<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/NCT04431765</url>
  </required_header>
  <id_info>
    <org_study_id>10477M-ICE-EMDR</org_study_id>
    <nct_id>NCT04431765</nct_id>
  </id_info>
  <brief_title>Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]</brief_title>
  <acronym>ICE-EMDR</acronym>
  <official_title>Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]: Neuronal Correlates and Cognitive Impact on the Attention and Memory of Emotional Stimuli.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de Ville-Evrard, France</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>
      This research aims to confirm that the therapeutic effect of EMDR is associated with changes&#xD;
      in the interaction between cognitive function and emotional stimuli in PTSD patients compared&#xD;
      to a controlled therapy in a randomized, single-blind study.On the other hand, this study&#xD;
      aims to observe neuronal and cognitive correlates related to EMDR therapy compared to a&#xD;
      control therapy.&#xD;
&#xD;
      This investigation would improve the understanding of the mechanisms of action of the EMDR,&#xD;
      still unknown to date.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2, 2018</start_date>
  <completion_date type="Anticipated">February 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2026</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>In one hand, Patients with Post-traumatic Stress Disorder who will receive Eye Movement desensitization reprocessing therapy and in other hand patient with post-traumatic Stress Disorder who will receive Trauma-Centred Cognitive and Behavioural Therapy</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post Traumatic Stress Scale-5 (PCL-5)</measure>
    <time_frame>Before the therapy begins, at day 0</time_frame>
    <description>The PCL-5 is a self-assessment consisting of 20 items that measures the 20 PTSD symptoms of the DSM-5. The wording of the PCL-5 items reflects both changes in existing symptoms and the addition of new symptoms in the DSM-5.&#xD;
The objectives of PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with PTSD, making an interim diagnosis of PTSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post Traumatic Stress Scale-5</measure>
    <time_frame>Within 3 weeks before the end of the therapy</time_frame>
    <description>The PCL-5 is a self-assessment consisting of 20 items that measures the 20 PTSD symptoms of the DSM-5. The wording of the PCL-5 items reflects both changes in existing symptoms and the addition of new symptoms in the DSM-5.&#xD;
The objectives of PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with PTSD, making an interim diagnosis of PTSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State Trait Anxiety Inventory (STAI)</measure>
    <time_frame>Before the therapy begins, at day 0</time_frame>
    <description>The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State Trait Anxiety Inventory (STAI)</measure>
    <time_frame>Within 3 weeks before the end of the therapy</time_frame>
    <description>The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Short Form (36) Health Survey (SF36)</measure>
    <time_frame>Before the therapy begins, at day 0</time_frame>
    <description>TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Short Form (36) Health Survey (SF36)</measure>
    <time_frame>Within 3 weeks before the end of the therapy</time_frame>
    <description>TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Childhood Trauma Questionnaire (CTQ)</measure>
    <time_frame>Before the therapy begins, at day 0</time_frame>
    <description>The Childhood Trauma Questionnaire (CTQ) is a questionnaire developed by Bernstein et al. (1994) that includes 70 items with a Likert scale in five response choices (from 1 = &quot;never true&quot; to 5 = &quot;very often true&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Childhood Trauma Questionnaire (CTQ)</measure>
    <time_frame>Within 3 weeks before the end of the therapy</time_frame>
    <description>The Childhood Trauma Questionnaire (CTQ) is a questionnaire developed by Bernstein et al. (1994) that includes 70 items with a Likert scale in five response choices (from 1 = &quot;never true&quot; to 5 = &quot;very often true&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinician Administered PTSD Scale for DSM-5[CAPS-5])</measure>
    <time_frame>Before the therapy begins, at day 0</time_frame>
    <description>he CAPS-5 is a 30-item structured interview that can be used to:&#xD;
Make current (past month) diagnosis of PTSD,Make lifetime diagnosis of PTSD, Assess PTSD symptoms over the past week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinician Administered PTSD Scale for DSM-5[CAPS-5])</measure>
    <time_frame>Within 3 weeks before the end of the therapy</time_frame>
    <description>he CAPS-5 is a 30-item structured interview that can be used to:&#xD;
Make current (past month) diagnosis of PTSD,Make lifetime diagnosis of PTSD, Assess PTSD symptoms over the past week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression (CGI)</measure>
    <time_frame>Before the therapy begins, at day 0</time_frame>
    <description>The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression (CGI)</measure>
    <time_frame>Within 3 weeks before the end of the therapy</time_frame>
    <description>The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Post-traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Patient for Eye Movement desensitization Reprocessing therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients for Trauma-Centred Cognitive and Behavioural Therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eye Movement Desensitization Reprocessing therapy</intervention_name>
