xml: <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/NCT06027658</url>
    </required_header>
    <id_info>
      <org_study_id>CERUBFC-2021-11-09-035</org_study_id>
      <nct_id>NCT06027658</nct_id>
    </id_info>
    <brief_title>Validation of a Dance as Therapy Program in Co-facilitation</brief_title>
    <acronym>VaDDanC</acronym>
    <official_title>Psychotherapeutic Care of Women Victims of Sexual Violence. Longitudinal Comparative Study and Therapeutic Evaluation of a Dance as Therapy Program.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Franche-Comté</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Lorraine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Roehampton</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>LOBA association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Franche-Comté</source>
    <oversight_info>
      <has_dmc>Yes</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 objective is to validate a psychotherapeutic group protocol of dance as therapy created&#xD;
        by LOBA association with a comparative non-randomized study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This present research is a prospective longitudinal monocentric comparative study of an&#xD;
        alternative, non-pharmacological therapy. It is a controlled, non-randomized, and&#xD;
        experimental study in which half of the participants benefit from an additional program with&#xD;
        speech and movement co-therapy via body activity, and the other half only benefit from&#xD;
        standard support (e.g. medical, social, and legal assistance, individual psychotherapy).&#xD;
  &#xD;
        The effect of this program will be examined across three dimensions:&#xD;
  &#xD;
          -  A clinical trial of N=80 participants to compare symptom improvement between individuals&#xD;
             receiving the standard support for victims of sexual violence (N=40) and those&#xD;
             receiving, in addition, the RECREATION program (N=40).&#xD;
  &#xD;
          -  A longitudinal evaluation of physiological conditions, psychological traits, and social&#xD;
             well-being of RECREATION workshop attendees (N=10) versus victims not participating in&#xD;
             said workshops (N=10).&#xD;
  &#xD;
          -  A qualitative analysis of interviews with program participants and their associated&#xD;
             professionals (data saturation sample size).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2021</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of participants presenting an improvement in PCLS scores at 6 months</measure>
      <time_frame>6 months period between January 2022 and April 2024</time_frame>
      <description>Posttraumatic stress disorder checklist (PCLS) scores range from 0 to 85; a higher score means a worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of participants presenting an improvement in DASS-21 scores at 6 months</measure>
      <time_frame>6 months period between January 2022 and April 2024</time_frame>
      <description>Depression, Anxiety, and Stress Scale in 21 (DASS-21) items scores range from 0 to 63; a higher score means a worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of participants presenting an improvement in QSCPGS scores at 6 months</measure>
      <time_frame>6 months period between January 2022 and April 2024</time_frame>
      <description>Body satisfaction and global self-perception questionnaire (QSCPGS) scores range from -100 to +100; a higher score means a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of participants presenting an improvement in SF-36 scores at 6 months</measure>
      <time_frame>6 months period between January 2022 and April 2024</time_frame>
      <description>Short Form Health Survey in 36 items (SF-36) scores range from 0 to 100; a higher score means a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of participants presenting an improvement in SSQ6 scores at 6 months</measure>
      <time_frame>6 months period between January 2022 and April 2024</time_frame>
      <description>Social Support Questionnaire in 6 items (SSQ6) scores range from 0 to 54 for the availability subscale and from 6 to 36 for the satisfaction subscale. For both subscales, a higher score means a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of participants presenting a change in RSQ score at 6 months</measure>
      <time_frame>6 months period between January 2022 and April 2024</time_frame>
      <description>Relationship Scales Questionnaire (RSQ) scores give an attachment profile, attachment strategies and a self and other model.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of participants presenting an improvement in RFQ8 score at 6 months</measure>
      <time_frame>6 months period between January 2022 and April 2024</time_frame>
      <description>Reflexive Functioning Questionnaire in 8 items (RFQ8) scores range from 0 to 18; a higher score means a worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants presenting an improvement in Rorschach protocol at 1 year</measure>
      <time_frame>A year between April 2022 and December 2023</time_frame>
      <description>Rorschach protocols are interpreted both qualitatively and quantitatively (psychogram). This outcome focuses on trauma symptomatology.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants presenting an improvement in AAI scores at 1 year</measure>
      <time_frame>A year between April 2022 and December 2023</time_frame>
      <description>Adult Attachment Interview (AAI) scores range from 0 to 90; a higher score means a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of identical themes in participants' and professionals' semi-structured interviews</measure>
