<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/NCT03820362</url>
  </required_header>
  <id_info>
    <org_study_id>FPU15/01721</org_study_id>
    <nct_id>NCT03820362</nct_id>
  </id_info>
  <brief_title>The Role of Personal Identity in Psychotic Symptoms: a Study With the Repertory Grid Technique</brief_title>
  <official_title>Personal Identity, Cognitive Factors and Psychotic Symptoms in Schizophrenia and Related Disorders: A Cross-sectional Study With the Repertory Grid Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parc Sanitari Sant Joan de Déu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agència de Gestió d'Ajuts Universitaris i de Recerca, Catalunya, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministerio de Educación y Formación Profesional, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Barcelona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Personal identity is being recently recognized as a core element for mental health disorders,&#xD;
      with relevant clinical implications. However, scarcity of data exists on its role in&#xD;
      schizophrenia and related disorders. The repertory grid (RGT), a technique derived from&#xD;
      personal construct theory, has been used in different clinical and non-clinical contexts for&#xD;
      the study of the construction perception of self and others, to appreciate aspects of&#xD;
      interpersonal construing such as polarization and differentiation (unidimensional thinking)&#xD;
      or self-construction.and Our study aims to explore the potential influence of the structure&#xD;
      of personal identity and of other relevant cognitive factors (social cognition,&#xD;
      metacognition, neurocognition) in positive and negative symptoms in people suffering&#xD;
      schizophrenia and related disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over recent years, the importance of the sense of self and personal identity in&#xD;
      psychopathology and its treatment has been highlighted. Several studies inspired in the&#xD;
      Personal Construct Psychology framework have found a variety of identity characteristics in&#xD;
      clinical conditions such as depression or eating disorders, but the evidence in schizophrenia&#xD;
      and other psychotic related disorders is scarce.&#xD;
&#xD;
      In addition, current psychological models of positive and negative symptoms highlight the&#xD;
      influence of neurocognition, social cognition and self-concepts in the development and&#xD;
      maintenance of psychotic experiences. Despite the recognized need of person-centered&#xD;
      approaches to understand psychopathology processes in psychosis, psychological models for&#xD;
      explaining psychotic symptoms have not explored sufficiently the role of this kind of&#xD;
      person-centered measures.&#xD;
&#xD;
      Aim&#xD;
&#xD;
      1. To examine the influence of the structure of personal identity and other relevant&#xD;
      cognitive factors in positive and negative symptoms&#xD;
&#xD;
      Hypotheses&#xD;
&#xD;
        1. Positive symptoms will be influenced by dichotomous thinking style and construction of&#xD;
           self as measured with the RGT.&#xD;
&#xD;
        2. Negative symptoms will be affected by the richness of the construct system as measured&#xD;
           with the RGT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Self-ideal discrepancy, RGT</measure>
    <time_frame>2 hours</time_frame>
    <description>Self-esteem. Possible range: 0-0,60. Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-others discrepancy, RGT</measure>
    <time_frame>2 hours</time_frame>
    <description>Perceived social isolation. Possible range: 0-0,60. Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interpersonal construct differentiation, RGT</measure>
    <time_frame>2 hours</time_frame>
    <description>Percentage of Variance Accounted for the First Factor. Possible range: 0-100. Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Polarization, RGT</measure>
    <time_frame>2 hours</time_frame>
    <description>Dichotomous thinking style in the interpersonal context. Possible range: 0-100. Higher values represent a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of elicited constructs, RGT</measure>
    <time_frame>2 hours</time_frame>
    <description>Quantity of constructs that the person is able to express to describe self and others. Possible range: 10-50. Higher values represent a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychotic symptoms (PANSS, Kay et al. 1987; Peralta &amp; Cuesta, 1994).</measure>
    <time_frame>40 minutes</time_frame>
    <description>Positive and negative symptoms of psychosis. Range: 7-112. Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metacognition: BCIS (Beck et al. 2004; Gutiérrez-Zotes et al. 2012); Garety et al, 1991; Dudley et al, 1997)</measure>
    <time_frame>15 minutes</time_frame>
    <description>Cognitive insight. Range: 0-45. Higher values represent a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Theory of mind: the Hinting Task (Corcoran et al., 1995; Gil-Sanz et al., 2012)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Possible range: 0-12. Higher values represent a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General intellectual functioning (WAIS)</measure>
