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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).

SUBMITTER: Lopez-Morinigo JD

PROVIDER: S-EPMC6990523 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Lopez-Morinigo Javier-David JD Ruiz-Ruano Verónica González VG Martínez Adela Sánchez Escribano ASE Estévez María Luisa Barrigón MLB Mata-Iturralde Laura L Muñoz-Lorenzo Laura L Sánchez-Alonso Sergio S Artés-Rodríguez Antonio A David Anthony S AS Baca-García Enrique E

BMC psychiatry 20200129 1

<h4>Background</h4>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.<h4>Methods</h4>This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the e ...[more]

PMID: 31996174

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Project description: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 β=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.

Project description:BackgroundPrevious studies have revealed the efficacy of metacognitive training for schizophrenia. However, the underlying mechanisms of metacognitive training on brain function alterations, including the default-mode network (DMN), remain unknown. The present study explored treatment effects of metacognitive training on functional connectivity of the brain regions in the DMN.MethodsForty-one patients with schizophrenia and 20 healthy controls were scanned using resting-state functional magnetic resonance imaging. Patients were randomly assigned to drug plus psychotherapy (DPP) and drug therapy (DT) groups. The DPP group received olanzapine and metacognitive training, and the DT group received only olanzapine for 8 weeks. Network homogeneity (NH) was applied to analyze the imaging data, and pattern classification techniques were applied to test whether abnormal NH deficits at baseline might be used to discriminate patients from healthy controls. Abnormal NH in predicting treatment response was also examined in each patient group.ResultsCompared with healthy controls, patients at baseline showed decreased NH in the bilateral ventral medial prefrontal cortex (MPFC), right posterior cingulate cortex (PCC)/precuneus, and bilateral precuneus and increased NH in the right cerebellum Crus II and bilateral superior MPFC. NH values in the right PCC/precuneus increased in the DPP group after 8 weeks of treatment, whereas no substantial difference in NH value was observed in the DT group. Support vector machine analyses showed that the accuracy, sensitivity, and specificity for distinguishing patients from healthy controls were more than 0.7 in the NH values of the right PCC/precuneus, bilateral ventral MPFC, bilateral superior MPFC, and bilateral precuneus regions. Support vector regression analyses showed that high NH levels at baseline in the bilateral superior MPFC could predict symptomatic improvement of positive and negative syndrome scale (PANSS) after 8 weeks of DPP treatment. No correlations were found between alterations in the NH values and changes in the PANSS scores/cognition parameters in the patients.ConclusionThis study provides evidence that metacognitive training is related to the modulation of DMN homogeneity in schizophrenia.

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

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

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