StigmaESTINTNCT01664884
Internalized Stigma in Patients With Bipolar Disorder or Schizophrenia
An observational study of Stigma, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to explore the levels of internalized stigma in a sample of young patients with bipolar disorder or schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Stigma
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Jan 2013
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: The group will consist of patients from the Institute of Psychiatry, Hospital das Clinicas, Faculty of Medicine, University of São Paulo (HCFMUSP) diagnosed by DSM-IV-TR bipolar disorder (in remission) or schizophrenia (absence of positive symptoms).
Who may be able to join
- Diagnosis of bipolar disorder and schizophrenia according to DSM-IV-TR, presenting in euthymia (bipolar disorder) or without positive symptoms (schizophrenia), based on clinical assessment and confirmed by structured clinical interview SCID-P
- Age between 18 and 40 years
- Literate and able to understand the tasks required.
- Residents of Greater Sao Paulo.
- Patients and / or legal representatives must understand the nature of the study and sign an informed consent.
Who cannot join
- Patients with Schizoaffective Disorder or Mental Retardation.
- Unstable serious diseases including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
PROGRUDA-Institute of Psychiatry- HCFMUSP
São Paulo, São Paulo
Nayara Rodrigues, Secretary, +551126616648, gruda@hcnet.usp.br
Luis Felipe de Oliveira Costa, MD
About this study
Official title: Internalized Stigma in a Sample of Young Adults With Bipolar Disorder or Schizophrenia.
The aim of this study is to explore the levels of internalized stigma in a sample of young patients with bipolar disorder or schizophrenia.
Read the detailed description
The stigma is considered by patients, government organizations and health professionals a key point in mental illness (Griffiths et al, 2006). The related literature has focused on individuals with schizophrenia although there are indications that stigma act negatively in patients with bipolar disorder; this, in turn, is described in a few studies, always with heterogeneous samples, chronic and symptomatic patients (Perlick et al, 2001). It is also known that there is a significant association between affective symptoms and the presence of stigma, (Vázquez et al, 2010).
There are reports of higher levels of public stigma towards people with schizophrenia, compared to patients with bipolar disorder or unipolar depression, however there are no studies available on internalized stigma in such samples, especially in remitted patients . Since schizophrenia coexists with significant impairment of insight, such individuals may exhibit more difficulty internalizing the external bias and stereotypes. On the other hand, patients with bipolar disorder - despite being less discriminated by the public in relation to schizophrenia - probably have a high potential for self-stigma and its fearsome consequences, justified by higher levels of insight.
The investigators would like to examine whether the lower impairment of insight in young bipolar patients(in relation to young people with schizophrenia) could be accompanied by an increase in internalized stigma in this sample. It´s an observational, cross-sectional study with no intervention.
Hypothesis: the internalized stigma in young adults with bipolar disorder is identical to that of young patients with schizophrenia.
- Conditions
- Stigma
- Keywords
- INTERNALIZED STIGMA, INSIGHT, SOCIAL ADEQUACY, BIPOLAR DISORDER, SCHIZOPHRENIA
- Medical subject headings
- Social Stigma, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder Patients | Bipolar Disorder Patients, with age between 18 to 40 years old, at euthymic phase. | |
| Schizophrenia Patients | Schizophrenia Patients, with age between 18 to 40 years old, with minimum or none positive symptoms. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StigmaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo
- Investigators
- Ricardo Alberto Moreno, MD PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664884
- Sponsor's protocol ID
- ESTINT
- Acronym
- ESTINT
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internalized Stigma in a Sample of Young Adults With Bipolar Disorder or Schizophrenia.
- ClinicalTrials.gov ID
- NCT01664884
- Acronym / sponsor ID
- ESTINT / ESTINT
- Conditions
- Stigma
- Keywords
- INTERNALIZED STIGMA, INSIGHT, SOCIAL ADEQUACY, BIPOLAR DISORDER, SCHIZOPHRENIA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 14 Aug 2012 (estimated)
- 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.
The aim of this study is to explore the levels of internalized stigma in a sample of young patients with bipolar disorder or schizophrenia.
Detailed description
The stigma is considered by patients, government organizations and health professionals a key point in mental illness (Griffiths et al, 2006). The related literature has focused on individuals with schizophrenia although there are indications that stigma act negatively in patients with bipolar disorder; this, in turn, is described in a few studies, always with heterogeneous samples, chronic and symptomatic patients (Perlick et al, 2001). It is also known that there is a significant association between affective symptoms and the presence of stigma, (Vázquez et al, 2010).
There are reports of higher levels of public stigma towards people with schizophrenia, compared to patients with bipolar disorder or unipolar depression, however there are no studies available on internalized stigma in such samples, especially in remitted patients . Since schizophrenia coexists with significant impairment of insight, such individuals may exhibit more difficulty internalizing the external bias and stereotypes. On the other hand, patients with bipolar disorder - despite being less discriminated by the public in relation to schizophrenia - probably have a high potential for self-stigma and its fearsome consequences, justified by higher levels of insight.
The investigators would like to examine whether the lower impairment of insight in young bipolar patients(in relation to young people with schizophrenia) could be accompanied by an increase in internalized stigma in this sample. It´s an observational, cross-sectional study with no intervention.
Hypothesis: the internalized stigma in young adults with bipolar disorder is identical to that of young patients with schizophrenia.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder Patients | – | –Bipolar Disorder Patients, with age between 18 to 40 years old, at euthymic phase. |
| Schizophrenia Patients | – | –Schizophrenia Patients, with age between 18 to 40 years old, with minimum or none positive symptoms. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The group will consist of patients from the Institute of Psychiatry, Hospital das Clinicas, Faculty of Medicine, University of São Paulo (HCFMUSP) diagnosed by DSM-IV-TR bipolar disorder (in remission) or schizophrenia (absence of positive symptoms).
Key inclusion criteria (5 listed)
- Diagnosis of bipolar disorder and schizophrenia according to DSM-IV-TR, presenting in euthymia (bipolar disorder) or without positive symptoms (schizophrenia), based on clinical assessment and confirmed by structured clinical interview SCID-P
- Age between 18 and 40 years
- Literate and able to understand the tasks required.
- Residents of Greater Sao Paulo.
- Patients and / or legal representatives must understand the nature of the study and sign an informed consent.
Key exclusion criteria (2 listed)
- Patients with Schizoaffective Disorder or Mental Retardation.
- Unstable serious diseases including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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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.
Ricardo Alberto Moreno, MD PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stigma, run by University of Sao Paulo at 1 site in Brazil.
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 5 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 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Luis Felipe Oliveira Costa, M.D. (+551198053654, luis@costa.med.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 16 Aug 2012.