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Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia (SCE-SCHIZO)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Electroencephalogram

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for the patient group :

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
Having given their consent to participate in the study after having received written, clear and fair information (and after obtaining the consent of the tutor/curator if applicable)

Exclusion Criteria for the patient group :

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
patients who do not speak French well enough
subjects residing within a radius greater than 50 km from the hospital
patients hospitalized under duress
patients without social security

Inclusion Criteria for the control group:

healthy volunteers without schizophrenic or schizoaffective disorder and without other psychiatric pathologies as defined by the DSM 5 (axis 1) (in particular, absence of psychic trauma revealed by the MINI and of PTSD (current as whole life))
subjects aged 18 to 60
men and women
subjects with normal or corrected vision
subjects without mental impairment
subjects without neurological impairment (epilepsy, encephalopathy, head trauma)
free subjects, without guardianship or curatorship or subordination
subjects benefiting from coverage by a social security scheme or benefiting from it through a third party
Having given their consent to participate in the study after having received written, clear and honest information.

Exclusion Criteria for the control group:

subjects with a psychiatric pathology as defined in the DSM-5 (axis 1) (in particular, psychic trauma revealed by the MINI and symptoms of PTSD (current as lifetime))
subjects aged < 18 years or > 60 years
subjects with a mental deficiency
subjects with neurological pathology
subjects with a medical condition preventing them from participating in the study
subjects residing within a radius greater than 50 km from the hospital
subjects under guardianship or curatorship
subjects not benefiting from a Social Security scheme or not benefiting from it through a third party

Sites / Locations

Centre Hospitalier Henri LaboritRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patient group

Control group

Arm Description

Patients have electroencephalogram records during : a phase of rest; a task of self-compassion a task of empathy.

Healthy volunteers have electroencephalogram records during : a phase of rest; a task of self-compassion a task of empathy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05464563

First Posted

April 21, 2022

Last Updated

August 18, 2023

Sponsor

Centre Hospitalier Henri Laborit

1. Study Identification

Unique Protocol Identification Number

NCT05464563

Brief Title

Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia

Acronym

SCE-SCHIZO

Official Title

Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 22, 2022 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Henri Laborit

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

Detailed Description

This study includes patients (n=30) and healthy volunteers (n=30). At inclusion visit, participants have: a psychiatric evaluation; self evaluation of: empathy, self-compassion, émotionnel processing, anxiety, insight, perceptual aberration and quality of life; training to practise of self-compassion and empathy (for patients only). During the phase of experimentation, the participants have electroencephalogram exams during a rest phase, a self-compasion task and an empathy task.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient group

Arm Type

Experimental

Arm Description

Patients have electroencephalogram records during : a phase of rest; a task of self-compassion a task of empathy.

Arm Title

Control group

Arm Type

Experimental

Arm Description

Healthy volunteers have electroencephalogram records during : a phase of rest; a task of self-compassion a task of empathy.

Intervention Type

Device

Intervention Name(s)

Electroencephalogram

Intervention Description

An electroencephalogram is recorded during a task of rest then self-compassion and then empathy.

Primary Outcome Measure Information:

Title

Description

Time Frame

through study completion, an average of 36 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for the patient group : 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 Having given their consent to participate in the study after having received written, clear and fair information (and after obtaining the consent of the tutor/curator if applicable) Exclusion Criteria for the patient group : 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 patients who do not speak French well enough subjects residing within a radius greater than 50 km from the hospital patients hospitalized under duress patients without social security Inclusion Criteria for the control group: healthy volunteers without schizophrenic or schizoaffective disorder and without other psychiatric pathologies as defined by the DSM 5 (axis 1) (in particular, absence of psychic trauma revealed by the MINI and of PTSD (current as whole life)) subjects aged 18 to 60 men and women subjects with normal or corrected vision subjects without mental impairment subjects without neurological impairment (epilepsy, encephalopathy, head trauma) free subjects, without guardianship or curatorship or subordination subjects benefiting from coverage by a social security scheme or benefiting from it through a third party Having given their consent to participate in the study after having received written, clear and honest information. Exclusion Criteria for the control group: subjects with a psychiatric pathology as defined in the DSM-5 (axis 1) (in particular, psychic trauma revealed by the MINI and symptoms of PTSD (current as lifetime)) subjects aged < 18 years or > 60 years subjects with a mental deficiency subjects with neurological pathology subjects with a medical condition preventing them from participating in the study subjects residing within a radius greater than 50 km from the hospital subjects under guardianship or curatorship subjects not benefiting from a Social Security scheme or not benefiting from it through a third party

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bérangère THIRIOUX

Phone

+33 5 16 52 61 18

berangere.thirioux@ch-poitiers.fr

Facility Information:

Facility Name

Centre Hospitalier Henri Laborit

City

Poitiers

ZIP/Postal Code

86000

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia

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