      <time_frame>One interview per person between September 2022 and March 2023</time_frame>
      <description>Number of identical themes in participants' and professionals' semi-structured interviews</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Trauma, Psychological</condition>
    <condition>Depression, Anxiety</condition>
    <condition>Stress</condition>
    <condition>Body Image</condition>
    <condition>Quality of Life</condition>
    <condition>Social Relationship</condition>
    <condition>Attachment Disorder</condition>
    <arm_group>
      <arm_group_label>Non participants</arm_group_label>
      <description>Individuals receiving the standard support for victims of sexual violence (e.g. medical, social, and legal assistance, individual psychotherapy)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Participants</arm_group_label>
      <description>Individuals receiving the RECREATION program in addition to standard support for victims of sexual violence</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Long term participants</arm_group_label>
      <description>Individual receiving the RECREATION program for at least a month</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Professionals</arm_group_label>
      <description>Professionals associated with long term participants, working with them for standard support</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>RECREATION therapy</intervention_name>
      <description>Dance as therapy program with speech and movement co-therapy via body activity.</description>
      <arm_group_label>Long term participants</arm_group_label>
      <arm_group_label>Participants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Migration-affected adult women (over 18 years old) victims of sexual violence, mostly born&#xD;
          in Subsaharian African Countries.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  French-speaking women over 18 years old, victims of sexual violence&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-French-speaking person, under 18 years old, men, not victims of sexual violence&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rose-Angélique Belot</last_name>
      <role>Study Director</role>
      <affiliation>Université de Franche-Comté, Fr</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Crystal Tomaszewski</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université de Franche-Comté, Université de Lorraine, LOBA, Fr</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Aziz Essadek</last_name>
      <role>Study Director</role>
      <affiliation>Université de Lorraine, Fr</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Christophe Clesse</last_name>
      <role>Study Director</role>
      <affiliation>University of Roehampton, UK</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Crystal Tomaszewski</last_name>
      <phone>+33783012669</phone>
      <email>crystal.tomaszewski@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>LOBA</name>
        <address>
          <city>Paris</city>
          <zip>75006</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Crystal Tomaszewski</last_name>
        <email>crystal.tomaszewski@recreationbyloba.com</email>
      </contact>
      <contact_backup>
        <last_name>Héloïse Onumba-Bessonnet</last_name>
        <email>equipe@recreationbyloba.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Tomaszewski C, Belot RA, Essadek A, Onumba-Bessonnet H, Clesse C. Impact of dance therapy on adults with psychological trauma: a systematic review. Eur J Psychotraumatol. 2023;14(2):2225152. doi: 10.1080/20008066.2023.2225152.</citation>
      <PMID>37427835</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Franche-Comté</investigator_affiliation>
      <investigator_full_name>Crystal Tomaszewski</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Sexual violence</keyword>
    <keyword>Trauma</keyword>
    <keyword>Psychotherapy</keyword>
    <keyword>Dance as therapy</keyword>
    <keyword>Longitudinal study</keyword>
    <keyword>Attachment</keyword>
    <keyword>Mentalization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psychological Trauma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027658
  org study id: CERUBFC-2021-11-09-035
  nct id: NCT06027658
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective is to validate a psychotherapeutic group protocol of dance as therapy created
        by LOBA association with a comparative non-randomized study.
  This present research is a prospective longitudinal monocentric comparative study of an
        alternative, non-pharmacological therapy. It is a controlled, non-randomized, and
        experimental study in which half of the participants benefit from an additional program with
        speech and movement co-therapy via body activity, and the other half only benefit from
        standard support (e.g. medical, social, and legal assistance, individual psychotherapy).
  
        The effect of this program will be examined across three dimensions:
  
          -  A clinical trial of N=80 participants to compare symptom improvement between individuals
             receiving the standard support for victims of sexual violence (N=40) and those
             receiving, in addition, the RECREATION program (N=40).
  
          -  A longitudinal evaluation of physiological conditions, psychological traits, and social
             well-being of RECREATION workshop attendees (N=10) versus victims not participating in
             said workshops (N=10).
