Schizophrenia Clinical Trial
— METASENSOfficial title:
Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition
Metacognition is the ability to introspect and report one's own mental states, or in other words to know how much one knows. It allows us to form a sense of confidence about decisions one makes in daily life, so one can commit to one option if our confidence is high, or seek for more evidence before commitment if our confidence is low. Although this function is crucial to behave adequately in a complex environment, confidence judgments are not always optimal. Notably, individuals with schizophrenia are prone to overconfidence in errors and underconfidence in correct answers. In schizophrenia, confidence is less correlated with performance compared to controls. These aspects are held to be at the origin of delusions, disorganization, poor insight into illness and into cognitive deficit and poor social functioning. Our study aims at identifying the cognitive and neural processes involved in metacognitive deficits in schizophrenia. Participants will perform metacognitive judgments on a low-level perceptual task (visual motion discrimination). Participants will do the first-order perceptual task by clicking on the correct answer with a mouse. During the first order task completion, the investigators will record several behavioral, physiological and neural variables. Then, participants will perform the metacognitive task with a visual analog scale. The study will address four research questions: - Q1: is schizophrenia associated with a decrease in metacognitive efficiency? Is the metacognitive deficit due to under- or over-confidence? - Q2: is the metacognitive impairment reflected at a decisional level as measured by behavioral variables (mouse tracking and reaction times)? - Q3: which physiological markers (EEG, skin conductance, heart rate) are predictors of metacognitive efficiency in individuals with schizophrenia and healthy controls? - Q4: which clinical symptoms correlate with metacognitive deficits? The investigators make several hypotheses related to the previous research questions: - Q1: the investigators expect metacognitive deficits in schizophrenia, based on results from several studies using both qualitative and quantitative measures. The investigators will rule out that quantitative deficits are not confounded with impairments in type 1 performance, with a generalized cognitive deficit in schizophrenia (lower premorbid and current Intelligence Quotient (IQ), and deficits in executive functioning and particularly in planning and working memory abilities), with depression or with statistical flaws during analysis of confidence. - Q2: the investigators expect behavioral cues (mouse tracking and reaction times) to be less correlated with confidence in patients vs. controls. The investigators thus make the hypothesis that the metacognitive deficit in schizophrenia may stem from an inability to integrate pre-decisional cues while performing an explicit metacognitive judgment. - Q3: the investigators expect physiological cues (EEG with Error-Related Negativity, Lateralized Readiness Potential and alpha suppression, and arousal of the autonomic nervous system with skin conductance and heart rate ) to be less correlated with confidence in patients vs. controls. - Q4: based on previous findings, the investigators expect that several clinical dimensions of schizophrenia may correlate with metacognitive performance. The metacognitive deficit would be greater for patients with high levels of positive and disorganized symptoms, and greater for patients with low levels of clinical and cognitive insight, and low levels of social functioning.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 27, 2024 |
Est. primary completion date | July 27, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - DSM-V criteria for schizophrenia (Structured Clinical Interview for Disorders) - Normal or corrected-to-normal vision Exclusion Criteria: - a moderate or severe substance used disorder within the past 6 months (DSM-V criteria) - current or prior history of untreated significant medical illness or of neurological illness - electroconvulsive therapy in the last three months - dyschromatopsia |
Country | Name | City | State |
---|---|---|---|
France | CHU Grenoble | Grenoble | |
France | Centre Hospitalier de Versailles | Le Chesnay | |
France | CH Alpes Isère | Saint-Égrève |
Lead Sponsor | Collaborator |
---|---|
Versailles Hospital | Centre National de la Recherche Scientifique, France, Versailles Saint-Quentin-en-Yvelines University |
France,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Heart rate | Measured with a Gtec plethysmographic pulse sensor | Repeated measures within a 2 hours long experiment | |
Other | Galvanic skin response | Measured with a Gtec dedicated sensor | Repeated measures within a 2 hours long experiment | |
Primary | Metacognitive performance | Regression slope between accuracy and confidence, in a binomial mixed-effects model including appropriate covariates (variables that are significantly different between patients and controls, among the following: age, sex, education, premorbid and current IQ, executive performance with planning and working memory; and depression) | Repeated measures within a 2 hours long experiment | |
Primary | Predecisional behavioral variables | Reaction times and mouse trajectory parameters (motion entropy on the x-axis) | Repeated measures within a 2 hours long experiment | |
Primary | EEG markers | Error-Related Negativity, Lateralized Readiness Potential and alpha suppression | Repeated measures within a 2 hours long experiment | |
Secondary | Metacognitive bias | Asymptote of the regression line between accuracy and confidence, in a binomial mixed-effects model including appropriate covariates (variables that are significantly different between patients and controls, among the following: age, sex, education, premorbid and current IQ, executive performance with planning and working memory; and depression) | Repeated measures within a 2 hours long experiment | |
Secondary | Positive symptoms of schizophrenia | The following items of the the Positive and Negative Syndrome Scale: P1+P3+G9+P6+P5+G1+G12+G16-N5 | One measure per subject, assessed during a 30 min long interview | |
Secondary | Disorganization symptoms of schizophrenia | The following items of the the Positive and Negative Syndrome Scale: N7+G11+G10+P2+N5+G5 +G12 +G13 +G15+G9 | One measure per subject, assessed during a 30 min long interview | |
Secondary | Insight into illness | Total score on the Birchwood Insight Scale, a self-report scale with 8 items | One measure per subject, assessed with a 10 min long autoquestionnaire | |
Secondary | Cognitive insight | Total score on the Beck Cognitive Insight Scale, a self-report scale with 15 items | One measure per subject, assessed with a 20 min long autoquestionnaire | |
Secondary | social functioning | Total score on the Personal and Social Performance Scale | One measure per subject, assessed during a 20 min long interview |
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