<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/NCT02976077</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01271-50</org_study_id>
    <nct_id>NCT02976077</nct_id>
  </id_info>
  <brief_title>RC2S+: Remediation of Social Cognitive Impairments</brief_title>
  <acronym>RC2S+</acronym>
  <official_title>Preliminary Validation of the RC2S+ Therapy in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital le Vinatier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital le Vinatier</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Difficulties in social interactions are a central characteristic of people with&#xD;
      schizophrenia, and can be partly explained by impairments of social cognitive processes.&#xD;
      According to renown researchers, three to five social cognitive processes are usually altered&#xD;
      in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional&#xD;
      style; and (4 and 5) social perception and knowledge. The components of social cognition&#xD;
      appear to be related to both symptomatology and functioning in everyday life.&#xD;
&#xD;
      New strategies of cognitive remediation have been recently developed to target these deficits&#xD;
      and few meta analyses have assessed the extent to which social cognitive remediation programs&#xD;
      have led to multiple improvements for schizophrenia patients. Overall, it seems that such&#xD;
      therapies showed encouraging results in both patient interest and motivation, and social&#xD;
      cognitive processes.&#xD;
&#xD;
      The RC2S therapy is the first individualized and partly computerized program through which&#xD;
      patients practice social interactions and develop social cognitive abilities with simulation&#xD;
      techniques in a realistic environment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods:&#xD;
&#xD;
      This is a randomized controlled trial to establish the validity of the RC2S+ program in&#xD;
      schizophrenia.&#xD;
&#xD;
      The project's main objective is to assess the impact of RC2S+ on social cognitive impairments&#xD;
      in schizophrenia compared with a cognitive remediation program (control therapy) focusing on&#xD;
      neurocognition, equivalent in terms of number, duration and rhythm of sessions.&#xD;
&#xD;
      The study has four other objectives:&#xD;
&#xD;
        1. To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive&#xD;
           processes&#xD;
&#xD;
        2. To assess the impact of the RC2S+ therapy versus control therapy on social functioning&#xD;
&#xD;
        3. To assess the impact of the RC2S+ therapy versus control therapy on both positive and&#xD;
           negative symptoms&#xD;
&#xD;
        4. To study the maintenance of benefits 3 months forward&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      To treat social cognitive impairments in people with schizophrenia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2016</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the HB (Hostility Bias) score</measure>
    <time_frame>week 12</time_frame>
    <description>AIHQ (Ambiguous Intentions Hostility Questionnaire)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in social cognitive</measure>
    <time_frame>week 12</time_frame>
    <description>ACSO ( Self-Assessment Scale of Social Cognition Disorders)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in episodic verbal learning and memory</measure>
    <time_frame>week 12</time_frame>
    <description>CVLT( California Verbal Learning Test),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in visual attention and task switching</measure>
    <time_frame>week 12</time_frame>
    <description>TMT( Trial Making Test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in social functioning</measure>
    <time_frame>week 12</time_frame>
    <description>FEFSF (First Episode Social Functioning Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in symptoms at week 12</measure>
    <time_frame>week 12</time_frame>
    <description>PANSS (Positive And Negative Symptoms Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in visuospatial abilities at week 12</measure>
    <time_frame>week 12</time_frame>
    <description>TMT( Trial making Test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in executive functioning at week 12</measure>
    <time_frame>week 12</time_frame>
    <description>FNART(French National Adult reading Test)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>RC2S+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RC2S+&#xD;
Preparation sessions (sessions 1 &amp; 2):&#xD;
Functional Outcomes Scale - Social Cognition (ERF-CS)&#xD;
Psychoeducation about social cognitive impairments&#xD;
Concrete objectives&#xD;
Cognitive remediation (sessions 3 to 22):&#xD;
Paper-and-pencil session&#xD;
Simulation session&#xD;
Home-based task&#xD;
Transfer sessions (sessions 23 &amp; 24):&#xD;
Transfer of skills in dayly life - generalization&#xD;
Assessment of the achievement of objectives</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control therapy&#xD;
Preparation sessions (sessions 1 &amp; 2):&#xD;
Functional Outcomes Scale - Neurocognition&#xD;
Psychoeducation about cognitive impairments&#xD;
Concrete objectives&#xD;
Cognitive remediation (sessions 3 to 24):&#xD;
Paper-and-pencil session&#xD;
Simulation session&#xD;
Home-based task</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RC2S+</intervention_name>
    <description>new cognitive remediation program</description>
    <arm_group_label>RC2S+</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>active comparator</intervention_name>
    <description>cognitive remediation program</description>
    <arm_group_label>Control therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-45 years old&#xD;
&#xD;
          -  Diagnosis of schizophrenia assessed with DSM5 criteria (APA, 2013)&#xD;
&#xD;
          -  No modification of psychotropic treatment during the month before inclusion (variation&#xD;
             of 20% of the dose is tolerated&#xD;
&#xD;
          -  French native language or education in a French school since the first year of primary&#xD;
             school&#xD;
&#xD;
          -  Consent to participate to the study and agreement of the legal guardian&#xD;
&#xD;
          -  Patients who have not benefited from cognitive remediation during the three months&#xD;
             before inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substance use disorder (criteria of DSM-5), except for caffeine and tobacco&#xD;
&#xD;
          -  Neurologic disorders (vascular, infectious or neurodegenerative)&#xD;
&#xD;
          -  Uncorrected visual deficit&#xD;
&#xD;
          -  Medical drugs with cerebral or psychological effect (e.g, corticosteroids)&#xD;
&#xD;
          -  Patients resistant to antipsychotic medication&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>FRANCK NICOLAS, PUPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>LE VINATIER HOSPITAL BRON FRANCE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>centre de réhabilitation - Hôpital le Vinatier</name>
      <address>
        <city>Lyon</city>
        <state>Rhône</state>
        <zip>69006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>social cognition</keyword>
  <keyword>cognitive remediation</keyword>
  <keyword>emotions</keyword>
  <keyword>theory of mind</keyword>
  <keyword>attributions</keyword>
  <keyword>social perception</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</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/NCT02976077
org study id: 2016-A01271-50
nct id: NCT02976077
lead sponsor: 
Background:

