive training [ 36 ], which was carried out at the Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) from June 2019 to September 2020, were used for this study. Briefly, those outpatients (age 18–64 years) diagnosed with SSD, based on the Mini International Neuropsychiatric Interview, 5th Edition (MINI) [ 37 ], were approached and invited to participate in the RCT.…”

Investigating the Contribution of Decision-Making, Cognitive Insight, and Theory of Mind in Insight in Schizophrenia: A Cross-Sectional Study

“…Participants came from an ongoing randomized controlled trial (RCT) of metacognitive training (MCT) [30], which has been carried out at the Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) since June 2019. Recruitment therefore began at the same time as MCT was first delivered in the hospital.…”