    <time_frame>20 minutes</time_frame>
    <description>vocabulary subscale. Range: 70-140. Higher values represent a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive functioning: WSCT (Bergs et al., 1948)</measure>
    <time_frame>15 minutes</time_frame>
    <description>Wisconsin Card Sorting Test. Categories completed and perseverative errors. Higher values represent a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographical data</measure>
    <time_frame>10 minutes</time_frame>
    <description>Gender, chronicity, antipsychotic dosage, diagnosis, age, marital status, education level, employment situation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>10 minutes</time_frame>
    <description>Beck Depression Inventory (Beck et al. 1996; Sanz, Perdigón &amp; Vázquez, 2003). Range_ 0-63. High values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General functioning</measure>
    <time_frame>5 minutes</time_frame>
    <description>Global Assessment of Functioning (Endicot et al., 1976). Range: 0-100. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>5 minutes</time_frame>
    <description>Rosenberg self-esteem scale (Martín Albó et al., 2007). Range: 0-40. Higher values represent a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social functioning</measure>
    <time_frame>20 minutes</time_frame>
    <description>Social Functioning Scale (Birchwood et al., 1990; Torres &amp; Olivares, 2000). Range: Range: 45-195</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological distress</measure>
    <time_frame>10 minutes</time_frame>
    <description>CORE-OM (Evans et al., 2002; Trujillo et al., 2016). Range: 0-4. Higher values represent a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jumping to Conclusions</measure>
    <time_frame>15 minutes</time_frame>
    <description>The beads task (Garety et al., 1991; Dudley et al, 1997). Dichotomous: yes/no. A &quot;yes&quot; represents a worse outcome</description>
  </secondary_outcome>
  <enrollment type="Actual">85</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Psychotic Disorders</condition>
  <condition>Self</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients recruited from the community, suffering schizophrenia and related disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of schizophrenia, psychotic disorder not otherwise specified, delusional&#xD;
             disorder, schizoaffective disorder, brief psychotic disorder, or schizophreniform&#xD;
             disorder&#xD;
&#xD;
          -  age between 18 and 60 years.&#xD;
&#xD;
          -  patients from outpatient mental health units&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  traumatic brain injury, dementia, or intellectual disability (pre-morbid IQ &lt;70)&#xD;
&#xD;
          -  current substance dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena García-Mieres, MsC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat de Barcelona &amp; Parc Sanitari Sant Joan de Déu</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susana Ochoa, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Parc Sanitari Sant Joan de Déu</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guillem Feixas, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parc Sanitary Sant Joan de Déu</name>
      <address>
        <city>Sant Boi De Llobregat</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Barcelona</investigator_affiliation>
    <investigator_full_name>Helena García Mieres</investigator_full_name>
    <investigator_title>M.Sc., Ph.D. Cand.</investigator_title>
  </responsible_party>
  <keyword>personal identity</keyword>
  <keyword>personal constructs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03820362
org study id: FPU15/01721
nct id: NCT03820362
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Personal identity is being recently recognized as a core element for mental health disorders,
      with relevant clinical implications. However, scarcity of data exists on its role in
      schizophrenia and related disorders. The repertory grid (RGT), a technique derived from
      personal construct theory, has been used in different clinical and non-clinical contexts for
      the study of the construction perception of self and others, to appreciate aspects of
      interpersonal construing such as polarization and differentiation (unidimensional thinking)
      or self-construction.and Our study aims to explore the potential influence of the structure
      of personal identity and of other relevant cognitive factors (social cognition,
      metacognition, neurocognition) in positive and negative symptoms in people suffering
      schizophrenia and related disorders.
Over recent years, the importance of the sense of self and personal identity in
      psychopathology and its treatment has been highlighted. Several studies inspired in the
      Personal Construct Psychology framework have found a variety of identity characteristics in
      clinical conditions such as depression or eating disorders, but the evidence in schizophrenia
      and other psychotic related disorders is scarce.

