<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/NCT04506632</url>
  </required_header>
  <id_info>
    <org_study_id>STH21373</org_study_id>
    <nct_id>NCT04506632</nct_id>
  </id_info>
  <brief_title>Burden for STaff Working in the NHS</brief_title>
  <acronym>COST-NHS</acronym>
  <official_title>COST-NHS: COvid Burden in STaff Working in the NHS: A Study to Assess the Mental Health Burden of the COVID-19 Pandemic on NHS Healthcare Staff</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</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 COVID-19 crisis began in China in December 2019 and was declared a pandemic by the World&#xD;
      Health Organisation on March 11th 2020. The pandemic has changed the way that clinicians&#xD;
      interact with and treat patients overnight. Staff within the NHS will be under high levels of&#xD;
      stress due to the increased needs and worse outcomes of work as they are shielding or&#xD;
      self-isolating and may feel helpless and guilty. The psychological impact of the pandemic&#xD;
      will be prolonged and varied. It is vital that Investigators increase understanding as much&#xD;
      as possible to support NHS staff.&#xD;
&#xD;
      The aim of this survey is to examine the possible mental health burden on NHS staff as a&#xD;
      result of the COVID-19 pandemic and how these change as the pandemic progresses. By&#xD;
      understanding these effects, it will allow researchers to identify recommendations to allow&#xD;
      support mechanisms to be put in place for NHS staff, to better manage this and future&#xD;
      pandemics and similar crises.&#xD;
&#xD;
      Investigators are aiming to sample several cohorts of NHS staff including a subset of staff&#xD;
      who are shielding. Staff will be asked to complete a series of online surveys at multiple&#xD;
      timepoint: on study initiation, 1 month later and then 3 months after the pandemic has ceased&#xD;
      in the UK. Additional timepoints may be added depending on the length and severity of the&#xD;
      pandemic.&#xD;
&#xD;
      The main outcomes will be tracking changes in mental health measurements at the pre-defined&#xD;
      timepoints. This work will allow Investigators to produce recommendations about the increased&#xD;
      mental health support that NHS staff will need. If a need is demonstrated then an&#xD;
      interventional research project will be designed and implemented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this survey is to examine the possible mental health burden on NHS staff as a&#xD;
      results of the coronavirus COVID-19 pandemic and how these change as the pandemic progresses.&#xD;
      By understanding these effects, it will allow Investigators to identify recommendations to&#xD;
      allow appropriate support mechanisms to be put in place for NHS staff, to better manage this&#xD;
      and future pandemics and similar crises.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Investigators aim to sample several cohorts of staff across the NHS. A subset of participants&#xD;
      will include NHS staff that are currently shielding - they are self-isolating due to being&#xD;
      identified as part of the at-risk/vulnerable members of society. The aim will be to survey a&#xD;
      minimum of 100 members of staff. Introductory emails will be sent out to NHS staff using the&#xD;
      hospital email system. Potential participants will be asked to read a participant information&#xD;
      sheet and provide informed consent to participate in the subsequent survey.&#xD;
&#xD;
      Staff within the NHS will be asked to complete a series of surveys at multiple timepoints.&#xD;
      The survey link will be circulated to staff with the introductory email. It will be sent at&#xD;
      the following time points with a reminder to all on each occasion after 5 days: on study&#xD;
      initiation, 1 month later and then 3 months after the pandemic has ceased in the UK.&#xD;
      Additional timepoints may be added depending on the length and severity of the pandemic.&#xD;
&#xD;
      Qualtrics software will be used to host and administer the survey. The variables to be&#xD;
      measured are:&#xD;
&#xD;
      Demographics (At first survey only): Age, sex, ethnic status, socio-economical status,&#xD;
      religious identification and occupation.&#xD;
&#xD;
      Exposure to COVID-19 Mental health: The investigators will assess depression with 9 items&#xD;
      (PHQ-9); anxiety with 7 items (GAD-7); paranoia (short Green paranoia scale), traumatic&#xD;
      stress, somatic symptoms (PHQ-15); conspiracy mentality and social interactions (The&#xD;
      loneliness scale).&#xD;
&#xD;
      Mediating psychological variables: Locus of control, death anxiety, 10 item Cognitive&#xD;
      Reflection Task of analytical reasoning and personality traits 9 Big-five short version.&#xD;
&#xD;
      The surveys should take approximately 10 minutes to complete. Participants will be informed&#xD;
      that should they feel distressed by the questions raised in the survey, that they should seek&#xD;
      support from the providers in the introductory email. Participants will be able to withdraw&#xD;
      from the study and any timepoint without providing a reason.&#xD;
&#xD;
      The participants anonymised data will be analysed by Professor Bentall's team at the&#xD;
      University of Sheffield and stored on a secure, University server. The main outcomes of the&#xD;
      study will be tracking changes in mental health measurements at the pre-defined timepoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">November 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Depression</measure>
    <time_frame>UP to 3 months after the pandemic ends in the UK</time_frame>
    <description>We will assess depression with 9 items (PHQ-9);</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Anxiety</measure>
    <time_frame>UP to 3 months after the pandemic ends in the UK</time_frame>
    <description>measured by GAD-7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in feelings of paranoia</measure>
    <time_frame>UP to 3 months after the pandemic ends in the UK</time_frame>
    <description>measured by the short Green paranoia scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Traumatic Stress</measure>
    <time_frame>UP to 3 months after the pandemic ends in the UK</time_frame>
    <description>As measured by PHQ-15</description>
  </primary_outcome>
  <primary_outcome>
    <measure>conspiracy mentality and social interactions</measure>
    <time_frame>UP to 3 months after the pandemic ends in the UK</time_frame>
    <description>as measured by the loneliness scale</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID-19</condition>
  <condition>Mental Health Burden</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will recruit NHS staff that are working during the COVID-19 pandemic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 16 years or over&#xD;
&#xD;
          -  Participants must be working in the NHS&#xD;
&#xD;
          -  NHS staff that are shielding will be eligible to participate&#xD;
&#xD;
          -  NHS staff that are self-isolating will be eligible to participate&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Participants will not be excluded on any other basis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Danson, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Colette Mann</last_name>
    <phone>0114 226 5208</phone>
    <email>colette_mann@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Loretta Chantry-Groves</last_name>
    <phone>0114 226 5208</phone>
    <email>loretta.chantry-groves@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 1SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colette Mann</last_name>
      <phone>0114 226 5208</phone>
      <email>colette.mann@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Loretta Chantry-Groves</last_name>
      <phone>0114 226 5208</phone>
      <email>loretta.chantry-groves@nhs.net</email>
    </contact_backup>
    <investigator>
      <last_name>Sarah Danson, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 21, 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>June 7, 2022</last_update_submitted>
  <last_update_submitted_qc>June 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>NHS staff</keyword>
  <keyword>Mental health</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>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/NCT04506632
org study id: STH21373
nct id: NCT04506632
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COVID-19 crisis began in China in December 2019 and was declared a pandemic by the World
      Health Organisation on March 11th 2020. The pandemic has changed the way that clinicians
      interact with and treat patients overnight. Staff within the NHS will be under high levels of
      stress due to the increased needs and worse outcomes of work as they are shielding or
      self-isolating and may feel helpless and guilty. The psychological impact of the pandemic
      will be prolonged and varied. It is vital that Investigators increase understanding as much
      as possible to support NHS staff.

