NCT04411797

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Status
unknown

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

May 25, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 28, 2020

Last Update Submit

May 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Internalized Stigma of Mental Illness Scale

    for people with schizophrenic disorders

    1 hour and half

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

people with schizophrenic disorders and the subjective sense of stigma and siblings of people with schizophrenic disorders

You may qualify if:

  • Aged between 18 and 35.
  • Medical follow-up in progress
  • DSM-5 diagnosis of Schizophrenia Spectrum Disorder
  • Reading and understanding the information and non-opposition form
  • Person affiliated to a social protection scheme or beneficiary of State Medical Aid
  • Volunteer mastering the French language

You may not qualify if:

  • \. 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
  • Age of 16 years or older
  • Volunteer with a sibling included in the study with a diagnosis of schizophrenia according to DSM-5.
  • Reading and understanding the information and non-opposition form
  • Volunteer affiliated to a social protection scheme or beneficiary of State Medical Aid
  • Volunteer mastering the French language
  • Clinical condition incompatible with testing
  • Current or less than one month's commitment to another research protocol
  • Brother or sister subject to a measure of safeguard of justice 4 Brother or sister under curatorship
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Davtian Hélène, Doctor

    Les Funambules - Falret

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BENCHERIF Youcef, CRA

CONTACT

Rusheenthira THAVASEELAN, CRA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinical research unit

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 2, 2020

Study Start

May 25, 2020

Primary Completion

December 25, 2020

Study Completion

May 25, 2022

Last Updated

June 2, 2020

Record last verified: 2020-05