<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/NCT04431531</url>
  </required_header>
  <id_info>
    <org_study_id>10477M-YOGA-EMDR</org_study_id>
    <nct_id>NCT04431531</nct_id>
  </id_info>
  <brief_title>EMDR Pre-treatment Yoga for Complex Trauma</brief_title>
  <acronym>YOGA-EMDR</acronym>
  <official_title>EMDR Pre-treatment Yoga for Complex Trauma Randomized Controlled Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Januel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de Ville-Evrard, France</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>
      Yoga practice has shown benefits in treating multiple physical or mental disorders (Barnes,&#xD;
      Bloom, &amp; Nahin, 2008; Khalsa, 2004; Ross, Friedmann, Bevans, &amp; Thomas, 2013) and has recently&#xD;
      been evaluated for PTSD. We identified six randomized controlled studies measuring the effect&#xD;
      of yoga in women (mostly) who experienced childhood violence (see table). With the exception&#xD;
      of one pilot study (Dick, Niles, Street, Dimartino, &amp; Mitchell, 2014; Mitchell et al., 2014),&#xD;
      all studies show a significant reduction in PTSD symptoms compared to the pre-treatment&#xD;
      period and compared to the control group (waiting list group). In particular, it was shown&#xD;
      that this reduction in symptomatology was comparable to that of other commonly practiced&#xD;
      psychotherapies, such as the exposure techniques of Behavioural and Cognitive Therapies or&#xD;
      EMDR, and comparable to pharmacological treatments (Van Der Kolk et al., 2014). Prolonged&#xD;
      yoga therapy would also significantly improve dissociative symptoms (Price et al., 2017).&#xD;
      However, all these studies tested the effect of yoga therapy in isolation, without&#xD;
      associating it with conventional and recommended treatments for trauma. However, given the&#xD;
      fields of action of the yoga listed above, we think that it could be the ideal tool to&#xD;
      prepare (in the pre-treatment phase) the work on traumatic memory. We believe that the&#xD;
      combination of yoga therapy and EMDR would work in synergy to reduce complex PTSD and achieve&#xD;
      a higher success rate than these individual approaches. In this work, we will use a yoga&#xD;
      technique adapted to the treatment of psycho-trauma called &quot;trauma sensitive yoga&quot; (Emerson,&#xD;
      2015).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">May 29, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 29, 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>the first group is about EMDR treatment. The second group is about YOGATHERAPY</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PCL-5</measure>
    <time_frame>FIRST WEEK</time_frame>
    <description>Scale of post-traumatic stress disorder</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCL-5</measure>
    <time_frame>AT TWENTY WEEK</time_frame>
    <description>Scale of post-traumatic stress disorder</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CAPS-5</measure>
    <time_frame>FIRST WEEK</time_frame>
    <description>PTSD Scale Administered by Clinician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CAPS-5</measure>
    <time_frame>AT TEN WEEK</time_frame>
    <description>PTSD Scale Administered by Clinician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CAPS-5</measure>
    <time_frame>AT TWENTY WEEK</time_frame>
    <description>PTSD Scale Administered by Clinician</description>
  </secondary_outcome>
  <other_outcome>
    <measure>CGI</measure>
    <time_frame>AT FIRST WEEK</time_frame>
    <description>Overall Clinical Print Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>CGI</measure>
    <time_frame>AT TEN WEEK</time_frame>
    <description>Overall Clinical Print Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>CGI</measure>
    <time_frame>AT TWENTY WEEK</time_frame>
    <description>Overall Clinical Print Scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Trauma, Psychological</condition>
  <arm_group>
    <arm_group_label>yogatherapy-EMDR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>waiting list and EMDR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The other group will have Eye movement desensibilization reprocessing</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>10 Sessions of yogatherapy associate with EMDR</intervention_name>
    <description>The first group will have Yogatherapy plus EMDR treatment</description>
    <arm_group_label>yogatherapy-EMDR</arm_group_label>
    <other_name>The second group will have EMDR without yogatherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The second group will have EMDR without yogatherapy</intervention_name>
    <description>the second one will have EMDR treatment</description>
    <arm_group_label>waiting list and EMDR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        . Women&#xD;
&#xD;
          -  Meets diagnostic criteria for Complex Post-traumatic Stress Disorder according to&#xD;
             ICD-11 criteria, related to childhood sexual abuse&#xD;
&#xD;
          -  PCL-5 must be at least 45&#xD;
&#xD;
          -  Age between 18 and 70.&#xD;
&#xD;
          -  Free, informed and signed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Neurological disorders&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Severe and/or unstable somatic diseases&#xD;
