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A pilot 1-year follow-up randomised controlled trial comparing metacognitive training to psychoeducation in schizophrenia: effects on insight.

ABSTRACT: Poor insight in schizophrenia spectrum disorders (SSD) is linked with negative outcomes. This single-centre, assessor-blind, parallel-group 1-year follow-up randomised controlled trial (RCT) tested whether metacognitive training (MCT) (compared to psychoeducation) may improve insight and outcomes in outpatients with SSD assessed: at baseline (T0); after treatment (T1) and at 1-year follow-up (T2). Insight (primary outcome) was measured with (i) the Schedule for Assessment of Insight-Expanded version- (SAI-E), including illness recognition (IR), symptom relabelling (SR), treatment compliance (TC) and total insight scores (TIS); and (ii) the Beck Cognitive Insight Scale (BCIS). Between-group comparisons were nonsignificant, while within the MCT group (but not within controls) there was a significant medium effect size for improved TIS at T2 (d = 0.67, P = 0.02). Secondary outcomes included cognitive measures: Jumping to Conclusions (JTC), Theory of Mind (ToM), plus symptom severity and functioning. Compared to psychoeducation, MCT improved the PANSS excitement (d = 1.21, P = 0.01) and depressed (d = 0.76, P = 0.05) factors at T2; and a JTC task both at T1 (P = 0.016) and at T2 (P = 0.031). Participants in this RCT receiving MCT showed improved insight at 1-year follow-up, which was associated with better mood and reduced JTC cognitive bias. In this pilot study, no significant benefits on insight of MCT over psychoeducation were detected, which may have been due to insufficient power.

SUBMITTER: Lopez-Morinigo JD

PROVIDER: S-EPMC9886217 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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A pilot 1-year follow-up randomised controlled trial comparing metacognitive training to psychoeducation in schizophrenia: effects on insight.

Lopez-Morinigo Javier-David JD Martínez Adela Sánchez-Escribano AS Barrigón María Luisa ML Escobedo-Aedo Paula-Jhoana PJ Ruiz-Ruano Verónica González VG Sánchez-Alonso Sergio S Mata-Iturralde Laura L Muñoz-Lorenzo Laura L Cuadras Daniel D Ochoa Susana S Baca-García Enrique E David Anthony S AS

Schizophrenia (Heidelberg, Germany) 20230130 1

Poor insight in schizophrenia spectrum disorders (SSD) is linked with negative outcomes. This single-centre, assessor-blind, parallel-group 1-year follow-up randomised controlled trial (RCT) tested whether metacognitive training (MCT) (compared to psychoeducation) may improve insight and outcomes in outpatients with SSD assessed: at baseline (T0); after treatment (T1) and at 1-year follow-up (T2). Insight (primary outcome) was measured with (i) the Schedule for Assessment of Insight-Expanded ver ...[more]

PMID: 36717598

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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:BACKGROUND:Schizophrenia can be a severe and chronic illness characterised by lack of insight and poor compliance with treatment. Psychoeducational approaches have been developed to increase patients' knowledge of, and insight into, their illness and its treatment. It is supposed that this increased knowledge and insight will enable people with schizophrenia to cope in a more effective way with their illness, thereby improving prognosis. OBJECTIVES:To assess the effects of psychoeducational interventions compared with standard levels of knowledge provision. SEARCH STRATEGY:We searched the Cochrane Schizophrenia Group Trials Register (February 2010). SELECTION CRITERIA:All relevant randomised controlled trials focusing on psychoeducation for schizophrenia and/or related serious mental illnesses involving individuals or groups. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS:At least two review authors extracted data independently from included papers. We contacted authors of trials for additional and missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data. We used a fixed-effects model for heterogeneous dichotomous data. Where possible we also calculated the numbers needed to treat (NNT), as well as weighted means for continuous data. MAIN RESULTS:This review includes a total of 5142 participants (mostly inpatients) from 44 trials conducted between 1988 and 2009 (median study duration ˜ 12 weeks, risk of bias - moderate). We found that incidences of non-compliance were lower in the psychoeducation group in the short term (n = 1400, RR 0.52 CI 0.40 to 0.67, NNT 11 CI 9 to 16). This finding holds for the medium and long term. Relapse appeared to be lower in psychoeducation group (n = 1214, RR 0.70 CI 0.61 to 0.81, NNT 9 CI 7 to 14) and this also applied to readmission (n = 206, RR 0.71 CI 0.56 to 0.89, NNT 5 CI 4 to 13). Scale-derived data also suggested that psychoeducation promotes better social and global functioning. In the medium term, treating four people with schizophrenia with psychoeducation instead of standard care resulted in one additional person showing a clinical improvement. Evidence suggests that participants receiving psychoeducation are more likely to be satisfied with mental health services (n = 236, RR 0.24 CI 0.12 to 0.50, NNT 5 CI 5 to 8) and have improved quality of life. AUTHORS' CONCLUSIONS:Psychoeducation does seem to reduce relapse, readmission and encourage medication compliance, as well as reduce the length of hospital stay in these hospital-based studies of limited quality. The true size of effect is likely to be less than demonstrated in this review - but, nevertheless, some sort of psychoeducation could be clinically effective and potentially cost beneficial. It is not difficult to justify better, more applicable, research in this area aimed at fully investigating the effects of this promising approach.

