<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/NCT03278171</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0462</org_study_id>
    <nct_id>NCT03278171</nct_id>
  </id_info>
  <brief_title>Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit</brief_title>
  <acronym>STRESSREA</acronym>
  <official_title>Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in&#xD;
      troubles due to a traumatism or a stress factor and appearing at least 1 month after&#xD;
      confrontation with trauma. This trouble can become chronic, and be the source of psychiatric&#xD;
      and somatic comorbidities, which themselves have personal, professional and economic&#xD;
      consequences at the level of the individual and society.&#xD;
&#xD;
      Some studies looked at the psychological effects induced by a stay in intensive care unit&#xD;
      (ICU) since few years. The emergence of PTSD in these patients has been described, with an&#xD;
      incidence varying from 4% to 60%.&#xD;
&#xD;
      The literature is contradictory about identified risk factors for PTSD. It's not possible to&#xD;
      design a screening of these patients actually, only focused on the risk factors. It has been&#xD;
      shown that the presence of acute stress trouble (presence of symptoms during the first month&#xD;
      after the traumatism) was a risk factor for PTSD. Early detection of acute stress disorder&#xD;
      could be a way to screen risk of emergence of a post-intensive care PTSD. Post-intensive care&#xD;
      consultations have been done at 6 months, but not systematically. Only few symptoms are&#xD;
      looked for and a sizable part of this population were not being followed probably due to a&#xD;
      non-diagnosed-PTSD. In case of the emergence of a post-intensive care PTSD, those patients&#xD;
      will never be diagnosed and treated, favoring all complications linked to this trouble.&#xD;
&#xD;
      Associated with other factors, IES-R (Impact Event Scale Revisited) at the ICU exit would&#xD;
      permit an exhaustive screening of patients at risk for PTSD and could permit to propose them&#xD;
      an adapted care and then limit the emergence of PTSD and its consequences..&#xD;
&#xD;
      In this study, the investigators will screen acute stress symptoms within 8 days following&#xD;
      the ICU's exit, using the IES-R, in order to evaluate his ability to predict the emergence of&#xD;
      a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics&#xD;
      capacities for PTSD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">July 10, 2018</completion_date>
  <primary_completion_date type="Actual">July 10, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Impact Event Scale Revisited</measure>
    <time_frame>3 months</time_frame>
    <description>Impact Event Scale Revisited (IES-R) will be carried out by a psychiatry clinician within 8 days following the intensive care unit in order to evaluate his ability to predict the emergence of a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics capacities for PTSD.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">208</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Patients in intensive care unit</arm_group_label>
    <description>Cohort of patients leaving intensive care unit after a stay of more than 72 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Impact Event Scale Revisited</intervention_name>
    <description>Evaluating the ability of the Impact Event Scale -Revisited within 8 days following the intensive care unit exit to predict a post-traumatic stress disorder at 3 months (Impact Event Scale -Revisited score strictly greater than 34)</description>
    <arm_group_label>Patients in intensive care unit</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People over 18 years old, staying more than 72 hours in intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years old leaving an intensive care unit after a stay of more than 72&#xD;
             hours, in one of the medical and surgical intensive care units of the E Herriot&#xD;
             Hospital&#xD;
&#xD;
          -  Patient having given his agreement to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not understanding French language&#xD;
&#xD;
          -  Confused patient (clinical assessment)&#xD;
&#xD;
          -  Patient under protection measure or deprived from his rights&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Psychiatrie des urgences, Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69423</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 21, 2018</last_update_submitted>
  <last_update_submitted_qc>September 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>No</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/NCT03278171
org study id: 69HCL17_0462
nct id: NCT03278171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in
      troubles due to a traumatism or a stress factor and appearing at least 1 month after
      confrontation with trauma. This trouble can become chronic, and be the source of psychiatric
      and somatic comorbidities, which themselves have personal, professional and economic
      consequences at the level of the individual and society.

      Some studies looked at the psychological effects induced by a stay in intensive care unit
      (ICU) since few years. The emergence of PTSD in these patients has been described, with an
      incidence varying from 4% to 60%.

      The literature is contradictory about identified risk factors for PTSD. It's not possible to
      design a screening of these patients actually, only focused on the risk factors. It has been
      shown that the presence of acute stress trouble (presence of symptoms during the first month
      after the traumatism) was a risk factor for PTSD. Early detection of acute stress disorder
      could be a way to screen risk of emergence of a post-intensive care PTSD. Post-intensive care
      consultations have been done at 6 months, but not systematically. Only few symptoms are
      looked for and a sizable part of this population were not being followed probably due to a
      non-diagnosed-PTSD. In case of the emergence of a post-intensive care PTSD, those patients
      will never be diagnosed and treated, favoring all complications linked to this trouble.

      Associated with other factors, IES-R (Impact Event Scale Revisited) at the ICU exit would
      permit an exhaustive screening of patients at risk for PTSD and could permit to propose them
      an adapted care and then limit the emergence of PTSD and its consequences..

      In this study, the investigators will screen acute stress symptoms within 8 days following
      the ICU's exit, using the IES-R, in order to evaluate his ability to predict the emergence of
      a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics
      capacities for PTSD.
observational model: Cohort
time perspective: Prospective
measure: Impact Event Scale Revisited
time frame: 3 months
description: Impact Event Scale Revisited (IES-R) will be carried out by a psychiatry clinician within 8 days following the intensive care unit in order to evaluate his ability to predict the emergence of a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics capacities for PTSD.
arm group label: Patients in intensive care unit
description: Cohort of patients leaving intensive care unit after a stay of more than 72 hours
intervention type: Behavioral
intervention name: Impact Event Scale Revisited
description: Evaluating the ability of the Impact Event Scale -Revisited within 8 days following the intensive care unit exit to predict a post-traumatic stress disorder at 3 months (Impact Event Scale -Revisited score strictly greater than 34)
arm group label: Patients in intensive care unit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No