Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia
SCE-SCHIZO
1 other identifier
interventional
60
1 country
1
Brief Summary
This research project focuses on a fundamental element of the psychopathology of schizophrenia, that is to say, the disorders of self-awareness and on the functional alterations associated with it, that is to say, self-compassion deficit and empathy disorder. It will be a question of better understanding the neuro-functional mechanisms which underlie the lack of self-compassion and the disorder of empathy in schizophrenia, the relationship that these disorders maintain between them but also the relationship that they maintain with the general psychopathology of schizophrenia and, in particular, with the abnormalities of the self. In other words, the overall framework of this project is that of the link between the psychopathology of schizophrenia and the functional impairment associated with it. Its specific field of application is that of the link between self-awareness disorders, self-compassion deficit and empathy disorder. For this, this project proposes a methodological approach combining the recording of intrinsic and extrinsic brain activity using high-density electroencephalography (EEG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2022
CompletedFirst Submitted
Initial submission to the registry
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedAugust 20, 2024
August 1, 2024
1.8 years
April 21, 2022
August 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.
Correlation between the temporal parameters of the EEG microstates C, D, E and F (duration, contribution, occurrence) and the inter-subject correlation index during the practice of self-compassion and the practice of empathy.
through study completion, an average of 36 months.
Study Arms (2)
Patient group
EXPERIMENTALPatients have electroencephalogram records during : * a phase of rest; * a task of self-compassion * a task of empathy.
Control group
EXPERIMENTALHealthy volunteers have electroencephalogram records during : * a phase of rest; * a task of self-compassion * a task of empathy.
Interventions
An electroencephalogram is recorded during a task of rest then self-compassion and then empathy.
Eligibility Criteria
You may qualify if:
- patients with a schizophrenic or schizoaffective disorder according to the DSM-5 criteria (axis 1), with no other pathology of axis 1, except addiction to tobacco
- patients stabilized for at least 3 months for their psychotic disorders
- patients with disease duration \> 2 years but \< 20 years
- patients whose treatment has not been changed or modified in the previous month
- patients on stable treatments who should not change treatment during the study (good compliance, good tolerance)
- patients who do not benefit from a neuromodulation protocol for their symptoms (rTMS, TDCS)
- patients who do not benefit from a cognitive remediation program
- patients between the ages of 18 and 60
- men and women
- patients with normal or corrected vision
- patients without mental impairment
- patients without neurological impairment (epilepsy, encephalopathy, head trauma)
- patients with a sufficient command of French
- patients free or under protective measures
- patients benefiting from coverage by a social security scheme or benefiting from it through a third party
- +1 more criteria
You may not qualify if:
- patients with an axis 1 pathology other than a schizophrenic or schizoaffective disorder (in particular, psychic trauma revealed by MINI and symptoms of PTSD (current as lifetime))
- patients with an addiction to alcohol or other toxic substances, except tobacco
- patients with suicidal intentionality
- patients not stabilized for their psychotic disorders and with regard to their antipsychotic treatments
- patients receiving antiepileptic treatment with mood-regulating, antidepressant and anxiolytic properties
- patients receiving benzodiazepine treatment that they could not stop 72 hours before the EEG
- patients with disease duration \< 2 years or \> 20 years
- patients with an IQ \< 70
- patients benefiting from a neuromodulation protocol (rTMS, TDCS)
- patients benefiting from a cognitive remediation program
- patients with a PANSS \> or = 5 for items G8 (hostility) and P7 (non-cooperation)
- patients aged \< 18 years or \> 60 years
- patients with mental impairment
- patients with neurological impairment (epilepsy, encephalopathy, head trauma)
- patients with documented neurological pathology or medical condition that may explain the psychotic manifestations
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Henri Laborit
Poitiers, 86000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2022
First Posted
July 19, 2022
Study Start
March 22, 2022
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
August 20, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share