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/NCT06007612</url>
    </required_header>
    <id_info>
      <org_study_id>Sheppes02</org_study_id>
      <nct_id>NCT06007612</nct_id>
    </id_info>
    <brief_title>Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder</brief_title>
    <official_title>Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gal Sheppes</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tel Aviv University</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 study will examine context sensitivity, composed of two sequential elements: (a)&#xD;
        accurate classification of changing affective contextual demands, followed by (b) flexible&#xD;
        selection of regulatory strategies that matches changing contextual demands, among complex&#xD;
        PTSD vs. Healthy controls.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will recruit adults with posttraumatic stress disorder (PTSD) due to a repetitive&#xD;
        inter-personal trauma and healthy adult controls which do not meet DSM-5 criteria for PTSD&#xD;
        and do not meet the clinical cutoff of Anxiety and Depression screening questionnaires.&#xD;
  &#xD;
        A compatibility check, filtering, verification of exclusion criteria and informed consent&#xD;
        will occur via online self-report questionnaires.&#xD;
  &#xD;
        Clinical questioners include:&#xD;
  &#xD;
        Life event Checklist (LEC) - PTSD criteria A Post-trauma Checklist for DSM-5 (PCL) - PTSD&#xD;
        symptoms Patient Health Questionnaire (PHQ-9) - Depression Symptoms General Anxiety Disorder&#xD;
        Questioner (GAD-7) - Anxiety Symptoms&#xD;
  &#xD;
        Participants who pass the initial filtering, will be called and provided with an explanation&#xD;
        about the study following which they received the online experiment.&#xD;
  &#xD;
        Modified regulatory selection flexibility paradigm- included 3 blocks:&#xD;
  &#xD;
        (A) Stimuli Classification- 80 emotional words (equally distributed between high or low&#xD;
        intensities) are presented and participants are asked classify each emotional word to high or&#xD;
        low intensity.&#xD;
  &#xD;
        (B) Regulatory Selection- 40 emotional words (out of the 80 presented in block A) are&#xD;
        presented and participants are instructed to behaviorally choose between distraction and&#xD;
        reappraisal.&#xD;
  &#xD;
        (B) Regulatory Selection- 40 emotional words (the 40 remaining from block A) are presented,&#xD;
        prior to regulatory selection, participants received accurate normed intensity classification&#xD;
        of the word and then participants are instructed to behaviorally choose between distraction&#xD;
        and reappraisal.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 13, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>2 groups enrolled in a one-time behavioral paradigm</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Difference in accurate intensity classification measured during Block A of the experiment</measure>
      <time_frame>During the experimental task (1 hour)</time_frame>
      <description>comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm</measure>
      <time_frame>During the experimental task (1 hour)</time_frame>
      <description>group comparison of the association between accuracy in intensity classification (as measured in Block A) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block B.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>regulatory selection flexibility (measured by distraction choice in high intensity minus distraction choice in low intensity) following provided intensity as assessed by regulatory selection paradigm</measure>
      <time_frame>During the experimental task (1 hour)</time_frame>
      <description>group comparison of the association between provided intensity classification (i.e., whether stimuli is of high or low intensity) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block C</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Complex Post-Traumatic Stress Disorder</condition>
    <arm_group>
      <arm_group_label>Behavioral: Context Sensitivity in Emotion Regulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Context Sensitivity in Emotion Regulation</intervention_name>
      <description>Context Sensitivity of affective intensities and its association to Emotion Regulation Flexibility Selection</description>
      <arm_group_label>Behavioral: Context Sensitivity in Emotion Regulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Native Hebrew speakers&#xD;
  &#xD;
            -  age between 18 - 65&#xD;
  &#xD;
            -  normal or corrected to normal vision&#xD;
  &#xD;
            -  computer and internet access&#xD;
  &#xD;
            -  Group 1: Diagnosis of PTSD according to the DSM-5&#xD;
  &#xD;
            -  Group 2: GAD and PHQ scores (score&lt;10), no diagnosis of PTSD according to the DSM-5&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Psychosis&#xD;
  &#xD;
            -  substance dependence or abuse other than nicotine&#xD;
  &#xD;
            -  Neurological condition&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tel Aviv University</name>
        <address>
          <city>Tel Aviv</city>
          <zip>6997801</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gal Sheppes, PhD</last_name>
        <phone>972-3-6408977</phone>
        <email>gsheppes@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Naomi B Fine, PhD</last_name>
        <phone>0528681031</phone>
        <email>naomifine@mail.tau.ac.il</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tel Aviv University</investigator_affiliation>
      <investigator_full_name>Gal Sheppes</investigator_full_name>
      <investigator_title>Principal Investigator of Emotion Regulation Lab</investigator_title>
    </responsible_party>
    <keyword>EMOTION REGULATION</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>
    <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/NCT06007612
  org study id: Sheppes02
  nct id: NCT06007612
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will examine context sensitivity, composed of two sequential elements: (a)
        accurate classification of changing affective contextual demands, followed by (b) flexible
        selection of regulatory strategies that matches changing contextual demands, among complex
        PTSD vs. Healthy controls.
  The study will recruit adults with posttraumatic stress disorder (PTSD) due to a repetitive
        inter-personal trauma and healthy adult controls which do not meet DSM-5 criteria for PTSD
        and do not meet the clinical cutoff of Anxiety and Depression screening questionnaires.
  
        A compatibility check, filtering, verification of exclusion criteria and informed consent
        will occur via online self-report questionnaires.
  
        Clinical questioners include:
  
        Life event Checklist (LEC) - PTSD criteria A Post-trauma Checklist for DSM-5 (PCL) - PTSD
        symptoms Patient Health Questionnaire (PHQ-9) - Depression Symptoms General Anxiety Disorder
        Questioner (GAD-7) - Anxiety Symptoms
  
        Participants who pass the initial filtering, will be called and provided with an explanation
        about the study following which they received the online experiment.
  
        Modified regulatory selection flexibility paradigm- included 3 blocks:
  
        (A) Stimuli Classification- 80 emotional words (equally distributed between high or low
        intensities) are presented and participants are asked classify each emotional word to high or
        low intensity.
  
        (B) Regulatory Selection- 40 emotional words (out of the 80 presented in block A) are
        presented and participants are instructed to behaviorally choose between distraction and
        reappraisal.
  
        (B) Regulatory Selection- 40 emotional words (the 40 remaining from block A) are presented,
        prior to regulatory selection, participants received accurate normed intensity classification
        of the word and then participants are instructed to behaviorally choose between distraction
        and reappraisal.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: 2 groups enrolled in a one-time behavioral paradigm
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Difference in accurate intensity classification measured during Block A of the experiment
  time frame: During the experimental task (1 hour)
  description: comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.
  measure: regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm
  time frame: During the experimental task (1 hour)
  description: group comparison of the association between accuracy in intensity classification (as measured in Block A) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block B.
  measure: regulatory selection flexibility (measured by distraction choice in high intensity minus distraction choice in low intensity) following provided intensity as assessed by regulatory selection paradigm
  time frame: During the experimental task (1 hour)
  description: group comparison of the association between provided intensity classification (i.e., whether stimuli is of high or low intensity) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block C
  arm group label: Behavioral: Context Sensitivity in Emotion Regulation
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Context Sensitivity in Emotion Regulation
  description: Context Sensitivity of affective intensities and its association to Emotion Regulation Flexibility Selection
  arm group label: Behavioral: Context Sensitivity in Emotion Regulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Israel
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tel Aviv University
  investigator full name: Gal Sheppes
  investigator title: Principal Investigator of Emotion Regulation Lab
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: Undecided