<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/NCT04473118</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-05-017</org_study_id>
    <nct_id>NCT04473118</nct_id>
  </id_info>
  <brief_title>Assessment of Mental Health in Healthcare Workers Exposed to COVID-19 Patients</brief_title>
  <acronym>BADS-PTSD</acronym>
  <official_title>Burnout, Anxiety, Depression, Stress (BADS) and Post-Trauma Stress Disorder (PTSD) in Healthcare Workers Exposed to COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamad Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamad Medical Corporation</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 recent COVID-19 outbreak has put the health care workers on the frontline to interact and&#xD;
      provide support to the patients. Based on previous disease outbreak-associated studies, it is&#xD;
      evident that these individuals are at a high-risk of developing psychological distress such&#xD;
      as burnout, anxiety, depression, and stress (BADS). Thus, the current study aims to evaluate&#xD;
      the mental health outcomes of healthcare workers dealing with COVID-19 patients within Qatar&#xD;
      and internationally, during and after the COVID-19 crisis. The participants will be divided&#xD;
      into two groups: those working with COVID-19 patients and those not working with COVID-19&#xD;
      patients. The magnitude of symptoms of BADS will be assessed using electronic versions of the&#xD;
      standardized questionnaires: Maslach Burnout Inventory (MBI-HSS), Hospital Anxiety and&#xD;
      Depression Scale (HADS), Depression, Anxiety and Stress Scale (DASS-21), and Conditions for&#xD;
      Work Effectiveness (CWEQ). A follow-up survey will be sent to both groups after the COVID-19&#xD;
      crisis to assess their vulnerability to develop post-trauma stress disorder (PTSD) using a&#xD;
      PDS-5 survey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronaviruses belong to a large family of viruses, responsible for causing mild respiratory&#xD;
      infections such as the common cold or severe syndromes such as the Middle East Respiratory&#xD;
      Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS). A novel coronavirus named severe&#xD;
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the most recent&#xD;
      disease outbreak called COVID-19 that originated in Wuhan, China in December 2019. The&#xD;
      outbreak rapidly spread to other parts of China and the world, including Qatar. As of 4th&#xD;
      March 2020, the total number of confirmed cases in Qatar is 1325 and worldwide is 1,169,262.&#xD;
      On 11 March 2020, the World Health Organization had declared COVID-19 as a global pandemic.&#xD;
&#xD;
      The health care workers are on the frontline providing routine and essential services to the&#xD;
      COVID-19 patients, including diagnosis, treatment, and care. Consequently, these individuals&#xD;
      are at a high risk of developing and experiencing psychological distress. Considering the&#xD;
      continuously increasing suspected and confirmed COVID-19 cases, lack of specific treatment,&#xD;
      inadequate personal protective equipment and the need for meticulous nursing care, the health&#xD;
      care workers are overburdened mentally and are prone to mental illnesses. Not to mention, the&#xD;
      risk of themselves getting infected due to direct exposure to patients and subsequent&#xD;
      self-isolation they must undertake to prevent the spread to their own families, contribute to&#xD;
      their mental burden. Undoubtedly, health care workers are working in a stressful environment&#xD;
      that makes them susceptible to burnout syndrome, anxiety, depression, and stress (BADS).&#xD;
      Burnout syndrome itself can cause emotional instability, feeling of failure, difficulty in&#xD;
      making commitments, and an urge to resign (Maslach et al. 2001).&#xD;
&#xD;
      Several studies reported the psychological impact of the 2003 SARS outbreak among health care&#xD;
      workers. The hospital staff experienced the fear of contagion and of spreading the infection&#xD;
      to their own family, friends, and co-workers (Maunder et al. 2003, Nickell et al. 2004).&#xD;
      Stigmatization and uncertainty were prominent among these individuals (Maunder et al. 2003,&#xD;
      Bai et al. 2004). A recent study by Lai et al. (2019) assessing the mental health outcomes of&#xD;
      health care workers exposed to COVID-19 patients in Wuhan, China showed that these&#xD;
      individuals reported symptoms of anxiety, depression, distress, and insomnia. Notably, these&#xD;
      symptoms were adversely severe in nurses and frontline health care workers in comparison to&#xD;
      other health care workers. These studies highlight the psychosocial morbidity of disease&#xD;
      outbreaks and stress on the need for assessing the psychosocial impact of COVID-19 on health&#xD;
      care workers. Furthermore, conducting longitudinal studies are also essential to determine&#xD;
      the long-term psychological impact of such outbreaks on health care workers and to identify&#xD;
      factors that increase their vulnerability. Such studies will also allow us to assess and&#xD;
      develop coping strategies and effective psychosocial support programs to prepare the health&#xD;
      care workers for challenges produced by future outbreaks of such nature.&#xD;
&#xD;
      The current study aims to evaluate the mental health outcomes of healthcare workers who are&#xD;
      on the frontline of dealing with COVID-19 patients compared to non-COVID-19 patients. We aim&#xD;
      to assess the magnitude of symptoms of burnout, depression, anxiety, stress (BADS) and the&#xD;
      vulnerability to post-traumatic stress disorder (PTSD) by using established survey-based&#xD;
      tools during and after the COVID-19 crisis and performing statistical analysis of the data&#xD;
      obtained. The participants include healthcare staff working with COVID-19 patients and those&#xD;
      not working with COVID-19 patients as controls, inside and outside Qatar. The study is also&#xD;
      expected to be extended internally to assess the psychological impact globally. This study is&#xD;
      highly relevant and significant considering previous reports of psychological morbidity of&#xD;
      disease outbreaks. It will allow the development of special interventions to provide&#xD;
      psychosocial support to the health care workers that would need to be implemented&#xD;
      immediately.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 11, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>To reflect the effect of COVID-19 on the burnout, anxiety, depression and stress levels of healthcare professionals during the COVID-19 crisis</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To reflect the effect of COVID-19 on the post-trauma stress disorder levels of healthcare professionals following the COVID-19 crisis</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25000</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Healthcare workers</arm_group_label>
    <description>All healthcare workers exposed directly or not to suspected or infected COVID-19 patients such as nurse; paramedic; senior physician; resident/ trainee physician; respiratory therapist; perfusionist; physiotherapist; dietitian; technician lab; technician imaging; pharmacist; occupational therapist; speech therapist</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>An online-based questionnaire sent to participants via email</description>
    <arm_group_label>Healthcare workers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We aim to recruit around 25 thousand participants to respond to our online-based survey via&#xD;
        email. Participants will include all healthcare staff dealing with COVID-19 patients (group&#xD;
        1), vs. those who are not dealing with COVID-19 patients (group 2), from hospitals and&#xD;
        health centers inside and outside Qatar.&#xD;
&#xD;
        Our questionnaires will be used to assess their mental health by measuring burnout,&#xD;
        anxiety, depression and stress levels and post-trauma stress disorder in both groups.&#xD;
        Participants' socio-demographic data such as age, gender, profession, marital state, native&#xD;
        country, years of experience, weekly working hours will also be collected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All healthcare staff working during the COVID-19 outbreak&#xD;
&#xD;
          -  Received an email with our electronic survey&#xD;
&#xD;
          -  Accepted electronically to participate in our study&#xD;
&#xD;
          -  Completed and submitted our electronic questionnaires successfully&#xD;
&#xD;
          -  For follow-up: Accepted to receive a follow-up survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-healthcare workers&#xD;
&#xD;
          -  Did not accept electronically to participate in our study&#xD;
&#xD;
          -  Did not complete not submitted our electronic questionnaires successfully&#xD;
&#xD;
          -  For follow-up: Did not accept to receive a follow-up survey&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dr. Ali Ait Hssain</last_name>
    <phone>00974-77172526</phone>
    <email>a_aithssain@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hamad Medical Corporation</name>
      <address>
        <city>Doha</city>
        <country>Qatar</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Ait Hssain</last_name>
      <phone>44392488</phone>
      <email>a_aithssain@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Ali Ait Hssain</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sara Taleb</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Qatar</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamad Medical Corporation</investigator_affiliation>
    <investigator_full_name>Ali Ait Hssain</investigator_full_name>
    <investigator_title>Senior consultant intensivist</investigator_title>
  </responsible_party>
  <keyword>Mental health</keyword>
  <keyword>Burnout</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Stress</keyword>
  <keyword>Post-trauma stress disorder</keyword>
  <keyword>Healthcare workers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04473118
org study id: MRC-05-017
nct id: NCT04473118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The recent COVID-19 outbreak has put the health care workers on the frontline to interact and
      provide support to the patients. Based on previous disease outbreak-associated studies, it is
      evident that these individuals are at a high-risk of developing psychological distress such
      as burnout, anxiety, depression, and stress (BADS). Thus, the current study aims to evaluate
      the mental health outcomes of healthcare workers dealing with COVID-19 patients within Qatar
      and internationally, during and after the COVID-19 crisis. The participants will be divided
      into two groups: those working with COVID-19 patients and those not working with COVID-19
      patients. The magnitude of symptoms of BADS will be assessed using electronic versions of the
      standardized questionnaires: Maslach Burnout Inventory (MBI-HSS), Hospital Anxiety and
      Depression Scale (HADS), Depression, Anxiety and Stress Scale (DASS-21), and Conditions for
      Work Effectiveness (CWEQ). A follow-up survey will be sent to both groups after the COVID-19
      crisis to assess their vulnerability to develop post-trauma stress disorder (PTSD) using a
      PDS-5 survey.
