<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/NCT04436757</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00777-32</org_study_id>
    <nct_id>NCT04436757</nct_id>
  </id_info>
  <brief_title>Self and Body-esteem in Socio-professional Rehabilitation</brief_title>
  <acronym>IPS_FIRAH</acronym>
  <official_title>Group Program IPS: Body-esteem and Self-esteem in a Psycho-social Rehabilitation Perspective</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>
      The body esteem influences the physical appearance, which can be a social brake. To enhance&#xD;
      the socio-professional insertion of persons with severe mental disorders, the investigators&#xD;
      developed a group program about self-presentation and body esteem. The study's objective is&#xD;
      to understand the body esteem impact on socio-professional insertion, and how to improve that&#xD;
      with a dedicated group program, for patients in a psychosocial rehabilitation center&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our hypothesis is that a group program centered on the image and the presentation of the&#xD;
      self, with the intervention of professionals of the image of the body, such as&#xD;
      socio-hairdresser, socio-beautician, allows a better socio-professional inclusion, through an&#xD;
      improvement in body self-esteem. Taking care of yourself will require different approaches&#xD;
      such as advice on hygiene, becoming aware of your body, experimenting with beauty treatments&#xD;
      and having the means to reproduce them at home. We will compare our IPS program (Image and&#xD;
      Presentation of Self), with the usual management in the care center (TAU = &quot;Treatment As&#xD;
      Usual&quot;)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>
    <intervention_model_description>Randomized, single-centre, comparative, interventional study, treated in open parallel groups, measuring the impact of &quot;professional&quot; body image intervention on improving body self-esteem in patients with severe mental health problems.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appreciation of one's own appearance</measure>
    <time_frame>baseline, one month, three months, nine months after the end of the treatment</time_frame>
    <description>The main judgement criterion is the difference before/after the program for each of the two groups (IPS and TAU) of the weighted average at the &quot;satisfaction with overall appearance&quot; and &quot;wish to change appearance&quot; dimensions of the BES (Body-Esteem Scale), common dimensions for men and women. This difference will be compared between the 2 groups by a Student test (or a Wilcoxon-Mann-Whitney test in case of non normality).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale</measure>
    <time_frame>baseline, one month, three months, nine months after the end of the treatment</time_frame>
    <description>As for the primary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appreciation of the well-being measured by the Warwick-Edinburgh Well-Being Mental Scale</measure>
    <time_frame>baseline, one month, three months, nine months after the end of the treatment</time_frame>
    <description>As for the primary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appreciation of the satisfaction level measured by the Client's Assessment of Strengths, Interests and Goals Scale (CASIG )</measure>
    <time_frame>baseline, one month, three months, nine months after the end of the treatment</time_frame>
    <description>As for the primary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appreciation of the satisfaction measured by the Satisfaction in the domains of life</measure>
    <time_frame>baseline, one month, three months, nine months after the end of the treatment</time_frame>
    <description>As for the primary outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Personality Disorders</condition>
  <condition>Anxiety Disorders</condition>
  <condition>Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>IPS (Self-image and body-representation program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IPS program (Self-image and body representation) was designed by Dr PLAZAT and coll. for specific use with patients with severe mental disorders suffering of low self- and body-esteem and aiming at &quot; reinsert themselves&quot; in the society.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment As Usual : the usual care proposed by the health service (SUR/CL3R).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IPS program : Self-image and body representation</intervention_name>
    <description>The IPS program consists in 13 sessions of 2 hours over a 13-weeks period.&#xD;
Sessions content is as follows :&#xD;
: Introduction&#xD;
: Sensory approach workshop&#xD;
: Self presentation and personal hygiene&#xD;
: Organisation of well-being, planning and pictograms&#xD;
: Becoming aware of my body, my envelope&#xD;
: Presentation and self-esteem (photolanguage)&#xD;
: Self-presentation in social interactions: Social codes&#xD;
: My ideas and desires for change&#xD;
: Places of well-being and clothing hygiene&#xD;
: Vocational insertion devices&#xD;
: Daring change : presence of a Socio-hairdresser&#xD;
: The awakening of color : presence of a Socio-aesthetician&#xD;
: Development of practice sheets and the network</description>
    <arm_group_label>IPS (Self-image and body-representation program)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by the health service. No additional session will be proposed.</description>
    <arm_group_label>TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 65.&#xD;
&#xD;
          -  Speaking French.&#xD;
&#xD;
          -  Diagnosis of severe mental disorders (MSD) established according to the criteria of&#xD;
             the DSM-V (Diagnostic and Statistical Manual of Mental Disorders) such as:&#xD;
             Schizophrenia, Bipolar Disorders, Serious Personality Disorders, Severe Anxiety&#xD;
             Disorders, Depressive Disorders; with a clinical stability of more than 3 months.&#xD;
&#xD;
          -  Supported at SUR/CL3R with an application for socio-professional reintegration.&#xD;
&#xD;
          -  Guardian agreement (for persons under guardianship);&#xD;
&#xD;
          -  Information given to the curator (for persons under curatorship);&#xD;
&#xD;
          -  Member of the social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Autism Spectrum Disorder (ASD) or Eating Behaviour Disorder.&#xD;
&#xD;
          -  Clinical status incompatible with group activity.&#xD;
&#xD;
          -  Acute episode in progress.&#xD;
&#xD;
