<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/NCT03775564</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A01612-45</org_study_id>
    <nct_id>NCT03775564</nct_id>
  </id_info>
  <brief_title>Effectiveness of the RemedRugby Program</brief_title>
  <acronym>RemedRugby</acronym>
  <official_title>Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Center Alpes-Isère</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Le Valmont (Valence)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital le Vinatier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Spécialisé de la Savoie (Chambéry)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Annecy Genevois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Sainte Marie de Clermont Ferrand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Center Alpes-Isère</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>
      REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an&#xD;
      assertive way and to fight against stigma. It proposes to specifically target the processes&#xD;
      of &quot;social cognition&quot;.&#xD;
&#xD;
      &quot;Social cognition&quot; brings together the mental mechanisms that allow everyone to decipher the&#xD;
      social situations, emotions and intentions of others and interact with others in the&#xD;
      different contexts of everyday life.&#xD;
&#xD;
      People with a psychic handicap frequently have difficulties in this area, which has often&#xD;
      important consequences for their social and professional integration.&#xD;
&#xD;
      The REMEDRUGBY program proposes to work specifically on these processes in the context of&#xD;
      sport (+ role Play and blog) to strengthen the ability to interact with others and to deal&#xD;
      with the stigma that can be encountered on a daily basis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>RemedRugby program Vs TAU + TouchRugby</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Movie to Assess Social Cognition (MASC)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Symptoms Scale for Schizophrenia (PANSS)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Changes in the aggregates (average) of standardized performance levels : z-scores of positive and negative symptoms (minimum score 30- maximum score 210) of schizophrenia after social cognitive remediation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal and Social Performance scale (PSP)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after social cognitive remediation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Esteem Rating Scale (SERS)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Boston University Empowerment Scale (BUES)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1- maximum score 4) in self-assessment of empowerment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Internalized Stigma of Mental Illness (ISMI)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>self-assessment of internalized stigma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stages of Recovery Instrument (STORI)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Self-assessment of personal recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Perception and Knowledge (PerSo)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>cognitive task to assess competence in perception of social situations and social knowledge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambiguous Intentions and Hostility Questionnaire (AIHQ)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1, maximum score 6) at a cognitive task to measure hostile social cognitive bias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire of Cognitive and Affective Empathy</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 31, maximum score 124) in a self-assessment of empathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>French National Adult Reading Test (f-NART</measure>
    <time_frame>Baseline measure only</time_frame>
    <description>cognitive task to assess premorbid intellectual quotient (IQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test A (TMT A)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>cognitive task to assess speed of processing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test B (TMT B)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>cognitive task to assess reactive mental flexibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-assessment of Social Cognition (AcSo)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>self-assessment of patient' perception of social cognitive deficits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Commission Test (modified zoo test)</measure>
    <time_frame>Changes between baseline function, after intervention and at 6 months of follow-up</time_frame>
    <description>cognitive task to asess planification abilities</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Social Cognition</condition>
  <condition>Self Esteem</condition>
  <condition>Empowerment</condition>
  <condition>Recovery</condition>
  <arm_group>
    <arm_group_label>REMEDRUGBY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAU + RemedRugby Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU + TOUCH RUGBY</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAU + Touch Rugby Program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>REMEDRUGBY PROGRAM</intervention_name>
    <description>1st Session presentation of the programme, its objectives and a common reflection on the concepts of stigmatization/destigmatization.&#xD;
2nd to 4th session devoted to a group reflection on social conventions and their meaning followed by a practice by means of role-playing.&#xD;
5th to 7th session devoted to writing comments about tournaments on the blog by working on the intentions of others and the emotional impact of comments on their recipients.&#xD;
8th, 9th 11th sessions devoted to media relations with group reflection on the image of themselves and their pathology that participants wish to refer to the media, followed by a practice in role-playing games Interviewer-interviewed&#xD;
10th session devoted to planning and organizing the day of matches with writing a program of the day and spreading on the blog&#xD;
12th General Debriefing session Including : - 3 tournaments&#xD;
8 hours of Touch Rugby</description>
    <arm_group_label>REMEDRUGBY</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TOUCH RUGBY PROGRAM</intervention_name>
    <description>Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day</description>
    <arm_group_label>TAU + TOUCH RUGBY</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>Treatment as usual</description>
    <arm_group_label>REMEDRUGBY</arm_group_label>
    <arm_group_label>TAU + TOUCH RUGBY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of schizophrenia, schizo-affective disorder (DSM-V criteria; APA, 2013).&#xD;
&#xD;
          -  French mother tongue.&#xD;
&#xD;
          -  psychotropic treatment unchanged during the month prior to inclusion.&#xD;
&#xD;
          -  Patients who gave their informed consent to participate in the study.&#xD;
&#xD;
          -  affiliated with a social security scheme or beneficiary of such a scheme&#xD;
&#xD;
          -  Subject suitable for the practice of sport.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent dependence and abuse on cannabis or any other substance (DSM-V criteria),&#xD;
             except tobacco.&#xD;
&#xD;
          -  Neurological disorders of vascular, infectious or neurodegenerative origin.&#xD;
&#xD;
          -  taking of medicinal products with a cerebral or psychic impact (e.g.,&#xD;
             corticosteroids).&#xD;
&#xD;
          -  Inability to practice sport&#xD;
&#xD;
          -  Pregnancy planned or in progress&#xD;
&#xD;
          -  Simultaneous Participation in any other program of remediation of social cognition,&#xD;
             training in social skills, self-esteem.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien JD DUBREUCQ, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Center Alpes-Isère</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ch Annecy-Genevois</name>
      <address>
        <city>Annecy</city>
        <state>Aura</state>
        <zip>74000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Le Vinatier</name>
      <address>
        <city>Bron</city>
        <state>Aura</state>
        <zip>69678</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chs de La Savoie</name>
      <address>
        <city>Chambéry</city>
        <state>Aura</state>
        <zip>73000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Sainte-Marie</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Aura</state>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de CLERMONT-FERRAND</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Aura</state>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCAlpesIsere</name>
      <address>
        <city>Saint-Égrève</city>
        <state>Aura</state>
        <zip>38120</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <state>Aura</state>
        <zip>42000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chs Le Valmont</name>
      <address>
        <city>Valence</city>
        <state>Aura</state>
        <zip>26000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Center Alpes-Isère</investigator_affiliation>
    <investigator_full_name>Dr Julien Dubreucq</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <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/NCT03775564
org study id: 2014-A01612-45
nct id: NCT03775564
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an
      assertive way and to fight against stigma. It proposes to specifically target the processes
      of "social cognition".

      "Social cognition" brings together the mental mechanisms that allow everyone to decipher the
      social situations, emotions and intentions of others and interact with others in the
      different contexts of everyday life.

      People with a psychic handicap frequently have difficulties in this area, which has often
      important consequences for their social and professional integration.

      The REMEDRUGBY program proposes to work specifically on these processes in the context of
      sport (+ role Play and blog) to strengthen the ability to interact with others and to deal
      with the stigma that can be encountered on a daily basis.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: RemedRugby program Vs TAU + TouchRugby
primary purpose: Treatment
masking: None (Open Label)
measure: Movie to Assess Social Cognition (MASC)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation
measure: Positive and Negative Symptoms Scale for Schizophrenia (PANSS)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Changes in the aggregates (average) of standardized performance levels : z-scores of positive and negative symptoms (minimum score 30- maximum score 210) of schizophrenia after social cognitive remediation
measure: Personal and Social Performance scale (PSP)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Changes in the aggregates (average) of standardized performance levels : z-scores of social function (0 to 100) after social cognitive remediation
measure: Self Esteem Rating Scale (SERS)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 10-maximum score 70) in self-assessment of self-esteem
measure: Boston University Empowerment Scale (BUES)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1- maximum score 4) in self-assessment of empowerment
measure: Internalized Stigma of Mental Illness (ISMI)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: self-assessment of internalized stigma
measure: Stages of Recovery Instrument (STORI)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Self-assessment of personal recovery
measure: Social Perception and Knowledge (PerSo)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: cognitive task to assess competence in perception of social situations and social knowledge
measure: Ambiguous Intentions and Hostility Questionnaire (AIHQ)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 1, maximum score 6) at a cognitive task to measure hostile social cognitive bias
measure: Questionnaire of Cognitive and Affective Empathy
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: Changes in the aggregates (average) of standardized performance levels : z-scores (minimum score 31, maximum score 124) in a self-assessment of empathy
measure: French National Adult Reading Test (f-NART
time frame: Baseline measure only
description: cognitive task to assess premorbid intellectual quotient (IQ)
measure: Trail Making Test A (TMT A)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: cognitive task to assess speed of processing
measure: Trail Making Test B (TMT B)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: cognitive task to assess reactive mental flexibility
measure: Self-assessment of Social Cognition (AcSo)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: self-assessment of patient' perception of social cognitive deficits
measure: Commission Test (modified zoo test)
time frame: Changes between baseline function, after intervention and at 6 months of follow-up
description: cognitive task to asess planification abilities
arm group label: REMEDRUGBY
arm group type: Experimental
description: TAU + RemedRugby Program
arm group label: TAU + TOUCH RUGBY
arm group type: Active Comparator
description: TAU + Touch Rugby Program
intervention type: Other
intervention name: REMEDRUGBY PROGRAM
description: 1st Session presentation of the programme, its objectives and a common reflection on the concepts of stigmatization/destigmatization.
2nd to 4th session devoted to a group reflection on social conventions and their meaning followed by a practice by means of role-playing.
5th to 7th session devoted to writing comments about tournaments on the blog by working on the intentions of others and the emotional impact of comments on their recipients.
8th, 9th 11th sessions devoted to media relations with group reflection on the image of themselves and their pathology that participants wish to refer to the media, followed by a practice in role-playing games Interviewer-interviewed
10th session devoted to planning and organizing the day of matches with writing a program of the day and spreading on the blog
12th General Debriefing session Including : - 3 tournaments
8 hours of Touch Rugby
arm group label: REMEDRUGBY
intervention type: Other
intervention name: TOUCH RUGBY PROGRAM
description: Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day
arm group label: TAU + TOUCH RUGBY
intervention type: Other
intervention name: TAU
description: Treatment as usual
arm group label: REMEDRUGBY
arm group label: TAU + TOUCH RUGBY
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Julien JD DUBREUCQ, MD
role: Principal Investigator
affiliation: Hospital Center Alpes-Isère
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
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responsible party type: Principal Investigator
investigator affiliation: Hospital Center Alpes-Isère
investigator full name: Dr Julien Dubreucq
investigator title: Medical Doctor
mesh term: Schizophrenia