Coronaviruses belong to a large family of viruses, responsible for causing mild respiratory
      infections such as the common cold or severe syndromes such as the Middle East Respiratory
      Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS). A novel coronavirus named severe
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the most recent
      disease outbreak called COVID-19 that originated in Wuhan, China in December 2019. The
      outbreak rapidly spread to other parts of China and the world, including Qatar. As of 4th
      March 2020, the total number of confirmed cases in Qatar is 1325 and worldwide is 1,169,262.
      On 11 March 2020, the World Health Organization had declared COVID-19 as a global pandemic.

      The health care workers are on the frontline providing routine and essential services to the
      COVID-19 patients, including diagnosis, treatment, and care. Consequently, these individuals
      are at a high risk of developing and experiencing psychological distress. Considering the
      continuously increasing suspected and confirmed COVID-19 cases, lack of specific treatment,
      inadequate personal protective equipment and the need for meticulous nursing care, the health
      care workers are overburdened mentally and are prone to mental illnesses. Not to mention, the
      risk of themselves getting infected due to direct exposure to patients and subsequent
      self-isolation they must undertake to prevent the spread to their own families, contribute to
      their mental burden. Undoubtedly, health care workers are working in a stressful environment
      that makes them susceptible to burnout syndrome, anxiety, depression, and stress (BADS).
      Burnout syndrome itself can cause emotional instability, feeling of failure, difficulty in
      making commitments, and an urge to resign (Maslach et al. 2001).

      Several studies reported the psychological impact of the 2003 SARS outbreak among health care
      workers. The hospital staff experienced the fear of contagion and of spreading the infection
      to their own family, friends, and co-workers (Maunder et al. 2003, Nickell et al. 2004).
      Stigmatization and uncertainty were prominent among these individuals (Maunder et al. 2003,
      Bai et al. 2004). A recent study by Lai et al. (2019) assessing the mental health outcomes of
      health care workers exposed to COVID-19 patients in Wuhan, China showed that these
      individuals reported symptoms of anxiety, depression, distress, and insomnia. Notably, these
      symptoms were adversely severe in nurses and frontline health care workers in comparison to
      other health care workers. These studies highlight the psychosocial morbidity of disease
      outbreaks and stress on the need for assessing the psychosocial impact of COVID-19 on health
      care workers. Furthermore, conducting longitudinal studies are also essential to determine
      the long-term psychological impact of such outbreaks on health care workers and to identify
      factors that increase their vulnerability. Such studies will also allow us to assess and
      develop coping strategies and effective psychosocial support programs to prepare the health
      care workers for challenges produced by future outbreaks of such nature.

      The current study aims to evaluate the mental health outcomes of healthcare workers who are
      on the frontline of dealing with COVID-19 patients compared to non-COVID-19 patients. We aim
      to assess the magnitude of symptoms of burnout, depression, anxiety, stress (BADS) and the
      vulnerability to post-traumatic stress disorder (PTSD) by using established survey-based
      tools during and after the COVID-19 crisis and performing statistical analysis of the data
      obtained. The participants include healthcare staff working with COVID-19 patients and those
      not working with COVID-19 patients as controls, inside and outside Qatar. The study is also
      expected to be extended internally to assess the psychological impact globally. This study is
      highly relevant and significant considering previous reports of psychological morbidity of
      disease outbreaks. It will allow the development of special interventions to provide
      psychosocial support to the health care workers that would need to be implemented
      immediately.
observational model: Cohort
time perspective: Prospective
measure: To reflect the effect of COVID-19 on the burnout, anxiety, depression and stress levels of healthcare professionals during the COVID-19 crisis
time frame: 6 months
measure: To reflect the effect of COVID-19 on the post-trauma stress disorder levels of healthcare professionals following the COVID-19 crisis
time frame: 9 months
arm group label: Healthcare workers
description: All healthcare workers exposed directly or not to suspected or infected COVID-19 patients such as nurse; paramedic; senior physician; resident/ trainee physician; respiratory therapist; perfusionist; physiotherapist; dietitian; technician lab; technician imaging; pharmacist; occupational therapist; speech therapist
intervention type: Other
intervention name: Survey
description: An online-based questionnaire sent to participants via email
arm group label: Healthcare workers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Ali Ait Hssain
phone: 00974-77172526
email: a_aithssain@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Qatar
responsible party type: Principal Investigator
investigator affiliation: Hamad Medical Corporation
investigator full name: Ali Ait Hssain
investigator title: Senior consultant intensivist
mesh term: COVID-19
sharing ipd: Undecided