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

Schizophrenia Clinical Trial

— SCE-SCHIZO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464563
• Other study ID #: 2021-A01913-38
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Bérangère THIRIOUX
• Phone: +33 5 16 52 61 18
• Email: berangere.thirioux[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.