<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01664884</url>
  </required_header>
  <id_info>
    <org_study_id>ESTINT</org_study_id>
    <nct_id>NCT01664884</nct_id>
  </id_info>
  <brief_title>Internalized Stigma in Patients With Bipolar Disorder or Schizophrenia</brief_title>
  <acronym>ESTINT</acronym>
  <official_title>Internalized Stigma in a Sample of Young Adults With Bipolar Disorder or Schizophrenia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to explore the levels of internalized stigma in a sample of young&#xD;
      patients with bipolar disorder or schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The stigma is considered by patients, government organizations and health professionals a key&#xD;
      point in mental illness (Griffiths et al, 2006). The related literature has focused on&#xD;
      individuals with schizophrenia although there are indications that stigma act negatively in&#xD;
      patients with bipolar disorder; this, in turn, is described in a few studies, always with&#xD;
      heterogeneous samples, chronic and symptomatic patients (Perlick et al, 2001). It is also&#xD;
      known that there is a significant association between affective symptoms and the presence of&#xD;
      stigma, (Vázquez et al, 2010).&#xD;
&#xD;
      There are reports of higher levels of public stigma towards people with schizophrenia,&#xD;
      compared to patients with bipolar disorder or unipolar depression, however there are no&#xD;
      studies available on internalized stigma in such samples, especially in remitted patients .&#xD;
      Since schizophrenia coexists with significant impairment of insight, such individuals may&#xD;
      exhibit more difficulty internalizing the external bias and stereotypes. On the other hand,&#xD;
      patients with bipolar disorder - despite being less discriminated by the public in relation&#xD;
      to schizophrenia - probably have a high potential for self-stigma and its fearsome&#xD;
      consequences, justified by higher levels of insight.&#xD;
&#xD;
      The investigators would like to examine whether the lower impairment of insight in young&#xD;
      bipolar patients(in relation to young people with schizophrenia) could be accompanied by an&#xD;
      increase in internalized stigma in this sample. It´s an observational, cross-sectional study&#xD;
      with no intervention.&#xD;
&#xD;
      Hypothesis: the internalized stigma in young adults with bipolar disorder is identical to&#xD;
      that of young patients with schizophrenia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Stigma</condition>
  <arm_group>
    <arm_group_label>Bipolar Disorder Patients</arm_group_label>
    <description>Bipolar Disorder Patients, with age between 18 to 40 years old, at euthymic phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Schizophrenia Patients</arm_group_label>
    <description>Schizophrenia Patients, with age between 18 to 40 years old, with minimum or none positive symptoms.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The group will consist of patients from the Institute of Psychiatry, Hospital das Clinicas,&#xD;
        Faculty of Medicine, University of São Paulo (HCFMUSP) diagnosed by DSM-IV-TR bipolar&#xD;
        disorder (in remission) or schizophrenia (absence of positive symptoms).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of bipolar disorder and schizophrenia according to DSM-IV-TR, presenting in&#xD;
             euthymia (bipolar disorder) or without positive symptoms (schizophrenia), based on&#xD;
             clinical assessment and confirmed by structured clinical interview SCID-P&#xD;
&#xD;
          -  Age between 18 and 40 years&#xD;
&#xD;
          -  Literate and able to understand the tasks required.&#xD;
&#xD;
          -  Residents of Greater Sao Paulo.&#xD;
&#xD;
          -  Patients and / or legal representatives must understand the nature of the study and&#xD;
             sign an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Schizoaffective Disorder or Mental Retardation.&#xD;
&#xD;
          -  Unstable serious diseases including kidney disease, gastroenterology, respiratory,&#xD;
             cardiovascular, endocrine, neurological, immunological or haematological.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Alberto Moreno, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luis Felipe Oliveira Costa, M.D.</last_name>
    <phone>+551198053654</phone>
    <email>luis@costa.med.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>PROGRUDA-Institute of Psychiatry- HCFMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nayara Rodrigues, Secretary</last_name>
      <phone>+551126616648</phone>
      <email>gruda@hcnet.usp.br</email>
    </contact>
    <investigator>
      <last_name>Luis Felipe de Oliveira Costa, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 15, 2012</last_update_submitted>
  <last_update_submitted_qc>August 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Ricardo Alberto Moreno, M.D., Ph.D.</investigator_full_name>
    <investigator_title>Ricardo Alberto Moreno</investigator_title>
  </responsible_party>
  <keyword>INTERNALIZED STIGMA</keyword>
  <keyword>INSIGHT</keyword>
  <keyword>SOCIAL ADEQUACY</keyword>
  <keyword>BIPOLAR DISORDER</keyword>
  <keyword>SCHIZOPHRENIA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01664884
org study id: ESTINT
nct id: NCT01664884
lead sponsor: 
has dmc: No
The aim of this study is to explore the levels of internalized stigma in a sample of young
      patients with bipolar disorder or schizophrenia.
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.
observational model: Ecologic or Community
time perspective: Cross-Sectional
arm group label: Bipolar Disorder Patients
description: Bipolar Disorder Patients, with age between 18 to 40 years old, at euthymic phase.
arm group label: Schizophrenia Patients
description: Schizophrenia Patients, with age between 18 to 40 years old, with minimum or none positive symptoms.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ricardo Alberto Moreno, MD PhD
role: Study Director
affiliation: University of Sao Paulo
last name: Luis Felipe Oliveira Costa, M.D.
phone: +551198053654
email: luis@costa.med.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Ricardo Alberto Moreno, M.D., Ph.D.
investigator title: Ricardo Alberto Moreno
mesh term: Schizophrenia
mesh term: Bipolar Disorder