&#xD;
          -  Diseases resulting in serious motor disorders (e.g. people paralyzed)&#xD;
&#xD;
          -  Patient not affiliated with social security, State Medical Aid (AME)&#xD;
&#xD;
          -  Patient hospitalized under stress in psychiatric care at the decision of the state&#xD;
             representative or in psychiatric care at the request of a third party,&#xD;
&#xD;
          -  Patient under guardianship, curatorship and protection of justice&#xD;
&#xD;
          -  Patient participating in parallel biomedical research&#xD;
&#xD;
          -  French language not mastered&#xD;
&#xD;
          -  Persons unable to give consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only female can participate to this study</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ch Ville Evrard</name>
      <address>
        <city>Neuilly-sur-Marne</city>
        <zip>93330</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Psychotherapy and Psychotraumatology</name>
      <address>
        <city>Saint-Denis</city>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre hospitalier de Ville-Evrard, France</investigator_affiliation>
    <investigator_full_name>Januel</investigator_full_name>
    <investigator_title>HEAD OF THE UNIT OF CLINICAL RESEARCH</investigator_title>
  </responsible_party>
  <keyword>Yogatherapy-EMDR-psychiatry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <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>


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/NCT04431531
org study id: 10477M-YOGA-EMDR
nct id: NCT04431531
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Yoga practice has shown benefits in treating multiple physical or mental disorders (Barnes,
      Bloom, & Nahin, 2008; Khalsa, 2004; Ross, Friedmann, Bevans, & Thomas, 2013) and has recently
      been evaluated for PTSD. We identified six randomized controlled studies measuring the effect
      of yoga in women (mostly) who experienced childhood violence (see table). With the exception
      of one pilot study (Dick, Niles, Street, Dimartino, & Mitchell, 2014; Mitchell et al., 2014),
      all studies show a significant reduction in PTSD symptoms compared to the pre-treatment
      period and compared to the control group (waiting list group). In particular, it was shown
      that this reduction in symptomatology was comparable to that of other commonly practiced
      psychotherapies, such as the exposure techniques of Behavioural and Cognitive Therapies or
      EMDR, and comparable to pharmacological treatments (Van Der Kolk et al., 2014). Prolonged
      yoga therapy would also significantly improve dissociative symptoms (Price et al., 2017).
      However, all these studies tested the effect of yoga therapy in isolation, without
      associating it with conventional and recommended treatments for trauma. However, given the
      fields of action of the yoga listed above, we think that it could be the ideal tool to
      prepare (in the pre-treatment phase) the work on traumatic memory. We believe that the
      combination of yoga therapy and EMDR would work in synergy to reduce complex PTSD and achieve
      a higher success rate than these individual approaches. In this work, we will use a yoga
      technique adapted to the treatment of psycho-trauma called "trauma sensitive yoga" (Emerson,
      2015).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: the first group is about EMDR treatment. The second group is about YOGATHERAPY
primary purpose: Other
masking: None (Open Label)
measure: PCL-5
time frame: FIRST WEEK
description: Scale of post-traumatic stress disorder
measure: PCL-5
time frame: AT TWENTY WEEK
description: Scale of post-traumatic stress disorder
measure: CAPS-5
time frame: FIRST WEEK
description: PTSD Scale Administered by Clinician
measure: CAPS-5
time frame: AT TEN WEEK
description: PTSD Scale Administered by Clinician
measure: CAPS-5
time frame: AT TWENTY WEEK
description: PTSD Scale Administered by Clinician
measure: CGI
time frame: AT FIRST WEEK
description: Overall Clinical Print Scale
measure: CGI
time frame: AT TEN WEEK
description: Overall Clinical Print Scale
measure: CGI
time frame: AT TWENTY WEEK
description: Overall Clinical Print Scale
arm group label: yogatherapy-EMDR
arm group type: Active Comparator
description: one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR)
arm group label: waiting list and EMDR
arm group type: Active Comparator
description: The other group will have Eye movement desensibilization reprocessing
intervention type: Other
intervention name: 10 Sessions of yogatherapy associate with EMDR
description: The first group will have Yogatherapy plus EMDR treatment
arm group label: yogatherapy-EMDR
other name: The second group will have EMDR without yogatherapy
intervention type: Other
intervention name: The second group will have EMDR without yogatherapy
description: the second one will have EMDR treatment
arm group label: waiting list and EMDR
criteria: 
gender: Female
gender based: Yes
gender description: Only female can participate to this study
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Centre hospitalier de Ville-Evrard, France
investigator full name: Januel
investigator title: HEAD OF THE UNIT OF CLINICAL RESEARCH
mesh term: Wounds and Injuries
mesh term: Psychological Trauma
sharing ipd: Undecided