          -  Refusal to participate.&#xD;
&#xD;
          -  Simultaneous participation in a psycho-social rehabilitation program targeting image&#xD;
             or self-esteem (general and/or body).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucie-Orianne PLAZAT, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier le Vinatier</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lucie-Orianne PLAZAT, M.D</last_name>
    <phone>0426738534</phone>
    <phone_ext>+33</phone_ext>
    <email>lucie-orianne.plazat@ch-le-vinatier.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emmanuel GAUTHIER, Ph.D.</last_name>
    <phone>0426738533</phone>
    <phone_ext>+33</phone_ext>
    <email>emmanuel.gauthier@ch-le-vinatier.fr</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck Nicolas, PUPH</last_name>
      <phone>+33 (0)4 26 23 76 11</phone>
      <email>nicolas.franck@ch-le-vinatier.fr</email>
    </contact>
    <contact_backup>
      <last_name>Gaudelus Baptiste</last_name>
      <phone>+33 (0)4 26 23 76 11</phone>
      <email>baptiste.gaudelus@ch-le-vinatier.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Franck Nicolas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</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>severe mental disorders</keyword>
  <keyword>body-esteem</keyword>
  <keyword>body-representation</keyword>
  <keyword>self-esteem</keyword>
  <keyword>socio-professional insertion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</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/NCT04436757
org study id: 2020-A00777-32
nct id: NCT04436757
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The body esteem influences the physical appearance, which can be a social brake. To enhance
      the socio-professional insertion of persons with severe mental disorders, the investigators
      developed a group program about self-presentation and body esteem. The study's objective is
      to understand the body esteem impact on socio-professional insertion, and how to improve that
      with a dedicated group program, for patients in a psychosocial rehabilitation center
Our hypothesis is that a group program centered on the image and the presentation of the
      self, with the intervention of professionals of the image of the body, such as
      socio-hairdresser, socio-beautician, allows a better socio-professional inclusion, through an
      improvement in body self-esteem. Taking care of yourself will require different approaches
      such as advice on hygiene, becoming aware of your body, experimenting with beauty treatments
      and having the means to reproduce them at home. We will compare our IPS program (Image and
      Presentation of Self), with the usual management in the care center (TAU = "Treatment As
      Usual")
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, single-centre, comparative, interventional study, treated in open parallel groups, measuring the impact of "professional" body image intervention on improving body self-esteem in patients with severe mental health problems.
primary purpose: Treatment
masking: None (Open Label)
measure: Appreciation of one's own appearance
time frame: baseline, one month, three months, nine months after the end of the treatment
description: The main judgement criterion is the difference before/after the program for each of the two groups (IPS and TAU) of the weighted average at the "satisfaction with overall appearance" and "wish to change appearance" dimensions of the BES (Body-Esteem Scale), common dimensions for men and women. This difference will be compared between the 2 groups by a Student test (or a Wilcoxon-Mann-Whitney test in case of non normality).
measure: Appreciation of the Self-esteem measured by the Self-Esteem Rating Scale
time frame: baseline, one month, three months, nine months after the end of the treatment
description: As for the primary outcome
measure: Appreciation of the well-being measured by the Warwick-Edinburgh Well-Being Mental Scale
time frame: baseline, one month, three months, nine months after the end of the treatment
description: As for the primary outcome
measure: Appreciation of the satisfaction level measured by the Client's Assessment of Strengths, Interests and Goals Scale (CASIG )
time frame: baseline, one month, three months, nine months after the end of the treatment
description: As for the primary outcome
measure: Appreciation of the satisfaction measured by the Satisfaction in the domains of life
time frame: baseline, one month, three months, nine months after the end of the treatment
description: As for the primary outcome
arm group label: IPS (Self-image and body-representation program)
arm group type: Experimental
description: The IPS program (Self-image and body representation) was designed by Dr PLAZAT and coll. for specific use with patients with severe mental disorders suffering of low self- and body-esteem and aiming at " reinsert themselves" in the society.
arm group label: TAU
arm group type: Active Comparator
description: Treatment As Usual : the usual care proposed by the health service (SUR/CL3R).
intervention type: Behavioral
intervention name: IPS program : Self-image and body representation
description: The IPS program consists in 13 sessions of 2 hours over a 13-weeks period.
Sessions content is as follows :
: Introduction
: Sensory approach workshop
: Self presentation and personal hygiene
: Organisation of well-being, planning and pictograms
: Becoming aware of my body, my envelope
: Presentation and self-esteem (photolanguage)
: Self-presentation in social interactions: Social codes
: My ideas and desires for change
: Places of well-being and clothing hygiene
: Vocational insertion devices
: Daring change : presence of a Socio-hairdresser
: The awakening of color : presence of a Socio-aesthetician
: Development of practice sheets and the network
arm group label: IPS (Self-image and body-representation program)
intervention type: Behavioral
intervention name: TAU
description: The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by the health service. No additional session will be proposed.
arm group label: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lucie-Orianne PLAZAT, M.D
role: Principal Investigator
affiliation: Centre Hospitalier le Vinatier
last name: Lucie-Orianne PLAZAT, M.D
phone: 0426738534
phone ext: +33
email: lucie-orianne.plazat@ch-le-vinatier.fr
last name: Emmanuel GAUTHIER, Ph.D.
phone: 0426738533
phone ext: +33
email: emmanuel.gauthier@ch-le-vinatier.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Depressive Disorder
mesh term: Bipolar Disorder
mesh term: Anxiety Disorders
mesh term: Personality Disorders
sharing ipd: No