    <description>The Eye Movement Desensitization Reprocessing therapy uses bi-alternating (right-left) sensory stimulation through eye movements. The patient follows the therapist's fingers from right to left in front of his eyes and also by auditory stimuli. The patient wears a helmet that alternately makes him hear a sound to the right, then to the left or touch the patient holds in his hands buzzers that alternately vibrate from right to left, or alternatively the therapist taps the patient's knees or the back of his hands.</description>
    <arm_group_label>Patient for Eye Movement desensitization Reprocessing therapy</arm_group_label>
    <other_name>EMDR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trauma-Centred Cognitive and Behavioural Therapy</intervention_name>
    <description>A CBT is a short, scientifically validated therapy that focuses on the interactions between thoughts, emotions and behaviours. These therapies focus on the current problems of the person, while taking into account their historical causes. They help gradually overcome disabling symptoms and aim to strengthen adaptive behaviours. A CBT relies on different techniques that help the patient to identify the mechanisms at the origin of his difficulties, to experiment with new behaviors and thus to gradually come out of vicious circles that perpetuate and aggravate the psychic suffering.</description>
    <arm_group_label>patients for Trauma-Centred Cognitive and Behavioural Therapy</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient diagnosed with PTSD according to DSM 5 criteria (APA 2013) related to a single&#xD;
             traumatic event,&#xD;
&#xD;
          -  Aged 18 to 65 years,&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Patient with social security affiliation or State Medical Aid (AME)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological disorders&#xD;
&#xD;
          -  No other major psychiatric disorders than PTSD (DSM 5)&#xD;
&#xD;
          -  Severe and/or unstable somatic pathologies,&#xD;
&#xD;
          -  Patient not affiliated with social security,&#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,&#xD;
&#xD;
          -  Patient participating in parallel with other biomedical research,&#xD;
&#xD;
          -  Change of antidepressant during the last three months,&#xD;
&#xD;
          -  Patient not fluent in French&#xD;
&#xD;
          -  MR-specific criteria for not inclusion:&#xD;
&#xD;
          -  women of childbearing age without effective contraception or a positive pregnancy&#xD;
             test,&#xD;
&#xD;
          -  patients carrying pacemakers or electrical or electronic devices, clips or metal&#xD;
             prostheses,&#xD;
&#xD;
          -  subjects with neurological disorders, cerebral abnormalities or suffering from&#xD;
             claustrophobia.&#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>Dominique Januel, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHVille Evrard</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rusheenthira THAVASEELAN, Msc</last_name>
    <phone>0143093232</phone>
    <email>r.thavaseelan@epsve.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Youcef BENCHERIF, MSC</last_name>
    <phone>0143093232</phone>
    <email>y.bencherif@epsve.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ch Ville Evrard</name>
      <address>
        <city>Neuilly-sur-Marne</city>
        <zip>93330</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Florence Durand, MSC</last_name>
      <email>f.durand@epsve.fr</email>
    </contact>
    <investigator>
      <last_name>Dominique Januel, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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 clinical research department (psychiatrist)</investigator_title>
  </responsible_party>
  <keyword>Eye Movement Information- Post-traumatic Stress Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT04431765
org study id: 10477M-ICE-EMDR
nct id: NCT04431765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research aims to confirm that the therapeutic effect of EMDR is associated with changes
      in the interaction between cognitive function and emotional stimuli in PTSD patients compared
      to a controlled therapy in a randomized, single-blind study.On the other hand, this study
      aims to observe neuronal and cognitive correlates related to EMDR therapy compared to a
      control therapy.

      This investigation would improve the understanding of the mechanisms of action of the EMDR,
      still unknown to date.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In one hand, Patients with Post-traumatic Stress Disorder who will receive Eye Movement desensitization reprocessing therapy and in other hand patient with post-traumatic Stress Disorder who will receive Trauma-Centred Cognitive and Behavioural Therapy
primary purpose: Other
masking: None (Open Label)
measure: Post Traumatic Stress Scale-5 (PCL-5)
time frame: Before the therapy begins, at day 0
description: The PCL-5 is a self-assessment consisting of 20 items that measures the 20 PTSD symptoms of the DSM-5. The wording of the PCL-5 items reflects both changes in existing symptoms and the addition of new symptoms in the DSM-5.
The objectives of PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with PTSD, making an interim diagnosis of PTSD.
measure: Post Traumatic Stress Scale-5
time frame: Within 3 weeks before the end of the therapy
description: The PCL-5 is a self-assessment consisting of 20 items that measures the 20 PTSD symptoms of the DSM-5. The wording of the PCL-5 items reflects both changes in existing symptoms and the addition of new symptoms in the DSM-5.
