The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their SiblingsSTIGNCT04411797
Impact of Stigma in Siblings of Young Patients With Schizophrenic Disorders
An observational study of The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their Siblings, run by Januel.
Trial summary
Impact of stigma on the empathy and quality of life of people with schizophrenic disorders and their siblings. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their Siblings
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2020to 25 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Adult
Study population: people with schizophrenic disorders and the subjective sense of stigma and siblings of people with schizophrenic disorders
Who may be able to join
- Inclusion Criteria for the Person with Schizophrenic Disorder
- 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
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- Volunteer mastering the French language
- 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
- Criteria for non-inclusion of siblings:
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Impact of stigma on the empathy and quality of life of people with schizophrenic disorders and their siblings.
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalized Stigma of Mental Illness Scale
for people with schizophrenic disorders
Measured: 1 hour and half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start25 May 2020 (estimated)
- Primary completion25 Dec 2020 (estimated)
- Study completion25 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their SiblingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Januel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Januel, Centre hospitalier de Ville-Evrard, France
- Investigators
- Davtian Hélène, Doctor, Principal investigator, Les Funambules - Falret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411797
- Sponsor's protocol ID
- 10477M-STIG
- Acronym
- STIG
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stigma in Siblings of Young Patients With Schizophrenic Disorders
- ClinicalTrials.gov ID
- NCT04411797
- Acronym / sponsor ID
- STIG / 10477M-STIG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- JanuelUniversity, hospital or other
- Study start
- 25 May 2020 (estimated)
- Primary completion
- 25 Dec 2020 (estimated)
- Study completion
- 25 May 2022 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of stigma on the empathy and quality of life of people with schizophrenic disorders and their siblings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- people with schizophrenic disorders and the subjective sense of stigma and siblings of people with schizophrenic disorders
Key inclusion criteria (17 listed)
- Inclusion Criteria for the Person with Schizophrenic Disorder
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internalized Stigma of Mental Illness Scale
Time frame: 1 hour and half
for people with schizophrenic disorders
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davtian Hélène, Doctor principal investigator
Les Funambules - Falret
Questions about this trial
What is this clinical trial studying?
An observational study of The Impact of Stigma on the Quality of Life of People With Schizophrenic Disorders and Their Siblings, run by Januel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BENCHERIF Youcef, CRA (0143093030, y.bencherif@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalized Stigma of Mental Illness Scale (time frame: 1 hour and half). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.