<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/NCT04433260</url>
  </required_header>
  <id_info>
    <org_study_id>284686</org_study_id>
    <nct_id>NCT04433260</nct_id>
  </id_info>
  <brief_title>COVID19 and Physical and Emotional Wellbeing of HCP</brief_title>
  <acronym>CoPE-HCP</acronym>
  <official_title>Immediate and Mid-term Implications of the Covid-19 Pandemic on the Physical, Behavioural and Mental Health of Healthcare Workers: A Cohort Study of Doctor, Nurses and Other Health Care Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</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 current COVID-19 pandemic has affected more than 3 million people worldwide across more&#xD;
      than 200 countries.&#xD;
&#xD;
      In the United Kingdom alone, at the end of April, there were almost 160,000 confirmed cases&#xD;
      with more than 20,000 deaths. This has undoubtedly had significant physical and economical&#xD;
      impact on the public.&#xD;
&#xD;
      Healthcare workers are at high risk of developing life-threatening infectious diseases with&#xD;
      increased exposure to patients' blood and bodily fluids. As such, health care workers&#xD;
      arguably experience heightened anxiety and are predisposed to greater negative psycho-social&#xD;
      impact from the current COVID-19 pandemic.&#xD;
&#xD;
      The aim of this study is to evaluate the physical and psychological impact of COVID-19 on&#xD;
      healthcare workers. This will be performed in two phases.&#xD;
&#xD;
      In phase 1, investigators will collect information to evaluate the current psychiatric&#xD;
      symptom profile (in particular, screening for anxiety or depression related symptoms),&#xD;
      alcohol use, sleep-related complaints and overall well-being among healthcare workers who&#xD;
      participate in this survey (with a focus on junior doctors). In addition the association of&#xD;
      these mental health and behavioural parameters with the prevalence of stressful occasions,&#xD;
      such as long-hours, unpredictability of work / redeployment, availability of personal&#xD;
      protection equipment and concerns regarding family/relationship and self will be assessed.&#xD;
&#xD;
      In phase 2, investigators will then reassess for the development or progression of&#xD;
      psychiatric symptoms, use of alcohol and other substances, behavioural or interpersonal&#xD;
      relationship changes as well as physical well-being at 6 weeks and 4- months. Physical&#xD;
      well-being is assessed through the presence of suspected or confirmed COVID-19 infection and&#xD;
      absence from work. Specifically, investigators will study the impact of variable provision of&#xD;
      personal protection equipment (supply and training), extended working hours, and concern for&#xD;
      well-being of family members, on work morale and anxiety levels.&#xD;
&#xD;
      Another aim is also study the longer term mental health consequences of the current pandemic&#xD;
      on health care workers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of anxiety at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.&#xD;
Higher score corresponding to more severe degree of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of depression at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).&#xD;
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of those who report a combined outcome of presence of anxiety or depression at the baseline as determined by screening questionnaires used.</measure>
    <time_frame>baseline</time_frame>
    <description>Anxiety will be investigated by 7-item Generalised Anxiety Disorder and depression will be investigated by 9-item patient health questionnaire. Presence of either one of those or both will be taken as the combined outcome.&#xD;
For anxiety, 7-item Generalized anxiety disorder score (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.&#xD;
Higher score corresponding to more severe degree of anxiety. For depression, the 9- item Patient Health Questionnaire (PHQ-9). Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression&#xD;
Higher score corresponding to more severe degree of anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study</measure>
    <time_frame>4 months</time_frame>
    <description>Anxiety will be investigated by 7-item Generalised Anxiety Disorder and depression will be investigated by 9-item patient health questionnaire. Presence of either one of those or both will be taken as the combined outcome.&#xD;
For anxiety, 7-item Generalized anxiety disorder score (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.&#xD;
Higher score corresponding to more severe degree of anxiety. For depression, the 9- item Patient Health Questionnaire (PHQ-9). Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19 from baseline to the end of study</measure>
    <time_frame>4 months</time_frame>
    <description>Self reported, assessed based on the questions regarding the presence of symptoms with presence of either self reported positive test, or self-isolation of 7 or more days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in prevalence of anxiety from baseline</measure>
    <time_frame>4 months</time_frame>
    <description>Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.&#xD;
Higher score corresponding to more severe degree of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in prevalence of depression from baseline</measure>
    <time_frame>4 months followup</time_frame>
    <description>Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).&#xD;
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of sleep-related issues at baseline</measure>
    <time_frame>At baseline</time_frame>
    <description>This is based on questions derived from the Insomnia Severity Index Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in prevalence of sleep-related issues from baseline</measure>
    <time_frame>4-month follow-up</time_frame>
    <description>Insomnia Severity Index&#xD;
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at baseline.</measure>
    <time_frame>baseline</time_frame>
    <description>Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).&#xD;
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression&#xD;
Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.&#xD;
Higher score corresponding to more severe degree of anxiety.&#xD;