  
          -  A qualitative analysis of interviews with program participants and their associated
             professionals (data saturation sample size).
  observational model: Case-Control
  time perspective: Prospective
  measure: Rate of participants presenting an improvement in PCLS scores at 6 months
  time frame: 6 months period between January 2022 and April 2024
  description: Posttraumatic stress disorder checklist (PCLS) scores range from 0 to 85; a higher score means a worse outcome.
  measure: Rate of participants presenting an improvement in DASS-21 scores at 6 months
  time frame: 6 months period between January 2022 and April 2024
  description: Depression, Anxiety, and Stress Scale in 21 (DASS-21) items scores range from 0 to 63; a higher score means a worse outcome.
  measure: Rate of participants presenting an improvement in QSCPGS scores at 6 months
  time frame: 6 months period between January 2022 and April 2024
  description: Body satisfaction and global self-perception questionnaire (QSCPGS) scores range from -100 to +100; a higher score means a better outcome
  measure: Rate of participants presenting an improvement in SF-36 scores at 6 months
  time frame: 6 months period between January 2022 and April 2024
  description: Short Form Health Survey in 36 items (SF-36) scores range from 0 to 100; a higher score means a better outcome
  measure: Rate of participants presenting an improvement in SSQ6 scores at 6 months
  time frame: 6 months period between January 2022 and April 2024
  description: Social Support Questionnaire in 6 items (SSQ6) scores range from 0 to 54 for the availability subscale and from 6 to 36 for the satisfaction subscale. For both subscales, a higher score means a better outcome
  measure: Rate of participants presenting a change in RSQ score at 6 months
  time frame: 6 months period between January 2022 and April 2024
  description: Relationship Scales Questionnaire (RSQ) scores give an attachment profile, attachment strategies and a self and other model.
  measure: Rate of participants presenting an improvement in RFQ8 score at 6 months
  time frame: 6 months period between January 2022 and April 2024
  description: Reflexive Functioning Questionnaire in 8 items (RFQ8) scores range from 0 to 18; a higher score means a worse outcome.
  measure: Number of participants presenting an improvement in Rorschach protocol at 1 year
  time frame: A year between April 2022 and December 2023
  description: Rorschach protocols are interpreted both qualitatively and quantitatively (psychogram). This outcome focuses on trauma symptomatology.
  measure: Number of participants presenting an improvement in AAI scores at 1 year
  time frame: A year between April 2022 and December 2023
  description: Adult Attachment Interview (AAI) scores range from 0 to 90; a higher score means a better outcome.
  measure: Number of identical themes in participants' and professionals' semi-structured interviews
  time frame: One interview per person between September 2022 and March 2023
  description: Number of identical themes in participants' and professionals' semi-structured interviews
  arm group label: Non participants
  description: Individuals receiving the standard support for victims of sexual violence (e.g. medical, social, and legal assistance, individual psychotherapy)
  arm group label: Participants
  description: Individuals receiving the RECREATION program in addition to standard support for victims of sexual violence
  arm group label: Long term participants
  description: Individual receiving the RECREATION program for at least a month
  arm group label: Professionals
  description: Professionals associated with long term participants, working with them for standard support
  intervention type: Behavioral
  intervention name: RECREATION therapy
  description: Dance as therapy program with speech and movement co-therapy via body activity.
  arm group label: Long term participants
  arm group label: Participants
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rose-Angélique Belot
  role: Study Director
  affiliation: Université de Franche-Comté, Fr
  last name: Crystal Tomaszewski
  role: Principal Investigator
  affiliation: Université de Franche-Comté, Université de Lorraine, LOBA, Fr
  last name: Aziz Essadek
  role: Study Director
  affiliation: Université de Lorraine, Fr
  last name: Christophe Clesse
  role: Study Director
  affiliation: University of Roehampton, UK
  last name: Crystal Tomaszewski
  phone: +33783012669
  email: crystal.tomaszewski@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  citation: Tomaszewski C, Belot RA, Essadek A, Onumba-Bessonnet H, Clesse C. Impact of dance therapy on adults with psychological trauma: a systematic review. Eur J Psychotraumatol. 2023;14(2):2225152. doi: 10.1080/20008066.2023.2225152.
  PMID: 37427835
  responsible party type: Principal Investigator
  investigator affiliation: University of Franche-Comté
  investigator full name: Crystal Tomaszewski
  investigator title: Principal Investigator
  mesh term: Psychological Trauma
  sharing ipd: Undecided