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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04411797
Other study ID # 10477M-STIG
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 25, 2020
Est. completion date May 25, 2022

Study information

Verified date May 2020
Source Centre hospitalier de Ville-Evrard, France
Contact BENCHERIF Youcef, CRA
Phone 0143093030
Email y.bencherif@epsve.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Impact of stigma on the empathy and quality of life of people with schizophrenic disorders and their siblings.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 198
Est. completion date May 25, 2022
Est. primary completion date December 25, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

Inclusion Criteria for the Person with Schizophrenic Disorder

1. Aged between 18 and 35.

2. Medical follow-up in progress

3. DSM-5 diagnosis of Schizophrenia Spectrum Disorder

4. Reading and understanding the information and non-opposition form

5. Person affiliated to a social protection scheme or beneficiary of State Medical Aid

6. Volunteer mastering the French language

Exclusion Criteria:

Non-inclusion criteria for the person with schizophrenic disorders:

1. Clinical condition incompatible with testing 2. Current or less than one month's commitment to another research protocol 3. A person who is subject to a safeguard measure of justice 4 A person of full age under guardianship 5. Minor patients with mental disorders 6. Pregnant or breastfeeding women Version 1.2 date 19-05-2020 7. A person in situations of social fragility (persons deprived of liberty by a judicial or administrative decision, hospitalized persons) 8. Persons incapable or unable to give consent

Inclusion Criteria:

Inclusion criteria for a sibling member:

1. Age of 16 years or older

2. Volunteer with a sibling included in the study with a diagnosis of schizophrenia according to DSM-5.

3. Reading and understanding the information and non-opposition form

4. Volunteer affiliated to a social protection scheme or beneficiary of State Medical Aid

5. Volunteer mastering the French language

Criteria for non-inclusion of siblings:

1. Clinical condition incompatible with testing

2. Current or less than one month's commitment to another research protocol

3. Brother or sister subject to a measure of safeguard of justice 4 Brother or sister under curatorship

5. Brother or sister with mental health problems 6. Minor siblings under 16 years of age 7. A pregnant or nursing sister 8. Brother or sister in situations of social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons) 9.Brother or sister incapable or unable to give consent

Study Design


Related Conditions & MeSH terms

  • Schizophrenia
  • The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their Siblings

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Januel

Outcome

Type Measure Description Time frame Safety issue
Primary Internalized Stigma of Mental Illness Scale for people with schizophrenic disorders 1 hour and half