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of those with low mental wellbeing at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>This is based on questions derived from the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Scores of 7-17 represent probable depression or anxiety; Scores of 18-20 suggest possible depression or anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in proportion of those with low mental wellbeing from baseline to the end of study.</measure>
    <time_frame>4-month follow-up</time_frame>
    <description>Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Scores of 7-17 represent probable depression or anxiety; Scores of 18-20 suggest possible depression or anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of those who report concern related to work-place practices.</measure>
    <time_frame>At baseline</time_frame>
    <description>Self-reported measures through responses to direct questions relevant to work-related practices in the survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the prevalence from baseline of those who report concern related to work-place practices.</measure>
    <time_frame>6-week</time_frame>
    <description>Self-reported measures through responses to direct questions relevant to work-related practices in the survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the prevalence from baseline of those who report concern related to work-place practices.</measure>
    <time_frame>4 months</time_frame>
    <description>Self-reported measures through responses to direct questions relevant to work-related practices in the survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study</measure>
    <time_frame>4-month follow-up</time_frame>
    <description>Self-reported measures through responses to survey questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19</measure>
    <time_frame>Baseline</time_frame>
    <description>Self reported, based on the presence of symptoms with either self reported positive test, or self-isolation of 7 or more days.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">1721</enrollment>
  <condition>Mental Health</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internal Control</arm_group_label>
    <description>Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population Control</arm_group_label>
    <description>Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Follow-up cases</arm_group_label>
    <description>Doctors, nurses and other healthcare workers ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 consenting to receive follow-up surveys (n ~ 400)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Follow-up controls</arm_group_label>
    <description>Healthcare Administrative staff who are working in the hospital, not at risk of work-related exposure to patients potentially infected with COVID-19 (n~80)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index</intervention_name>
    <description>The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months</description>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Follow-up cases</arm_group_label>
    <arm_group_label>Follow-up controls</arm_group_label>
    <arm_group_label>Internal Control</arm_group_label>
    <arm_group_label>Population Control</arm_group_label>
    <other_name>Questionnaire</other_name>
    <other_name>Questionnaire to evaluate their current quantity and frequency of alcohol use, smoking habit and mental wellbeing score (abbreviated Warwick-Edinburgh).</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.</intervention_name>
    <description>Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires.</description>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Follow-up cases</arm_group_label>
    <arm_group_label>Follow-up controls</arm_group_label>
    <arm_group_label>Internal Control</arm_group_label>
    <arm_group_label>Population Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informed consent</intervention_name>
    <description>Participants will need to give their consent to participate to the survey after reading PIS</description>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Follow-up cases</arm_group_label>
    <arm_group_label>Follow-up controls</arm_group_label>
    <arm_group_label>Internal Control</arm_group_label>
    <arm_group_label>Population Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients&#xD;
        potentially infected with COVID-19 (n = minimum 800)&#xD;
&#xD;
        Healthcare /NHS Administrative staff who are working in the hospital, but not directly in&#xD;
        contact with patients potentially infected with COVID-19 (minimum n= 125) (internal&#xD;
        control)&#xD;
&#xD;
        Non-healthcare/non-NHS academic staff who are not working in the environment where patient&#xD;
        exposure is expected (minimum n=125) (population control)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged &gt;=18&#xD;
&#xD;
          2. Electronic consent&#xD;
&#xD;
          3. Either:&#xD;
&#xD;
        a - healthcare workers in contact with patients with confirmed or suspected COVID-19 b -&#xD;
        Healthcare staff not having direct patient contact c - Non-healthcare academic staff with&#xD;
        no direct patient contact&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age&lt;18&#xD;
&#xD;
          2. Individuals not belonging to the 3 cohorts of interest listed in the inclusion&#xD;
             criteria.&#xD;
&#xD;
          3. Those who are not able to understand written English will be excluded, indeed by the&#xD;
             design and methodology of the study, as the study invite and all other information&#xD;
             provided is in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ajay Gupta, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary University London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajay K Gupta</name>
      <address>
        <city>London</city>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>healthcare professionals</keyword>
  <keyword>Personal protective equipment</keyword>
  <keyword>covid-19</keyword>
  <keyword>SARS-CoV2</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/NCT04433260
org study id: 284686
nct id: NCT04433260
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current COVID-19 pandemic has affected more than 3 million people worldwide across more
      than 200 countries.

