<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/NCT03756545</url>
  </required_header>
  <id_info>
    <org_study_id>0207-14-TLV</org_study_id>
    <secondary_id>R01MH103287</secondary_id>
    <nct_id>NCT03756545</nct_id>
  </id_info>
  <brief_title>Neurobehavioral Moderators of Post-traumatic Disease Trajectories</brief_title>
  <official_title>Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</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 research goal is to uncover the neurocognitive moderators of PTSD trajectories, by&#xD;
      documenting clinical symptoms, cognitive functioning, and brain structure and function, one-,&#xD;
      six- and fourteen months following a traumatic event, in a large population of survivors at&#xD;
      initial high risk for PTSD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2015</start_date>
  <completion_date type="Actual">March 11, 2020</completion_date>
  <primary_completion_date type="Actual">March 11, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>14 Months</target_duration>
  <primary_outcome>
    <measure>Change in CAPS Total Scores</measure>
    <time_frame>one-, six- and fourteen months following a traumatic event</time_frame>
    <description>The Clinician-Administered PTSD Scale, used to assess PTSD diagnostic status and symptom severity. CAPS total symptom severity score is calculated by summing severity scores for all PTSD symptoms. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5).</description>
  </primary_outcome>
  <enrollment type="Actual">173</enrollment>
  <condition>PTSD</condition>
  <condition>Trauma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult civilians admitted to Tel-Aviv Sourasky Medical Center's Emergency Room (ER),&#xD;
        following a potentially traumatic incident. The initial screening will be done via&#xD;
        telephone-based structured interviews within 10 days of ER admission, in order to confirm&#xD;
        the occurrence of psychologically traumatic event, identify &amp; assess those expressing&#xD;
        initial Acute Stress Disorder (ASD) symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 - 65 years&#xD;
&#xD;
          -  Able to read and comprehend Hebrew&#xD;
&#xD;
          -  Arrived in the ER because of one of the following: car accidents, terrorist attacks,&#xD;
             work accidents, home accidents, burns, physical assault, large-scale disaster.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with known claustrophobia&#xD;
&#xD;
          -  Individuals with history of substance abuse&#xD;
&#xD;
          -  Individuals with current or past psychotic or bipolar I disorder&#xD;
&#xD;
          -  Individuals with chronic PTSD at the time of the current trauma&#xD;
&#xD;
          -  Individuals on psychotropic medication or recreational drugs in the week that precedes&#xD;
             the MRI&#xD;
&#xD;
          -  Individuals with hearing problems&#xD;
&#xD;
          -  Individuals with head trauma with coma exceeding 30 minutes&#xD;
&#xD;
          -  Individuals which can't perform MRI due to safety reasons (e.g. irremovable metals in&#xD;
             their 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>Arieh Y Shalev, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, NYU Langone Medical Center, New York, NY, United States</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
    <investigator_full_name>michal roll</investigator_full_name>
    <investigator_title>Prof. Talma Hendler</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT03756545
org study id: 0207-14-TLV
secondary id: R01MH103287
nct id: NCT03756545
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by
      documenting clinical symptoms, cognitive functioning, and brain structure and function, one-,
      six- and fourteen months following a traumatic event, in a large population of survivors at
      initial high risk for PTSD.
observational model: Cohort
time perspective: Prospective
measure: Change in CAPS Total Scores
time frame: one-, six- and fourteen months following a traumatic event
description: The Clinician-Administered PTSD Scale, used to assess PTSD diagnostic status and symptom severity. CAPS total symptom severity score is calculated by summing severity scores for all PTSD symptoms. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Arieh Y Shalev, Prof.
role: Principal Investigator
affiliation: Department of Psychiatry, NYU Langone Medical Center, New York, NY, United States
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel-Aviv Sourasky Medical Center
investigator full name: michal roll
investigator title: Prof. Talma Hendler
mesh term: Wounds and Injuries