<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/NCT04481217</url>
  </required_header>
  <id_info>
    <org_study_id>38RC20.055</org_study_id>
    <secondary_id>2020-A00452-37</secondary_id>
    <nct_id>NCT04481217</nct_id>
  </id_info>
  <brief_title>Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia</brief_title>
  <acronym>HADITRYOS</acronym>
  <official_title>The Mediating Role of Dissociative Symptoms and Early Maladaptive Schemas in the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</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>
      BACKGROUND It is demonstrated that strong associations between trauma suffered in childhood&#xD;
      and having schizophrenia, and more specifically to experience acoustic-verbal hallucinations&#xD;
      (AVH). A second generation of research is currently examining the cognitive and affective&#xD;
      processes likely to play a mediating role in this association. These mediators appear to&#xD;
      include early maladaptive personality patterns and dissociative experiences. Although these&#xD;
      factors have most often been explored separately, recent research indicates that they could&#xD;
      be associated, and thus contribute to AVH. More specifically, another study has shown that&#xD;
      the association between childhood trauma and predisposition to AVH is not direct but depends&#xD;
      on cognitive factors including the impact of violence suffered during childhood on early&#xD;
      maladaptive schemas and dissociation. However, this study was carried out on a non-clinical&#xD;
      sample of subjects with a predisposition to AVH.&#xD;
&#xD;
      OBJECTIVES: testing a structural model of AVH, childhood trauma, early maladaptive schemas&#xD;
      and dissociative symptoms in large multicentric sample of inpatients diagnosed with&#xD;
      schizophrenia and AVH (n=350). Secondary objectives are (i) test in the model the role of all&#xD;
      the early patterns described by Jeffrey Young instead of targeting only the schemes that are&#xD;
      part of the model tested in previous study as the one by Bortolon and colleagues, (ii)&#xD;
      compare the quality of the adjustment of the confirmatory model to the quality of the&#xD;
      adjustment of the exploratory model.&#xD;
&#xD;
      METHODS: one single visit in which subjects will receive self-reported questionnaires&#xD;
      (Childhood trauma questionnaire, The Young schema questionnaire short form, Dissociative&#xD;
      experiences scale, Launay-Slade hallucination scale and Cardiff Anomalous Perceptions Scale.&#xD;
&#xD;
      ANALYSES: Structural equation model performed additional analysis using Partial Least Squares&#xD;
      Structural Equation Modelling. The primary endpoint corresponds to significant associations&#xD;
      between the variables. The quality of the model will be assessed using a fit quality measure.&#xD;
      The secondary endpoints are significant associations between the different variables (p&#xD;
      &lt;0.05) and the model quality assessed with a quality measure of the fit.&#xD;
&#xD;
      MAIN HYPOTHESIS: the association between childhood trauma and predisposition to AVH is not&#xD;
      direct, but depends on the impact of violence suffered during childhood on early maladaptive&#xD;
      schemas and dissociative symptoms in patients with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND A first generation of research has demonstrated strong associations between trauma&#xD;
      suffered in childhood (physical, psychological and sexual violence) and having schizophrenia,&#xD;
      and more specifically to experience &quot;hearing voices&quot; (acoustic-verbal hallucinations, AVH).&#xD;
&#xD;
      A second generation of research is currently examining the cognitive and affective processes&#xD;
      likely to play a mediating role in this association. These mediators appear to include early&#xD;
      maladaptive personality patterns and dissociative experiences. Although these factors have&#xD;
      most often been explored separately, recent research indicates that they could be associated,&#xD;
      and thus contribute to AVH. More specifically, another study has shown that the association&#xD;
      between childhood trauma and predisposition to AVH is not direct but depends on cognitive&#xD;
      factors including the impact of violence suffered during childhood on early maladaptive&#xD;
      schemas (for example, interpersonal functioning centred on &quot;subjugation&quot;, &quot;abandonment&quot;,&#xD;
      &quot;vulnerability&quot;) and dissociation. However, this study was carried out on a non-clinical&#xD;
      sample of subjects with a predisposition to AVH OBJECTIVES Here, aim is at testing a&#xD;
      structural model of AVH, childhood trauma, early maladaptive schemas and dissociative&#xD;
