ABSTRACT: Abstract Background Insight in schizophrenia spectrum disorders (SSD) has been linked with positive outcomes. However, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight in SSD has led to speculation that metacognitive training (MCT) may improve insight and clinical outcomes in SSD. Methods Design: Single-center, assessor-blind, parallel-group, randomised controlled trial (RCT). Sample: Participants are recruited from the outpatient clinic of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) over June-December 2019. Inclusion criteria: i) age: 18–64 years, both inclusive, at the study inception; ii) diagnosis: SSD based on the Mini International Neuropsychiatric Interview (Sheehan et al., 1998) and iii) IQ>70 according to the Wechsler Adults Intelligence Scale-IV (Wechsler, 1981). Those with organic and drugs-induced psychosis, poor level of Spanish and/or lack of cooperativeness are excluded. Intervention: Participants are randomised to receive eight weekly group sessions of MCT or group psychoeducation (PSE) and they will be assessed at: T0) at baseline; T1) after treatment and T2) at 1-year follow-up, although follow-up data are not available yet. Co-primary outcome measures: clinical and cognitive insight dimensions, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) (Kemp & David, 1997), and the Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004), respectively. Secondary outcome measures: i)Symptom severity-Positive and Negative Syndrome Scale (Kay et al., 1987); ii)Functioning-General Assessment of Functioning (Endicott et al., 1976), World Health Organization Disability Scale (WHO, 2012) and Satisfaction Life Domains Scale (Carlson et al., 2009), and only at follow-up (T2) iii)Suicidal Behaviour and iv) Hospitalizations. Power calculations: To reach a power of ?=80% and detect a between-group difference of two points on the SAI-E total scores, which is considered to be clinically meaningful -effect size of 0.33-, the estimated sample size at the end of the study is n=126. Statistics: Student’s T-test and Mann-Whitney U tests were used as appropriate to compare between-group differences before- and after-treatment, i.e., the changes from baseline to post-treatment scores. The protocol of the study is registered at ClinicalTrials.gov (NCT04104347). Results n=49 subjects have been assessed at baseline so far (26 males, age: 47.0±10.2 years, diagnosis of schizophrenia -F20-ICD10-, n=36, 73.5%). Fifteen individuals (MCT: n=8; controls: n=7) have completed the treatment and the post-treatment assessment (T1). ‘After-treatment-T1 - baseline-T0’ scores difference means/medians between-group differences (MCT vs. PSE) were: SAI-E total insight 1.00 vs. -2.00, p=0.050; SAI-E illness awareness 0.62±2.20 vs. -0.43±1.62, p=0.316; SAI-E symptom relabelling 0.37±3.38 vs. -1.86±2.34, p=0.167; SAI-E treatment compliance 0.00 vs. 0.00, p>0.05,ns; BCIS self-reflectiveness 0.50±3.78 vs. -1.43±2.22, p=0.259, BCIS self-certainty 1.62±2.97 vs. 0.00±2.44, p=0.298 and BCIS Composite Index -1.13±5.62 vs. -2.17±3.49, p=0.698. Discussion This is the first RCT testing the effect of group MCT on insight (as primary outcome) in a sample of unselected patients with SSD in comparison with psychoeducation. Two main findings emerged from the results. First, MCT appears to improve clinical and cognitive insight in SSD. Second, MCT was shown to be superior to PSE in changing insight. Whether the above MCT-related insight improvement is maintained at longer-term and whether this has an impact on clinical and social outcomes are yet to be established, which will be properly looked at in this trial.