Project description:IntroductionMetacognitive training (MCT) is a group program for improving cognitive bias in patients with schizophrenia. MCT has a reported positive effect on psychiatric symptoms and cognitive bias in patients with schizophrenia, but the effect of the intervention on patients with schizophrenia in the early recovery stage during hospitalization is not comprehensible. Therefore, this study aimed to investigate the efficacy of MCT in the early recovery stage of patients with schizophrenia in a Japanese emergency psychiatric ward.MethodThis unblinded, pilot randomized controlled trial recruited 24 patients with schizophrenia aged 20-65 years. Patients were randomly divided into two groups: occupational therapy (OT) + MCT group and OT-only group. Using the two-way repeated-measures analysis of variance (ANOVA), changes in cognitive function, psychiatric symptoms, cognitive insight, and intrinsic motivation were compared between those at baseline and post-intervention and between the two groups. Furthermore, patient readmission during the year after discharge was compared between the groups.ResultsThe final analysis included eight patients in each group, owing to the withdrawal of some patients from the study. The two-way repeated-measures analysis of variance revealed significant differences in cognitive function in several domains within subjects. However, no significant differences between subjects were observed. Psychiatric symptoms showed significant within-subject improvement, and interaction was found for general psychopathology (p = 0.03). The variable of cognitive insight and self-reflectiveness was significantly different between subjects (p = 0.03). There was no significant difference in intrinsic motivation. Readmission within a year was significantly lower in the OT + MCT group than in the OT-only group (2 [25%] vs. 6 [75%]; p = 0.046).ConclusionIn a Japanese emergency psychiatric ward, this pilot randomized controlled study was the first attempt to investigate the efficacy of MCT in patients with schizophrenia suggesting that MCT may be effective in preventing psychiatric symptoms, poor self-reflectiveness, and readmissions.The study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; UMIN000034106).

Project description:Insight is a continuous and multidimensional phenomenon, including awareness of having an illness, the presence of symptoms and accurate symptom attribution, the need for treatment, and the consequences of treatment. Good insight into illness is associated with better adherence to treatment, better cognitive, psychosocial, and vocational functioning along with less symptom severity, decreased relapses, and hospitalizations. Several tools are used for insight evaluation. We recruited 90 patients diagnosed with schizophrenia and analyzed the forms of 58 patients. The patients completed the VAGUS-SR (self-rated), Beck Cognitive Insight Scale, Knowledge About Schizophrenia Questionnaire, and Multidimensional Scale of Perceived Social Support (MSPSS). Clinicians performed a mental status examination and completed the Positive and Negative Syndrome Scale, Schedule for the Assessment of Insight, VAGUS-CR (clinician-rated), Calgary Depression Scale for Schizophrenia, and Clinical Global Impressions. We found that the level of insight evaluated using the VAGUS forms increased with knowledge regarding schizophrenia. Upon investigating the relationship between perceived social support and insight, we identified a relationship between VAGUS-CR and only significant other subscales of MSPSS, and between one of the VAGUS-SR scale sub-dimensions and significant other and total scores of MSPSS. Our findings also suggest that the VAGUS-SR and VAGUS-CR scales can be used to evaluate insight in Turkish populations. The positive relationship between perceived social support and insight emphasizes the importance of increasing social support through interventions aimed at improving insight. Our data also highlighted the value of psychoeducational studies in this patient group. Considering the multidimensional effects of insight on patients with schizophrenia, it would be beneficial to use scales such as VAGUS, which allow the insights of individuals to be evaluated in detail by both the clinician and the patient.

Project description:BackgroundEmotion dysregulation has emerged as a transdiagnostic factor that potentially exacerbates the risk of early-onset, maintenance, and relapse of psychosis. Mindfulness is described as the awareness that emerges from paying attention to the present moment without judgment. It gently pulls the mind out of the negative emotions induced by the disparity between expectation and reality by focusing on the present moment, instead of worrying about the future or regretting the past. However, only a few research has ever focused on the efficacy of using a mindfulness-based intervention to improve emotion regulation in schizophrenia spectrum disorders.PurposeThe purpose of this study was to examine the effectiveness of a Mindfulness-Based Psychoeducation Programme (MBPP) on the emotion regulation of individuals with schizophrenia, in particular, to access emotion regulation strategies. The objective of this study was to find out whether MBPP is feasible for improving emotion regulation strategies, in terms of rumination, cognitive reappraisal, and expressive suppression, with a sustainable effect at a three-month follow-up.Patients and methodsA single-blinded pilot randomised controlled trial with repeated-measures designs was adopted. Forty-six participants diagnosed with schizophrenia and its subtypes were randomised in either the 8-week mindfulness-based psychoeducation programme or treatment-as-usual (control) group.ResultsThe results of the Generalised Estimating Equations test indicated that the MBPP group showed a significant improvement in reappraisal at a three-month follow-up (β = -6.59, Wald's χ 2=4.55, p=0.033), and a significant reduction in rumination across time. However, the Generalised Estimating Equations indicated no significant difference in rumination and expressive suppression in the MBPP group. Two participants reported having unwanted experiences, including feelings of terror and distress during the mindfulness practice.ConclusionThe MBPP appeared to be effective for improving emotion regulation, which will contribute to future large-scale RCT to confirm the treatment effects in more diverse groups of schizophrenic patients.

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A pilot 1-year follow-up randomised controlled trial comparing metacognitive training to psychoeducation in schizophrenia: effects on insight.

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A pilot 1-year follow-up randomised controlled trial comparing metacognitive training to psychoeducation in schizophrenia: effects on insight.

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