      symptoms in large sample of patients diagnosed with schizophrenia and AVH (n=350).&#xD;
&#xD;
      Secondary objectives are (i) to carry out exploratory analyzes which will allow investigators&#xD;
      to test in the model the role of all the early patterns described by Jeffrey Young instead of&#xD;
      targeting only the schemes that are part of the model tested in previous study as the one by&#xD;
      Bortolon and colleagues, (ii) compare the quality of the adjustment of the confirmatory model&#xD;
      to the quality of the adjustment of the exploratory model.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      A cross-sectional, multicenter design (3 centres) will be performed. Patients included will&#xD;
      be diagnosed with schizophrenia or schizoaffective disorder, and experience AVH at the time&#xD;
      of the inclusion (n= 350). All will be inpatients. The study consists of one single visit in&#xD;
      which the subjects will receive all the self-reported questionnaires to be completed:&#xD;
&#xD;
        1. General information sheet (socio-demographic and clinical data)&#xD;
&#xD;
        2. Questionnaire on traumatic childhood experiences: Childhood trauma questionnaire&#xD;
&#xD;
        3. Questionnaire on early maladaptive schemas: The Young schema questionnaire short form&#xD;
&#xD;
        4. Questionnaire about dissociative experiences: Dissociative experiences scale&#xD;
&#xD;
        5. Questionnaire on hallucinations: Launay - Slade hallucination scale and Cardiff&#xD;
           Anomalous Perceptions Scale.&#xD;
&#xD;
      All questionnaires have been validated in French. ANALYSES Structural equation model&#xD;
      performed additional analysis using Partial Least Squares Structural Equation Modelling&#xD;
      (PLS-SEM).&#xD;
&#xD;
      The primary endpoint corresponds to significant associations (significance threshold &lt;0.05)&#xD;
      between the variables as in the model described by Bortolon and colleagues. The quality of&#xD;
      the model (both measurement and structural model) will be assessed using a fit quality&#xD;
      measure.&#xD;
&#xD;
      The secondary endpoints are significant associations between the different variables (p&#xD;
      &lt;0.05) and the model quality assessed with a quality measure of the fit.&#xD;
&#xD;
      HYPOTHESES It's hypothesized that the association between childhood trauma and predisposition&#xD;
      to AVH is not direct, but depends on the impact of violence suffered during childhood on&#xD;
      early maladaptive schemas (for example, interpersonal functioning centred on &quot;subjugation&quot;,&#xD;
      &quot;abandonment&quot;, &quot;vulnerability&quot;) and dissociative symptoms in patients with schizophrenia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Auditory hallucinations measured by the Launay-Slade Hallucination Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>The auditory hallucinations measured by the Launay-Slade Hallucination Scale, which is a self-report scale developed to measure predisposition to hallucinations.&#xD;
Three items were designed to measure verbal hallucinations, which are measured using a 5-point Likert scale, from 0 to 4 (0 = &quot;definitely does not apply to me,&quot; 1 = &quot;possibly does not apply to me,&quot; 2 = &quot;unsure,&quot; 3 = &quot;possibly applies to me,&quot; and 4 = &quot;definitely applies to me&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Defensive dissociation assessed by the Dissociative experiences scale (DES)</measure>
    <time_frame>Baseline</time_frame>
    <description>Defensive dissociation assessed by the Dissociative experiences scale (DES). The DES is a 28-item developed to measure dissociative experiences. Respondents are asked to rate how often they experienced each of the 28 described situation compared to other people. The scale was composed of 11 boxes that the participants had to tick (from &quot;much less than others&quot; to &quot;much more than others&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early maladaptive schema &quot;Abandonment&quot;, which is measured by the young schema questionnaire short form (SQ-SF)</measure>
    <time_frame>Baseline</time_frame>
    <description>The early maladaptive schema &quot;Abandonment&quot;, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = &quot;completely untrue of me&quot; to 6 = &quot;describes me perfectly&quot;). Higher scores indicate a greater presence of a maladaptive schema for the respondent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The early maladaptive schema &quot;Self-sacrifice&quot;, which is measured by the young schema questionnaire short form (SQ-SF)</measure>
    <time_frame>Baseline</time_frame>