      In the United Kingdom alone, at the end of April, there were almost 160,000 confirmed cases
      with more than 20,000 deaths. This has undoubtedly had significant physical and economical
      impact on the public.

      Healthcare workers are at high risk of developing life-threatening infectious diseases with
      increased exposure to patients' blood and bodily fluids. As such, health care workers
      arguably experience heightened anxiety and are predisposed to greater negative psycho-social
      impact from the current COVID-19 pandemic.

      The aim of this study is to evaluate the physical and psychological impact of COVID-19 on
      healthcare workers. This will be performed in two phases.

      In phase 1, investigators will collect information to evaluate the current psychiatric
      symptom profile (in particular, screening for anxiety or depression related symptoms),
      alcohol use, sleep-related complaints and overall well-being among healthcare workers who
      participate in this survey (with a focus on junior doctors). In addition the association of
      these mental health and behavioural parameters with the prevalence of stressful occasions,
      such as long-hours, unpredictability of work / redeployment, availability of personal
      protection equipment and concerns regarding family/relationship and self will be assessed.

      In phase 2, investigators will then reassess for the development or progression of
      psychiatric symptoms, use of alcohol and other substances, behavioural or interpersonal
      relationship changes as well as physical well-being at 6 weeks and 4- months. Physical
      well-being is assessed through the presence of suspected or confirmed COVID-19 infection and
      absence from work. Specifically, investigators will study the impact of variable provision of
      personal protection equipment (supply and training), extended working hours, and concern for
      well-being of family members, on work morale and anxiety levels.

      Another aim is also study the longer term mental health consequences of the current pandemic
      on health care workers.
observational model: Cohort
time perspective: Cross-Sectional
measure: Presence of anxiety at baseline
time frame: baseline
description: Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety.
measure: Presence of depression at baseline
time frame: baseline
description: Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
measure: Proportion of those who report a combined outcome of presence of anxiety or depression at the baseline as determined by screening questionnaires used.
time frame: baseline
description: Anxiety will be investigated by 7-item Generalised Anxiety Disorder and depression will be investigated by 9-item patient health questionnaire. Presence of either one of those or both will be taken as the combined outcome.
For anxiety, 7-item Generalized anxiety disorder score (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety. For depression, the 9- item Patient Health Questionnaire (PHQ-9). Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
Higher score corresponding to more severe degree of anxiety.
measure: Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study
time frame: 4 months
description: Anxiety will be investigated by 7-item Generalised Anxiety Disorder and depression will be investigated by 9-item patient health questionnaire. Presence of either one of those or both will be taken as the combined outcome.
For anxiety, 7-item Generalized anxiety disorder score (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety. For depression, the 9- item Patient Health Questionnaire (PHQ-9). Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
measure: Change in the proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19 from baseline to the end of study
time frame: 4 months
description: Self reported, assessed based on the questions regarding the presence of symptoms with presence of either self reported positive test, or self-isolation of 7 or more days.
measure: Change in prevalence of anxiety from baseline
time frame: 4 months
description: Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety.
measure: Change in prevalence of depression from baseline
time frame: 4 months followup
description: Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
measure: Prevalence of sleep-related issues at baseline
time frame: At baseline
description: This is based on questions derived from the Insomnia Severity Index Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
measure: Change in prevalence of sleep-related issues from baseline
time frame: 4-month follow-up
description: Insomnia Severity Index
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
measure: Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at baseline.
time frame: baseline
description: Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety.
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
measure: Proportion of those with low mental wellbeing at baseline
time frame: baseline
description: This is based on questions derived from the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Scores of 7-17 represent probable depression or anxiety; Scores of 18-20 suggest possible depression or anxiety.
measure: Change in proportion of those with low mental wellbeing from baseline to the end of study.
time frame: 4-month follow-up
description: Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Scores of 7-17 represent probable depression or anxiety; Scores of 18-20 suggest possible depression or anxiety
measure: Prevalence of those who report concern related to work-place practices.
time frame: At baseline
description: Self-reported measures through responses to direct questions relevant to work-related practices in the survey
measure: Change in the prevalence from baseline of those who report concern related to work-place practices.
time frame: 6-week
description: Self-reported measures through responses to direct questions relevant to work-related practices in the survey
measure: Change in the prevalence from baseline of those who report concern related to work-place practices.
time frame: 4 months
description: Self-reported measures through responses to direct questions relevant to work-related practices in the survey
measure: Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study
time frame: 4-month follow-up
description: Self-reported measures through responses to survey questions
measure: Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19
time frame: Baseline
description: Self reported, based on the presence of symptoms with either self reported positive test, or self-isolation of 7 or more days.
arm group label: Cases
description: Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19
arm group label: Internal Control
description: Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19.
arm group label: Population Control
description: Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected.
arm group label: Follow-up cases
description: Doctors, nurses and other healthcare workers ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 consenting to receive follow-up surveys (n ~ 400)
arm group label: Follow-up controls
description: Healthcare Administrative staff who are working in the hospital, not at risk of work-related exposure to patients potentially infected with COVID-19 (n~80)
intervention type: Other
intervention name: Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index
description: The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months
arm group label: Cases
arm group label: Follow-up cases
arm group label: Follow-up controls
arm group label: Internal Control
arm group label: Population Control
other name: Questionnaire
other name: Questionnaire to evaluate their current quantity and frequency of alcohol use, smoking habit and mental wellbeing score (abbreviated Warwick-Edinburgh).
intervention type: Other
intervention name: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
description: Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires.
arm group label: Cases
arm group label: Follow-up cases
arm group label: Follow-up controls
arm group label: Internal Control
arm group label: Population Control
intervention type: Other
intervention name: Informed consent
description: Participants will need to give their consent to participate to the survey after reading PIS
arm group label: Cases
arm group label: Follow-up cases
arm group label: Follow-up controls
arm group label: Internal Control
arm group label: Population Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ajay Gupta, MD, PhD
role: Principal Investigator
affiliation: Queen Mary University London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided