<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/NCT04506515</url>
  </required_header>
  <id_info>
    <org_study_id>COV2-2020</org_study_id>
    <nct_id>NCT04506515</nct_id>
  </id_info>
  <brief_title>Psychological Impact of COVID-19 Pandemic in Healthcare Workers</brief_title>
  <acronym>PSIMCOV</acronym>
  <official_title>Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario de Valencia</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>
      Background. The current coronavirus disease (COVID-19) has a great impact worldwide.&#xD;
      Healthcare workers play an essential role and are one of the most exposed groups.Information&#xD;
      about the psychosocial impact on healthcare workers is limited.&#xD;
&#xD;
      Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional&#xD;
      45-item survey between 9 and 19 April 2020. The objective is to assess the psychological&#xD;
      impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and&#xD;
      Adaptation at work Score (PSAS) was defined combining four modified versions of validated&#xD;
      psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies&#xD;
      Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire&#xD;
      designed to assess psychological impact in healthcare workers to match times of crisis and&#xD;
      when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent&#xD;
      higher stress detected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2020</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 19, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PSAS (Psychological Stress and Adaptation at work Score) during the crisis</measure>
    <time_frame>during the pandemic (April 9, 2020 to April 19, 2020)</time_frame>
    <description>evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSAS (Psychological Stress and Adaptation at work Score) in basal conditions</measure>
    <time_frame>After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.</time_frame>
    <description>evaluate the psychological stress in Spain in healthcare workers</description>
  </secondary_outcome>
  <enrollment type="Actual">3000</enrollment>
  <condition>Covid19</condition>
  <condition>Stress, Psychological</condition>
  <condition>Work Related Stress</condition>
  <condition>Epidemic Disease</condition>
  <condition>SARS-CoV Infection</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Psychological stress and adaptation at work score (PSAS)</intervention_name>
    <description>completing a survey based on PSAS</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Respondents are healthcare workers in any center/hospital treating patients and are&#xD;
        involved directly or indirectily with patients who suffer from COVID-19.&#xD;
&#xD;
        Respondents might be physicians, nurses, ancillary staff, etc or be involved in other type&#xD;
        of jobs like administration, techinical support, kitchen and cleaning servicies, etc.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active healthcare workers in any private/public hospital &gt; 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHGUV</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Romero CS, Delgado C, Catala J, Ferrer C, Errando C, Iftimi A, Benito A, de Andres J, Otero M; PSIMCOV group*. COVID-19 psychological impact in 3109 healthcare workers in Spain: The PSIMCOV group. Psychol Med. 2022 Jan;52(1):188-194. doi: 10.1017/S0033291720001671. Epub 2020 May 14.</citation>
    <PMID>32404217</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario de Valencia</investigator_affiliation>
    <investigator_full_name>Carolina Soledad Romero Garcia, MD, PhD</investigator_full_name>
    <investigator_title>Anesthesia and Critical care consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
    <mesh_term>Occupational Stress</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The investigators did not ask to the ethical committee board for data sharing approval</ipd_description>
  </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/NCT04506515
org study id: COV2-2020
nct id: NCT04506515
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background. The current coronavirus disease (COVID-19) has a great impact worldwide.
      Healthcare workers play an essential role and are one of the most exposed groups.Information
      about the psychosocial impact on healthcare workers is limited.

      Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional
      45-item survey between 9 and 19 April 2020. The objective is to assess the psychological
      impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and
      Adaptation at work Score (PSAS) was defined combining four modified versions of validated
      psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies
      Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.
PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire
      designed to assess psychological impact in healthcare workers to match times of crisis and
      when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent
      higher stress detected.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: PSAS (Psychological Stress and Adaptation at work Score) during the crisis
time frame: during the pandemic (April 9, 2020 to April 19, 2020)
description: evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers
measure: PSAS (Psychological Stress and Adaptation at work Score) in basal conditions
time frame: After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.
description: evaluate the psychological stress in Spain in healthcare workers
intervention type: Diagnostic Test
intervention name: Psychological stress and adaptation at work score (PSAS)
description: completing a survey based on PSAS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
facility: 
country: Spain
citation: Romero CS, Delgado C, Catala J, Ferrer C, Errando C, Iftimi A, Benito A, de Andres J, Otero M; PSIMCOV group*. COVID-19 psychological impact in 3109 healthcare workers in Spain: The PSIMCOV group. Psychol Med. 2022 Jan;52(1):188-194. doi: 10.1017/S0033291720001671. Epub 2020 May 14.
PMID: 32404217
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario de Valencia
investigator full name: Carolina Soledad Romero Garcia, MD, PhD
investigator title: Anesthesia and Critical care consultant
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
mesh term: Occupational Stress
mesh term: Stress, Psychological
sharing ipd: Undecided
ipd description: The investigators did not ask to the ethical committee board for data sharing approval