    <description>The early maladaptive schema &quot;Self-sacrifice&quot;, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = &quot;completely untrue of me&quot; to 6 = &quot;describes me perfectly&quot;). Higher scores indicate a greater presence of a maladaptive schema for the respondent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The early maladaptive schema &quot;Vulnerability&quot;, which is measured by the young schema questionnaire short form (SQ-SF)</measure>
    <time_frame>Baseline</time_frame>
    <description>The early maladaptive schema &quot;Vulnerability&quot;, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = &quot;completely untrue of me&quot; to 6 = &quot;describes me perfectly&quot;). Higher scores indicate a greater presence of a maladaptive schema for the respondent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The early maladaptive schema &quot;Subjugation&quot;, which is measured by the young schema questionnaire short form (SQ-SF)</measure>
    <time_frame>Baseline</time_frame>
    <description>The early maladaptive schema &quot;Subjugation&quot;, which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = &quot;completely untrue of me&quot; to 6 = &quot;describes me perfectly&quot;). Higher scores indicate a greater presence of a maladaptive schema for the respondent.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Schizophrenia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients included will be diagnosed with schizophrenia or schizoaffective disorder, and experience AVH at the time of the inclusion (n= 350). All will be inpatients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-questionnaires battery</intervention_name>
    <description>Childhood trauma questionnaire (Bernstein, Ahluvalia, Pogge, &amp; Handelsman, 1997; Bernstein et al., 2003)&#xD;
The Young schema questionnaire short form (SQ-SF ; Cottraux &amp; Black, 2006; Young, 1998).&#xD;
Dissociative experiences scale (Laroi et al., 2013).&#xD;
Launay-Slade hallucination scale (Bentall &amp; Slade, 1985; Launay &amp; Slade, 1981)&#xD;
Cardiff Anomalous Perceptions Scale (Bell et al., 2006)</description>
    <arm_group_label>Schizophrenia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Socio-demographic screening</intervention_name>
    <description>age; gender; education; highest diploma; job; marital status; living place</description>
    <arm_group_label>Schizophrenia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Schizophrenia or schizo-affective disorder&#xD;
&#xD;
          -  Auditory hallucinations&#xD;
&#xD;
          -  Fluent in French&#xD;
&#xD;
          -  Gave informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Agitation or suicide risk&#xD;
&#xD;
          -  Involuntary Hospitalization&#xD;
&#xD;
          -  Neurologic condition&#xD;
&#xD;
          -  No informed consent&#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>Clément DONDE</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Grenoble Alpes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clément DONDE</last_name>
    <phone>+33 (0)4 76 76 39 86</phone>
    <email>cdondecoquelet@chu-grenoble.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Grenoble University Hospital</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clément DONDÉ, MD PhD</last_name>
      <email>cdondecoquelet@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu St Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric FAKRA, Pr</last_name>
      <phone>+33 (0)4 77 82 88 52</phone>
      <email>Eric.Fakra@chu-st-etienne.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>auditory verbal hallucinations</keyword>
  <keyword>early maladaptive schemas</keyword>
  <keyword>dissociative symptoms</keyword>
  <keyword>childhood traumas</keyword>
  <keyword>mediation modeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallucinations</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04481217
org study id: 38RC20.055
secondary id: 2020-A00452-37
nct id: NCT04481217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND It is demonstrated that strong associations between trauma suffered in childhood
      and having schizophrenia, and more specifically to experience acoustic-verbal hallucinations
      (AVH). A second generation of research is currently examining the cognitive and affective
      processes likely to play a mediating role in this association. These mediators appear to
      include early maladaptive personality patterns and dissociative experiences. Although these
      factors have most often been explored separately, recent research indicates that they could
      be associated, and thus contribute to AVH. More specifically, another study has shown that
      the association between childhood trauma and predisposition to AVH is not direct but depends
      on cognitive factors including the impact of violence suffered during childhood on early
      maladaptive schemas and dissociation. However, this study was carried out on a non-clinical
      sample of subjects with a predisposition to AVH.

