Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition

NCT03140475 | Completed

• 2 other identifiers: P16/25_METASENS/METACTION2016-A01612-49
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Schizophrenia; Insight Impaired; Social Skills; Behavior

Keywords

Metacognition; Mousetracking; EEG; Event related potentials; Frequency analysis; Depression

Outcome Measures

Primary Outcomes (3)

• 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

• Predecisional behavioral variables

  Reaction times and mouse trajectory parameters (motion entropy on the x-axis)

  Repeated measures within a 2 hours long experiment

• EEG markers

  Error-Related Negativity, Lateralized Readiness Potential and alpha suppression

  Repeated measures within a 2 hours long experiment

Secondary Outcomes (6)

• Metacognitive bias

  Repeated measures within a 2 hours long experiment

• Positive symptoms of schizophrenia

  One measure per subject, assessed during a 30 min long interview

• Disorganization symptoms of schizophrenia

  One measure per subject, assessed during a 30 min long interview

• Insight into illness

  One measure per subject, assessed with a 10 min long autoquestionnaire

• Cognitive insight

  One measure per subject, assessed with a 20 min long autoquestionnaire

Other Outcomes (2)

• Heart rate

  Repeated measures within a 2 hours long experiment

• Galvanic skin response

  Repeated measures within a 2 hours long experiment

Study Arms (2)

Individuals with schizophrenia

Behavioral variables: Type 1 task (motion discrimination) accuracy (binary: correct/incorrect) / Type 1 reaction time (continuous: time to respond to the type 1 task in ms) / Confidence (continuous: visual analog scale) / Type 2 reaction time (continuous: time to report confidence in ms) / Mouse trajectory (pixel coordinates) Physiological variables: Electroencephalogram (continuous: 64ch. time-locked to type 1 response) / Heart rate (continuous: time-locked to type 1 response) / Galvanic skin response (continuous: time-locked to type 1 response) Clinical variables: Positive and Negative Syndrome Scale / Birchwood Insight Scale / Beck Cognitive Insight Scale / Personal and Social Performance Scale / Calgary Depression Scale / Chlorpromazine equivalents Neuropsychological variables: National Adult Reading Test (French) / Wechsler Adult Intelligence Scale version IV (WAIS-IV) subtests (matrix reasoning, vocabulary, letter-number sequencing)

Controls

Behavioral variables: Type 1 task (motion discrimination) accuracy (binary: correct/incorrect) / Type 1 reaction time (continuous: time to respond to the type 1 task in ms) / Confidence (continuous: visual analog scale) / Type 2 reaction time (continuous: time to report confidence in ms) / Mouse trajectory (pixel coordinates) / Physiological variables: Electroencephalogram (continuous: 64ch. time-locked to type 1 response) / Heart rate (continuous: time-locked to type 1 response) / Galvanic skin response (continuous: time-locked to type 1 response) / Clinical variables: Calgary Depression Scale Neuropsychological variables: National Adult Reading Test (French) / WAIS-IV subtests (matrix reasoning, vocabulary, letter-number sequencing)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients: Patients will be stabilized and will be recruited from community mental health centers and outpatient clinics in the Versailles area and among the FACE-SZ (FondaMental Academic Centers of Expertise for Schizophrenia) cohort in Versailles. Controls: Healthy volunteers will be recruited from the general population. The control group will be screened for current or past psychiatric illness and participants will be excluded if they meet criteria for any disorder of the DSM-V All participants will be naive to the purpose of the study, give informed consent in accordance with institutional guidelines and the Declaration of Helsinki, and receive a monetary compensation (10€ / h).

You may qualify if:

• DSM-V criteria for schizophrenia (Structured Clinical Interview for Disorders)
• Normal or corrected-to-normal vision

You may not qualify if:

• 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

Sponsors & Collaborators

• Versailles Hospital: lead
• Versailles Saint-Quentin-en-Yvelines University: collaborator
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (3)

CHU Grenoble

Grenoble, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

CH Alpes Isère

Saint-Égrève, France

Location

Related Publications (29)

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MeSH Terms

Conditions

Schizophrenia; Social Skills; Behavior; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavioral Symptoms

Study Officials

• Paul ROUX, MD PhD

  Versailles Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: April 27, 2017
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)