      In addition, current psychological models of positive and negative symptoms highlight the
      influence of neurocognition, social cognition and self-concepts in the development and
      maintenance of psychotic experiences. Despite the recognized need of person-centered
      approaches to understand psychopathology processes in psychosis, psychological models for
      explaining psychotic symptoms have not explored sufficiently the role of this kind of
      person-centered measures.

      Aim

      1. To examine the influence of the structure of personal identity and other relevant
      cognitive factors in positive and negative symptoms

      Hypotheses

        1. Positive symptoms will be influenced by dichotomous thinking style and construction of
           self as measured with the RGT.

        2. Negative symptoms will be affected by the richness of the construct system as measured
           with the RGT.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Self-ideal discrepancy, RGT
time frame: 2 hours
description: Self-esteem. Possible range: 0-0,60. Higher values represent a worse outcome
measure: Self-others discrepancy, RGT
time frame: 2 hours
description: Perceived social isolation. Possible range: 0-0,60. Higher values represent a worse outcome
measure: Interpersonal construct differentiation, RGT
time frame: 2 hours
description: Percentage of Variance Accounted for the First Factor. Possible range: 0-100. Higher values represent a worse outcome
measure: Polarization, RGT
time frame: 2 hours
description: Dichotomous thinking style in the interpersonal context. Possible range: 0-100. Higher values represent a worse outcome
measure: Number of elicited constructs, RGT
time frame: 2 hours
description: Quantity of constructs that the person is able to express to describe self and others. Possible range: 10-50. Higher values represent a better outcome
measure: Psychotic symptoms (PANSS, Kay et al. 1987; Peralta & Cuesta, 1994).
time frame: 40 minutes
description: Positive and negative symptoms of psychosis. Range: 7-112. Higher values represent a worse outcome.
measure: Metacognition: BCIS (Beck et al. 2004; Gutiérrez-Zotes et al. 2012); Garety et al, 1991; Dudley et al, 1997)
time frame: 15 minutes
description: Cognitive insight. Range: 0-45. Higher values represent a better outcome
measure: Theory of mind: the Hinting Task (Corcoran et al., 1995; Gil-Sanz et al., 2012)
time frame: 5 minutes
description: Possible range: 0-12. Higher values represent a better outcome
measure: General intellectual functioning (WAIS)
time frame: 20 minutes
description: vocabulary subscale. Range: 70-140. Higher values represent a better outcome
measure: Executive functioning: WSCT (Bergs et al., 1948)
time frame: 15 minutes
description: Wisconsin Card Sorting Test. Categories completed and perseverative errors. Higher values represent a better outcome
measure: Sociodemographical data
time frame: 10 minutes
description: Gender, chronicity, antipsychotic dosage, diagnosis, age, marital status, education level, employment situation
measure: Depressive symptoms
time frame: 10 minutes
description: Beck Depression Inventory (Beck et al. 1996; Sanz, Perdigón & Vázquez, 2003). Range_ 0-63. High values represent a worse outcome.
measure: General functioning
time frame: 5 minutes
description: Global Assessment of Functioning (Endicot et al., 1976). Range: 0-100. Higher values represent a better outcome.
measure: Self-esteem
time frame: 5 minutes
description: Rosenberg self-esteem scale (Martín Albó et al., 2007). Range: 0-40. Higher values represent a better outcome
measure: Social functioning
time frame: 20 minutes
description: Social Functioning Scale (Birchwood et al., 1990; Torres & Olivares, 2000). Range: Range: 45-195
measure: Psychological distress
time frame: 10 minutes
description: CORE-OM (Evans et al., 2002; Trujillo et al., 2016). Range: 0-4. Higher values represent a worse outcome
measure: Jumping to Conclusions
time frame: 15 minutes
description: The beads task (Garety et al., 1991; Dudley et al, 1997). Dichotomous: yes/no. A "yes" represents a worse outcome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Helena García-Mieres, MsC
role: Principal Investigator
affiliation: Universitat de Barcelona & Parc Sanitari Sant Joan de Déu
last name: Susana Ochoa, PhD
role: Study Director
affiliation: Parc Sanitari Sant Joan de Déu
last name: Guillem Feixas, PhD
role: Study Director
affiliation: University of Barcelona
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Barcelona
investigator full name: Helena García Mieres
investigator title: M.Sc., Ph.D. Cand.
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Psychotic Disorders
sharing ipd: Undecided