BASES: Bizarreness and Anomalous Self Experiences in Schizophrenia

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05966610
Collaborator
(none)
12
1
13.7
0.9

Study Details

Study Description

Brief Summary

Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia.

However, determining factors of this phenomena, whether cognitive or subjective, remains poorly studied.

Furthermore, Self-Disorders are alterations of the first-person experience regarded as specific of the disease. The investigators plan to study in an exploratory way the phenomenological and subjective links between Praecox Feeling and Self Disorders determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia. However, subjective, cognitive or neurophysiologic aspects of this phenomena remains poorly studied.

    Furthermore, Self-Disorders (SD) are alterations of the first-person experience and of sense of agency, regarded as specific of Schizophrenia. Unlike Praecox Feeling, clinical, cognitive and neuropsychological determinants of SD are increasingly studied.

    The investigators plan to study in an exploratory way the links between Praecox Feeling and SDs determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.

    As a secondary outcome, the investigators will control this correlation by a comparison between SDs evaluation and clinician subjectivity.

    The present study also plan to evaluate the associations between Praecox Feeling and clinical features, low and high cognitive level with attentional and social cognition evaluations.

    The first step of the research project is to implement this exploratory design in a transversal multicentric setting between centers with a limited number of participants and without follow-up.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Bizarreness and Anomalous Self Experiences in Schizophrenia: Pilot Study on Diagnostic Decision-Making
    Actual Study Start Date :
    Jul 12, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between Praecox Feeling and Self Disorders [2 months]

      Comparison between Examination of Anomalous Subjective Experience (EASE) total score evaluated at third visit and mean of Praecox Feeling intensity measured by a visual analog scale (VAS) evaluated at each visit. Examination of Anomalous Subjective Experience is a 5-item interview asked by the investigator. Visual Analog Scale (VAS) is a scale that evaluates the level of strangeness felt during the patient/investigator encounter. It goes from 0 (no strangeness feeling) to 100 (maximal strangeness feeling).

    Secondary Outcome Measures

    1. Correlation between Praecox Feeling and symptomatic dimensions [2 months]

      Comparison between mean of Praecox Feeling intensity measured by a visual analog scale evaluated at each visit and Cognition evaluation in second visit with attentional evaluation (D2-R and results at Go/No-Go testing) and social cognition evaluation (TOM-15). D2-R is a paper-and-pencil test. It's consists of the subject identifying and crossing out target characters (d with 2 lines) from a large number of characters. Go/No-Go testing is a test assesses behavioural control in a test where the participant must be able to respond to an automated external stimulus. TOM-15 consists of a false belief task and a comprehension task using the same 15 stories but different questions. The stories proposed show everyday situations. There are 8 first-order questions and 7 second-order questions, allowing two scores to be calculated, one for each order (maximum 15 in total). The more correct answers, the higher the score

    2. Correlation between Praecox Feeling intensity and Self Disorders intensity [2 months]

      Comparison between Examination of Anomalous Subjective Experience (EASE) total score a the third visit and mean of clinician subjectivity measured by Assessment of clinician's subjective experience (ACSE) at each visit. Examination of Anomalous Subjective Experience is a scale completed during the clinical interview by the investigator. It consists a 5-item scale. Assessment of clinician's subjective experience is a scale completed during the clinical interview by the investigator. It is composed of 45 items.

    3. Correlation between the patient's judgment and the quality of the meeting [2 months]

      Meeting Quality, according to the participant, evaluated at second visit in an unstructured way.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • People with a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.

    • Psychiatric medical situation judged clinically stable : no change of main antipsychotic in treatment in last 15 days.

    • People who has given his non-opposition

    • Patients affiliated to a social security system

    Exclusion Criteria:
    • Previous meeting of the participant with one of the investigators involved in the clinical assessment and scoring of the study scales.

    • Person with a moderate to severe intellectual disability (clinical criteria).

    • Person with a neurological pathology with cognitive impact

    • Patients with legal protection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Toulouse Toulouse France

    Sponsors and Collaborators

    • University Hospital, Toulouse

    Investigators

    • Principal Investigator: Tudi GOZE, MD, University Hospital, Toulouse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT05966610
    Other Study ID Numbers:
    • RC31/22/0517
    • 2023-A00049-36
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Toulouse
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2023