Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1721 participants
OBSERVATIONAL
2020-07-25
2024-06-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Cases
Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19
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
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
Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
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.
Informed consent
Participants will need to give their consent to participate to the survey after reading PIS
Internal Control
Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19.
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
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
Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
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.
Informed consent
Participants will need to give their consent to participate to the survey after reading PIS
Population Control
Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected.
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
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
Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
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.
Informed consent
Participants will need to give their consent to participate to the survey after reading PIS
Follow-up cases
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)
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
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
Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
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.
Informed consent
Participants will need to give their consent to participate to the survey after reading PIS
Follow-up controls
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)
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
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
Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
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.
Informed consent
Participants will need to give their consent to participate to the survey after reading PIS
Interventions
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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
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
Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
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.
Informed consent
Participants will need to give their consent to participate to the survey after reading PIS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Electronic consent
3. Either:
a - healthcare workers in contact with patients with confirmed or suspected COVID-19 b - Healthcare staff not having direct patient contact c - Non-healthcare academic staff with no direct patient contact
3. Those who are not able to understand written English will be excluded, indeed by the design and methodology of the study, as the study invite and all other information provided is in English.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Ajay Gupta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University London
Locations
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Ajay K Gupta
London, , United Kingdom
Countries
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References
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Collett G, Kotecha A, Gupta A. Burnout and Depression Among UK-Based Healthcare Professionals: Insights From a 3-Year Prospective Cohort Study Regarding Potential Mitigation Strategies. J Occup Environ Med. 2025 Jul 1;67(7):477-482. doi: 10.1097/JOM.0000000000003364. Epub 2025 Feb 21.
Siddiqui I, Gupta J, Collett G, McIntosh I, Komodromos C, Godec T, Ng S, Maniero C, Antoniou S, Khan R, Kapil V, Khanji MY, Gupta AK; CoPE-HCP clinical investigators. Perceived workplace support and mental health, well-being and burnout among health care professionals during the COVID-19 pandemic: a cohort analysis. CMAJ Open. 2023 Feb 28;11(1):E191-E200. doi: 10.9778/cmajo.20220191. Print 2023 Jan-Feb.
Khanji MY, Collett G, Godec T, Maniero C, Ng SM, Siddiqui I, Gupta J, Kapil V, Gupta A. Improved lifestyle is associated with improved depression, anxiety and well-being over time in UK healthcare professionals during the COVID-19 pandemic: insights from the CoPE-HCP cohort study. Gen Psychiatr. 2023 Jan 20;36(1):e100908. doi: 10.1136/gpsych-2022-100908. eCollection 2023.
Khanji MY, Maniero C, Ng S, Siddiqui I, Gupta J, Crosby L, Antoniou S, Khan R, Kapil V, Gupta A. Early and Mid-Term Implications of the COVID-19 Pandemic on the Physical, Behavioral and Mental Health of Healthcare Professionals: The CoPE-HCP Study Protocol. Front Psychol. 2021 Feb 2;12:616280. doi: 10.3389/fpsyg.2021.616280. eCollection 2021.
Other Identifiers
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284686
Identifier Type: -
Identifier Source: org_study_id
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