      The aim of this survey is to examine the possible mental health burden on NHS staff as a
      result of the COVID-19 pandemic and how these change as the pandemic progresses. By
      understanding these effects, it will allow researchers to identify recommendations to allow
      support mechanisms to be put in place for NHS staff, to better manage this and future
      pandemics and similar crises.

      Investigators are aiming to sample several cohorts of NHS staff including a subset of staff
      who are shielding. Staff will be asked to complete a series of online surveys at multiple
      timepoint: on study initiation, 1 month later and then 3 months after the pandemic has ceased
      in the UK. Additional timepoints may be added depending on the length and severity of the
      pandemic.

      The main outcomes will be tracking changes in mental health measurements at the pre-defined
      timepoints. This work will allow Investigators to produce recommendations about the increased
      mental health support that NHS staff will need. If a need is demonstrated then an
      interventional research project will be designed and implemented.
The aim of this survey is to examine the possible mental health burden on NHS staff as a
      results of the coronavirus COVID-19 pandemic and how these change as the pandemic progresses.
      By understanding these effects, it will allow Investigators to identify recommendations to
      allow appropriate support mechanisms to be put in place for NHS staff, to better manage this
      and future pandemics and similar crises.

      Method:

      Investigators aim to sample several cohorts of staff across the NHS. A subset of participants
      will include NHS staff that are currently shielding - they are self-isolating due to being
      identified as part of the at-risk/vulnerable members of society. The aim will be to survey a
      minimum of 100 members of staff. Introductory emails will be sent out to NHS staff using the
      hospital email system. Potential participants will be asked to read a participant information
      sheet and provide informed consent to participate in the subsequent survey.

      Staff within the NHS will be asked to complete a series of surveys at multiple timepoints.
      The survey link will be circulated to staff with the introductory email. It will be sent at
      the following time points with a reminder to all on each occasion after 5 days: on study
      initiation, 1 month later and then 3 months after the pandemic has ceased in the UK.
      Additional timepoints may be added depending on the length and severity of the pandemic.

      Qualtrics software will be used to host and administer the survey. The variables to be
      measured are:

      Demographics (At first survey only): Age, sex, ethnic status, socio-economical status,
      religious identification and occupation.

      Exposure to COVID-19 Mental health: The investigators will assess depression with 9 items
      (PHQ-9); anxiety with 7 items (GAD-7); paranoia (short Green paranoia scale), traumatic
      stress, somatic symptoms (PHQ-15); conspiracy mentality and social interactions (The
      loneliness scale).

      Mediating psychological variables: Locus of control, death anxiety, 10 item Cognitive
      Reflection Task of analytical reasoning and personality traits 9 Big-five short version.

      The surveys should take approximately 10 minutes to complete. Participants will be informed
      that should they feel distressed by the questions raised in the survey, that they should seek
      support from the providers in the introductory email. Participants will be able to withdraw
      from the study and any timepoint without providing a reason.

      The participants anonymised data will be analysed by Professor Bentall's team at the
      University of Sheffield and stored on a secure, University server. The main outcomes of the
      study will be tracking changes in mental health measurements at the pre-defined timepoints.
observational model: Ecologic or Community
time perspective: Prospective
measure: Changes in Depression
time frame: UP to 3 months after the pandemic ends in the UK
description: We will assess depression with 9 items (PHQ-9);
measure: Changes in Anxiety
time frame: UP to 3 months after the pandemic ends in the UK
description: measured by GAD-7
measure: Changes in feelings of paranoia
time frame: UP to 3 months after the pandemic ends in the UK
description: measured by the short Green paranoia scale
measure: Traumatic Stress
time frame: UP to 3 months after the pandemic ends in the UK
description: As measured by PHQ-15
measure: conspiracy mentality and social interactions
time frame: UP to 3 months after the pandemic ends in the UK
description: as measured by the loneliness scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Danson, Professor
role: Study Director
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
last name: Colette Mann
phone: 0114 226 5208
email: colette_mann@nhs.net
last name: Loretta Chantry-Groves
phone: 0114 226 5208
email: loretta.chantry-groves@nhs.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No