      Difficulties in social interactions are a central characteristic of people with
      schizophrenia, and can be partly explained by impairments of social cognitive processes.
      According to renown researchers, three to five social cognitive processes are usually altered
      in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional
      style; and (4 and 5) social perception and knowledge. The components of social cognition
      appear to be related to both symptomatology and functioning in everyday life.

      New strategies of cognitive remediation have been recently developed to target these deficits
      and few meta analyses have assessed the extent to which social cognitive remediation programs
      have led to multiple improvements for schizophrenia patients. Overall, it seems that such
      therapies showed encouraging results in both patient interest and motivation, and social
      cognitive processes.

      The RC2S therapy is the first individualized and partly computerized program through which
      patients practice social interactions and develop social cognitive abilities with simulation
      techniques in a realistic environment.
Methods:

      This is a randomized controlled trial to establish the validity of the RC2S+ program in
      schizophrenia.

      The project's main objective is to assess the impact of RC2S+ on social cognitive impairments
      in schizophrenia compared with a cognitive remediation program (control therapy) focusing on
      neurocognition, equivalent in terms of number, duration and rhythm of sessions.

      The study has four other objectives:

        1. To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive
           processes

        2. To assess the impact of the RC2S+ therapy versus control therapy on social functioning

        3. To assess the impact of the RC2S+ therapy versus control therapy on both positive and
           negative symptoms

        4. To study the maintenance of benefits 3 months forward

      Outcomes:

      To treat social cognitive impairments in people with schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in the HB (Hostility Bias) score
time frame: week 12
description: AIHQ (Ambiguous Intentions Hostility Questionnaire)
measure: Change from baseline in social cognitive
time frame: week 12
description: ACSO ( Self-Assessment Scale of Social Cognition Disorders)
measure: Change from baseline in episodic verbal learning and memory
time frame: week 12
description: CVLT( California Verbal Learning Test),
measure: Change from baseline in visual attention and task switching
time frame: week 12
description: TMT( Trial Making Test)
measure: Change from baseline in social functioning
time frame: week 12
description: FEFSF (First Episode Social Functioning Scale)
measure: Change from baseline in symptoms at week 12
time frame: week 12
description: PANSS (Positive And Negative Symptoms Scale)
measure: Change from baseline in visuospatial abilities at week 12
time frame: week 12
description: TMT( Trial making Test)
measure: Change from baseline in executive functioning at week 12
time frame: week 12
description: FNART(French National Adult reading Test)
arm group label: RC2S+
arm group type: Experimental
description: RC2S+
Preparation sessions (sessions 1 & 2):
Functional Outcomes Scale - Social Cognition (ERF-CS)
Psychoeducation about social cognitive impairments
Concrete objectives
Cognitive remediation (sessions 3 to 22):
Paper-and-pencil session
Simulation session
Home-based task
Transfer sessions (sessions 23 & 24):
Transfer of skills in dayly life - generalization
Assessment of the achievement of objectives
arm group label: Control therapy
arm group type: Active Comparator
description: Control therapy
Preparation sessions (sessions 1 & 2):
Functional Outcomes Scale - Neurocognition
Psychoeducation about cognitive impairments
Concrete objectives
Cognitive remediation (sessions 3 to 24):
Paper-and-pencil session
Simulation session
Home-based task
intervention type: Behavioral
intervention name: RC2S+
description: new cognitive remediation program
arm group label: RC2S+
intervention type: Behavioral
intervention name: active comparator
description: cognitive remediation program
arm group label: Control therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: FRANCK NICOLAS, PUPH
role: Principal Investigator
affiliation: LE VINATIER HOSPITAL BRON FRANCE
facility: 
country: France
responsible party type: Sponsor
mesh term: Schizophrenia