      OBJECTIVES: testing a structural model of AVH, childhood trauma, early maladaptive schemas
      and dissociative symptoms in large multicentric sample of inpatients diagnosed with
      schizophrenia and AVH (n=350). Secondary objectives are (i) test in the model the role of all
      the early patterns described by Jeffrey Young instead of targeting only the schemes that are
      part of the model tested in previous study as the one by Bortolon and colleagues, (ii)
      compare the quality of the adjustment of the confirmatory model to the quality of the
      adjustment of the exploratory model.

      METHODS: one single visit in which subjects will receive self-reported questionnaires
      (Childhood trauma questionnaire, The Young schema questionnaire short form, Dissociative
      experiences scale, Launay-Slade hallucination scale and Cardiff Anomalous Perceptions Scale.

      ANALYSES: Structural equation model performed additional analysis using Partial Least Squares
      Structural Equation Modelling. The primary endpoint corresponds to significant associations
      between the variables. The quality of the model will be assessed using a fit quality measure.
      The secondary endpoints are significant associations between the different variables (p
      <0.05) and the model quality assessed with a quality measure of the fit.

      MAIN HYPOTHESIS: the association between childhood trauma and predisposition to AVH is not
      direct, but depends on the impact of violence suffered during childhood on early maladaptive
      schemas and dissociative symptoms in patients with schizophrenia.
BACKGROUND A first generation of research has demonstrated strong associations between trauma
      suffered in childhood (physical, psychological and sexual violence) and having schizophrenia,
      and more specifically to experience "hearing voices" (acoustic-verbal hallucinations, AVH).

      A second generation of research is currently examining the cognitive and affective processes
      likely to play a mediating role in this association. These mediators appear to include early
      maladaptive personality patterns and dissociative experiences. Although these factors have
      most often been explored separately, recent research indicates that they could be associated,
      and thus contribute to AVH. More specifically, another study has shown that the association
      between childhood trauma and predisposition to AVH is not direct but depends on cognitive
      factors including the impact of violence suffered during childhood on early maladaptive
      schemas (for example, interpersonal functioning centred on "subjugation", "abandonment",
      "vulnerability") and dissociation. However, this study was carried out on a non-clinical
      sample of subjects with a predisposition to AVH OBJECTIVES Here, aim is at testing a
      structural model of AVH, childhood trauma, early maladaptive schemas and dissociative
      symptoms in large sample of patients diagnosed with schizophrenia and AVH (n=350).

      Secondary objectives are (i) to carry out exploratory analyzes which will allow investigators
      to test in the model the role of all the early patterns described by Jeffrey Young instead of
      targeting only the schemes that are part of the model tested in previous study as the one by
      Bortolon and colleagues, (ii) compare the quality of the adjustment of the confirmatory model
      to the quality of the adjustment of the exploratory model.

      METHODS

      A cross-sectional, multicenter design (3 centres) will be performed. Patients included will
      be diagnosed with schizophrenia or schizoaffective disorder, and experience AVH at the time
      of the inclusion (n= 350). All will be inpatients. The study consists of one single visit in
      which the subjects will receive all the self-reported questionnaires to be completed:

        1. General information sheet (socio-demographic and clinical data)

        2. Questionnaire on traumatic childhood experiences: Childhood trauma questionnaire

        3. Questionnaire on early maladaptive schemas: The Young schema questionnaire short form

        4. Questionnaire about dissociative experiences: Dissociative experiences scale

        5. Questionnaire on hallucinations: Launay - Slade hallucination scale and Cardiff
           Anomalous Perceptions Scale.

      All questionnaires have been validated in French. ANALYSES Structural equation model
      performed additional analysis using Partial Least Squares Structural Equation Modelling
      (PLS-SEM).

      The primary endpoint corresponds to significant associations (significance threshold <0.05)
      between the variables as in the model described by Bortolon and colleagues. The quality of
      the model (both measurement and structural model) will be assessed using a fit quality
      measure.

      The secondary endpoints are significant associations between the different variables (p
      <0.05) and the model quality assessed with a quality measure of the fit.

      HYPOTHESES It's hypothesized that the association between childhood trauma and predisposition
      to AVH is not direct, but depends on the impact of violence suffered during childhood on
      early maladaptive schemas (for example, interpersonal functioning centred on "subjugation",
      "abandonment", "vulnerability") and dissociative symptoms in patients with schizophrenia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Auditory hallucinations measured by the Launay-Slade Hallucination Scale
time frame: Baseline
description: The auditory hallucinations measured by the Launay-Slade Hallucination Scale, which is a self-report scale developed to measure predisposition to hallucinations.
Three items were designed to measure verbal hallucinations, which are measured using a 5-point Likert scale, from 0 to 4 (0 = "definitely does not apply to me," 1 = "possibly does not apply to me," 2 = "unsure," 3 = "possibly applies to me," and 4 = "definitely applies to me").
measure: Defensive dissociation assessed by the Dissociative experiences scale (DES)
time frame: Baseline
description: Defensive dissociation assessed by the Dissociative experiences scale (DES). The DES is a 28-item developed to measure dissociative experiences. Respondents are asked to rate how often they experienced each of the 28 described situation compared to other people. The scale was composed of 11 boxes that the participants had to tick (from "much less than others" to "much more than others").
measure: Early maladaptive schema "Abandonment", which is measured by the young schema questionnaire short form (SQ-SF)
time frame: Baseline
description: The early maladaptive schema "Abandonment", which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = "completely untrue of me" to 6 = "describes me perfectly"). Higher scores indicate a greater presence of a maladaptive schema for the respondent.
measure: The early maladaptive schema "Self-sacrifice", which is measured by the young schema questionnaire short form (SQ-SF)
time frame: Baseline
description: The early maladaptive schema "Self-sacrifice", which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = "completely untrue of me" to 6 = "describes me perfectly"). Higher scores indicate a greater presence of a maladaptive schema for the respondent.
measure: The early maladaptive schema "Vulnerability", which is measured by the young schema questionnaire short form (SQ-SF)
time frame: Baseline
description: The early maladaptive schema "Vulnerability", which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = "completely untrue of me" to 6 = "describes me perfectly"). Higher scores indicate a greater presence of a maladaptive schema for the respondent.
measure: The early maladaptive schema "Subjugation", which is measured by the young schema questionnaire short form (SQ-SF)
time frame: Baseline
description: The early maladaptive schema "Subjugation", which is measured by the young schema questionnaire short form (SQ-SF). The SQ-SF is a 75-item, self-report inventory designed to measure 15 EMS proposed by Young. Each item is rated on a 6-point scale (from 1 = "completely untrue of me" to 6 = "describes me perfectly"). Higher scores indicate a greater presence of a maladaptive schema for the respondent.
arm group label: Schizophrenia
arm group type: Experimental
description: Patients included will be diagnosed with schizophrenia or schizoaffective disorder, and experience AVH at the time of the inclusion (n= 350). All will be inpatients.
intervention type: Other
intervention name: Self-questionnaires battery
description: Childhood trauma questionnaire (Bernstein, Ahluvalia, Pogge, & Handelsman, 1997; Bernstein et al., 2003)
The Young schema questionnaire short form (SQ-SF ; Cottraux & Black, 2006; Young, 1998).
Dissociative experiences scale (Laroi et al., 2013).
Launay-Slade hallucination scale (Bentall & Slade, 1985; Launay & Slade, 1981)
Cardiff Anomalous Perceptions Scale (Bell et al., 2006)
arm group label: Schizophrenia
intervention type: Other
intervention name: Socio-demographic screening
description: age; gender; education; highest diploma; job; marital status; living place
arm group label: Schizophrenia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Clément DONDE
role: Principal Investigator
affiliation: CHU Grenoble Alpes
last name: Clément DONDE
phone: +33 (0)4 76 76 39 86
email: cdondecoquelet@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
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responsible party type: Sponsor
mesh term: Hallucinations
mesh term: Schizophrenia
sharing ipd: No