The objectives of PCL-5 are numerous, such as monitoring changes in symptoms during and after treatment, screening individuals with PTSD, making an interim diagnosis of PTSD.
measure: State Trait Anxiety Inventory (STAI)
time frame: Before the therapy begins, at day 0
description: The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
measure: State Trait Anxiety Inventory (STAI)
time frame: Within 3 weeks before the end of the therapy
description: The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
measure: The Short Form (36) Health Survey (SF36)
time frame: Before the therapy begins, at day 0
description: TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).
measure: The Short Form (36) Health Survey (SF36)
time frame: Within 3 weeks before the end of the therapy
description: TheSF36isashortquestionnairewith36itemswhichmeasureeightmulti-itemvariables:physicalfunctioning(10items),socialfunctioning(twoitems),rolelimitationsduetophysicalproblems(fouritems),rolelimitationsduetoemotionalproblems(threeitems),mentalhealth(fiveitems),energyandvitality(fouritems),pain(twoitems),andgeneralperceptionofhealth(fiveitems).Foreachvariableitemscoresarecoded,summed,andtransformedontoascalefrom0(worstpossiblehealthstatemeasuredbythequestionnaire)to100(bestpossiblehealthstate).
measure: Childhood Trauma Questionnaire (CTQ)
time frame: Before the therapy begins, at day 0
description: The Childhood Trauma Questionnaire (CTQ) is a questionnaire developed by Bernstein et al. (1994) that includes 70 items with a Likert scale in five response choices (from 1 = "never true" to 5 = "very often true").
measure: Childhood Trauma Questionnaire (CTQ)
time frame: Within 3 weeks before the end of the therapy
description: The Childhood Trauma Questionnaire (CTQ) is a questionnaire developed by Bernstein et al. (1994) that includes 70 items with a Likert scale in five response choices (from 1 = "never true" to 5 = "very often true").
measure: Clinician Administered PTSD Scale for DSM-5[CAPS-5])
time frame: Before the therapy begins, at day 0
description: he CAPS-5 is a 30-item structured interview that can be used to:
Make current (past month) diagnosis of PTSD,Make lifetime diagnosis of PTSD, Assess PTSD symptoms over the past week
measure: Clinician Administered PTSD Scale for DSM-5[CAPS-5])
time frame: Within 3 weeks before the end of the therapy
description: he CAPS-5 is a 30-item structured interview that can be used to:
Make current (past month) diagnosis of PTSD,Make lifetime diagnosis of PTSD, Assess PTSD symptoms over the past week
measure: Clinical Global Impression (CGI)
time frame: Before the therapy begins, at day 0
description: The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
measure: Clinical Global Impression (CGI)
time frame: Within 3 weeks before the end of the therapy
description: The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
arm group label: Patient for Eye Movement desensitization Reprocessing therapy
arm group type: Active Comparator
description: Patient with post-traumatic Stress Disorder will receive Eye Movement Desensitization reprocessing therapy
arm group label: patients for Trauma-Centred Cognitive and Behavioural Therapy
arm group type: Placebo Comparator
description: Patients with post-traumatic Stress Disorder will receive Trauma-Centred Cognitive and Behavioural Therapy
intervention type: Other
intervention name: Eye Movement Desensitization Reprocessing therapy
description: The Eye Movement Desensitization Reprocessing therapy uses bi-alternating (right-left) sensory stimulation through eye movements. The patient follows the therapist's fingers from right to left in front of his eyes and also by auditory stimuli. The patient wears a helmet that alternately makes him hear a sound to the right, then to the left or touch the patient holds in his hands buzzers that alternately vibrate from right to left, or alternatively the therapist taps the patient's knees or the back of his hands.
arm group label: Patient for Eye Movement desensitization Reprocessing therapy
other name: EMDR
intervention type: Behavioral
intervention name: Trauma-Centred Cognitive and Behavioural Therapy
description: A CBT is a short, scientifically validated therapy that focuses on the interactions between thoughts, emotions and behaviours. These therapies focus on the current problems of the person, while taking into account their historical causes. They help gradually overcome disabling symptoms and aim to strengthen adaptive behaviours. A CBT relies on different techniques that help the patient to identify the mechanisms at the origin of his difficulties, to experiment with new behaviors and thus to gradually come out of vicious circles that perpetuate and aggravate the psychic suffering.
arm group label: patients for Trauma-Centred Cognitive and Behavioural Therapy
other name: CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dominique Januel, MBBS
role: Principal Investigator
affiliation: CHVille Evrard
last name: Rusheenthira THAVASEELAN, Msc
phone: 0143093232
email: r.thavaseelan@epsve.fr
last name: Youcef BENCHERIF, MSC
phone: 0143093232
email: y.bencherif@epsve.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre hospitalier de Ville-Evrard, France
investigator full name: Januel
investigator title: Head of the clinical research department (psychiatrist)
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic