<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/NCT03028545</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01049-42</org_study_id>
    <nct_id>NCT03028545</nct_id>
  </id_info>
  <brief_title>Representations and Strategies for Recovery</brief_title>
  <acronym>EPR</acronym>
  <official_title>Representations, Strategies and Identity Redefinition in the Recovery Process: Exploratory Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital le Vinatier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital le Vinatier</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>
      In the recent context of deinstitutionalization and longitudinal studies pointing to a large&#xD;
      number of positive long-term outcommes for people affected by a psychiatric disorder&#xD;
      (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the&#xD;
      possibility of overcoming the consequences of a psychiatric pathology emerges as a solid&#xD;
      fact. Therefore, the existence of this possibility calls for the identification of the&#xD;
      determinants underlying of the various outcomes over time of those affected by a severe&#xD;
      psychiatric disorder, in particular those likely to underpin the most positive developments.&#xD;
&#xD;
      While it is well known from a medical point of view that certain dimensions affect the&#xD;
      prognosis of persons affected by a severe psychiatric disorder (such as the persistence of&#xD;
      negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely&#xD;
      medical perspective (and putting aside the role of the person and his environment) seems to&#xD;
      be able to account only for a modest proportion of the prognosis of people affected by a&#xD;
      serious psychiatric disorder.&#xD;
&#xD;
      It is this fact that has gradually led to the emergence of complementary models capable of&#xD;
      enriching the understanding of the determinants of the future of people affected by a severe&#xD;
      psychiatric disorder, in particular models inviting to separate &quot;becoming of the person&quot; from&#xD;
      the &quot; psychiatric disorder &quot;to take into account the&quot; personal role of the person &quot;in his or&#xD;
      her own healing. This perspective is the &quot;recovery&quot; perspective.&#xD;
&#xD;
      Recovery process is defined as a personal trajectory which includes the person's experiences&#xD;
      and the reactions of his / her environment following the installation of a psychiatric&#xD;
      disorder, which can support a mode of release of the status of &quot;psychiatric patient&quot;.&#xD;
      Recovery thus implies an &quot;approach underpinned by the understanding of the human response to&#xD;
      pathology&quot; (Noiseux) and, one might add, of its environment.&#xD;
&#xD;
      However, while these studies point to a number of crucial dimensions involved in the recovery&#xD;
      of a severe psychiatric disorder, one of the important limitations of these studies is the&#xD;
      distance from any psychopathological consideration, thus setting aside the possibility of&#xD;
      specific processes of recovery depending of the pathology. The identification of recurrent&#xD;
      experiential logics specific to the various psychiatric disorders therefore appears to be an&#xD;
      important field of investigation. It would potentially be able to guide the development of&#xD;
      new therapeutic devices based on the recovery model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Elaboration of a semi directed grid (exploratory phase)&#xD;
&#xD;
        2. Collection of individual narratives&#xD;
&#xD;
        3. Data analysis, according to IPA method (interpretative phenomenological analysis)&#xD;
&#xD;
             -  On the basis of individual narratives&#xD;
&#xD;
             -  On the basis of a focus group&#xD;
&#xD;
        4. Publication of results&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Collection of individual narratives to understand the recovery process</measure>
    <time_frame>one year</time_frame>
    <description>Semi-directed maintenance grid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Quality of Well-Being at one year</measure>
    <time_frame>one year</time_frame>
    <description>Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measures of psychological recovery at one year</measure>
    <time_frame>one year</time_frame>
    <description>Stages of recovery instrument (STORI ANDREASEN)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Schizophrenia, Undifferentiated</condition>
  <condition>Anorexia</condition>
  <condition>Bipolar Disorders</condition>
  <condition>Personality Disorders</condition>
  <arm_group>
    <arm_group_label>schizophrenia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in schizophrenia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bipolar disorders</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in bipolar disorders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eating disorders</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in eating disorders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>personality disorders</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in personality disorders</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Collection of the individual narrative, semi-directed interviews</intervention_name>
    <description>Visit one : individual interview Individual narrative Passing Psychometric Measurement Scales of Recovery: Score at Warwick and Wellness Scale Andreasen scale score Visit two Focus group</description>
    <arm_group_label>bipolar disorders</arm_group_label>
    <arm_group_label>eating disorders</arm_group_label>
    <arm_group_label>personality disorders</arm_group_label>
    <arm_group_label>schizophrenia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 80 years&#xD;
&#xD;
          -  Psychiatric diagnosis according to DSM V critera of schizophrenia, eating disorder,&#xD;
             bipolar disorder, personality disorder&#xD;
&#xD;
          -  In recovery scale&#xD;
&#xD;
          -  Informed of their diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute psychiatric state&#xD;
&#xD;
          -  Poor understanding of french language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARTIN BRICE, MD/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH LE VINATIER</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vial Veronique</name>
      <address>
        <city>Bron</city>
        <state>Rhone Alpes</state>
        <zip>69678</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>anorexia</keyword>
  <keyword>bipolar disorders</keyword>
  <keyword>personality disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Personality Disorders</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/NCT03028545
org study id: 2016-A01049-42
nct id: NCT03028545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the recent context of deinstitutionalization and longitudinal studies pointing to a large
      number of positive long-term outcommes for people affected by a psychiatric disorder
      (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the
      possibility of overcoming the consequences of a psychiatric pathology emerges as a solid
      fact. Therefore, the existence of this possibility calls for the identification of the
      determinants underlying of the various outcomes over time of those affected by a severe
      psychiatric disorder, in particular those likely to underpin the most positive developments.

      While it is well known from a medical point of view that certain dimensions affect the
      prognosis of persons affected by a severe psychiatric disorder (such as the persistence of
      negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely
      medical perspective (and putting aside the role of the person and his environment) seems to
      be able to account only for a modest proportion of the prognosis of people affected by a
      serious psychiatric disorder.

      It is this fact that has gradually led to the emergence of complementary models capable of
      enriching the understanding of the determinants of the future of people affected by a severe
      psychiatric disorder, in particular models inviting to separate "becoming of the person" from
      the " psychiatric disorder "to take into account the" personal role of the person "in his or
      her own healing. This perspective is the "recovery" perspective.

      Recovery process is defined as a personal trajectory which includes the person's experiences
      and the reactions of his / her environment following the installation of a psychiatric
      disorder, which can support a mode of release of the status of "psychiatric patient".
      Recovery thus implies an "approach underpinned by the understanding of the human response to
      pathology" (Noiseux) and, one might add, of its environment.

      However, while these studies point to a number of crucial dimensions involved in the recovery
      of a severe psychiatric disorder, one of the important limitations of these studies is the
      distance from any psychopathological consideration, thus setting aside the possibility of
      specific processes of recovery depending of the pathology. The identification of recurrent
      experiential logics specific to the various psychiatric disorders therefore appears to be an
      important field of investigation. It would potentially be able to guide the development of
      new therapeutic devices based on the recovery model.
1. Elaboration of a semi directed grid (exploratory phase)

        2. Collection of individual narratives

        3. Data analysis, according to IPA method (interpretative phenomenological analysis)

             -  On the basis of individual narratives

             -  On the basis of a focus group

        4. Publication of results
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Collection of individual narratives to understand the recovery process
time frame: one year
description: Semi-directed maintenance grid
measure: Change from baseline in the Quality of Well-Being at one year
time frame: one year
description: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
measure: Change from baseline in measures of psychological recovery at one year
time frame: one year
description: Stages of recovery instrument (STORI ANDREASEN)
arm group label: schizophrenia
arm group type: Other
description: Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in schizophrenia
arm group label: bipolar disorders
arm group type: Other
description: Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in bipolar disorders
arm group label: eating disorders
arm group type: Other
description: Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in eating disorders
arm group label: personality disorders
arm group type: Other
description: Exploring and understanding, through a multidisciplinary exploration (medical, anthropological and sociological) representations and recovery strategies in personality disorders
intervention type: Behavioral
intervention name: Collection of the individual narrative, semi-directed interviews
description: Visit one : individual interview Individual narrative Passing Psychometric Measurement Scales of Recovery: Score at Warwick and Wellness Scale Andreasen scale score Visit two Focus group
arm group label: bipolar disorders
arm group label: eating disorders
arm group label: personality disorders
arm group label: schizophrenia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: MARTIN BRICE, MD/PhD
role: Principal Investigator
affiliation: CH LE VINATIER
facility: 
country: France
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Personality Disorders
sharing ipd: No