Abstract
BackgroundAlthough 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.MethodsThis 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.DiscussionTo 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 registrationClinicalTrials.gov: NCT04104347. Date of registration: 26/09/2019 (Retrospectively registered).
Highlights
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
Participants will be assessed at baseline (T0), following which they will be randomised to either group Metacognitive training (MCT) or a support group and they will be reassessed after treatment, i.e., at approximately 8 weeks (T1), and at 1year follow-up (T2)
Sample and eligibility criteria The sample comes from the Centro de Salud Mental de Arganzuela, which is an outpatient clinic linked with Hospital Universitario Fundación Jiménez Díaz (FJD), which provides publicly-funded medical and mental healthcare to approximately 500,000 inhabitants residing in our geographic catchment area in Madrid (Spain)
Summary
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, this remains to be established. Schizophrenia and related disorders remain associated with relatively poor psychosocial outcomes [1]. Impaired insight has been reported to be the strongest predictor of this poor outcome in psychotic disorders [2]. The effect size of previous treatments on insight. Patients with schizophrenia have been reported to show metacognitive deficits [10, 11] and poorer metacognitive performance is linked with impaired insight in schizophrenia [12]. Metacognitive training (MCT) may improve insight, which should have a positive impact on clinical outcomes
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