COVID19 and Physical and Emotional Wellbeing of HCP

An observational study of Mental Health, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Mental Health
What is being tested?: 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, Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. and Informed consent
How many people: 1,721 participants
Where: 1 siteUnited Kingdom
Study dates: 25 Jul 2020to 16 Jun 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 (n = minimum 800) Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19 (minimum n= 125) (internal control) Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected (minimum n=125) (population control)

Who may be able to join

Aged >=18
Electronic consent
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

Who cannot join

Age<18
Individuals not belonging to the 3 cohorts of interest listed in the inclusion criteria.
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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Ajay K Gupta
London, EC1M 6BQ

Other trials in United Kingdom

About this study

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

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.

Conditions: Mental Health
Being tested: 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, Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too., Informed consent
Keywords: healthcare professionals, Personal protective equipment, covid-19, SARS-CoV2
Medical subject headings: Psychological Well-Being, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity indexOther
Also called Questionnaire, Questionnaire to evaluate their current quantity and frequency of alcohol use, smoking habit and mental wellbeing score (abbreviated Warwick-Edinburgh).
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.Other
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 consentOther
Participants will need to give their consent to participate to the survey after reading PIS

Study groups in NCT04433260
Study group	Role	What they receive
Cases		Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 Receives: Other: 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; Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.; Other: Informed consent
Internal Control		Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19. Receives: Other: 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; Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.; Other: Informed consent
Population Control		Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected. Receives: Other: 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; Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.; Other: Informed consent
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) Receives: Other: 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; Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.; Other: Informed consent
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) Receives: Other: 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; Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.; Other: Informed consent

What is being measured

The primary outcome is the main question the study is designed to answer.

Presence of anxiety at baseline
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.
Measured: baseline
Presence of depression at baseline
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
Measured: baseline
Proportion of those who report a combined outcome of presence of anxiety or depression at the baseline as determined by screening questionnaires used.
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.
Measured: baseline
Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study
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
Measured: 4 months
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
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.
Measured: 4 months

Secondary outcomes (12)

Change in prevalence of anxiety from baseline
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.
Measured: 4 months
Change in prevalence of depression from baseline
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
Measured: 4 months followup
Prevalence of sleep-related issues at baseline
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)
Measured: At baseline
Change in prevalence of sleep-related issues from baseline
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)
Measured: 4-month follow-up
Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at baseline.
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)
Measured: baseline
Proportion of those with low mental wellbeing at baseline
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.
Measured: baseline
Change in proportion of those with low mental wellbeing from baseline to the end of study.
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
Measured: 4-month follow-up
Prevalence of those who report concern related to work-place practices.
Self-reported measures through responses to direct questions relevant to work-related practices in the survey
Measured: At baseline
Change in the prevalence from baseline of those who report concern related to work-place practices.
Self-reported measures through responses to direct questions relevant to work-related practices in the survey
Measured: 6-week
Change in the prevalence from baseline of those who report concern related to work-place practices.
Self-reported measures through responses to direct questions relevant to work-related practices in the survey
Measured: 4 months
Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study
Self-reported measures through responses to survey questions
Measured: 4-month follow-up
Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19
Self reported, based on the presence of symptoms with either self reported positive test, or self-isolation of 7 or more days.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 202016 Jun 2024

First posted16 Jun 2020
Study start25 Jul 2020
Primary completion31 Mar 2021
Study completion16 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Mental HealthStudies of the same condition, open and under way.
More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 1,721 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04433260
Sponsor's protocol ID: 284686
Acronym: CoPE-HCP
Status last verified: Feb 2025
First submitted: 9 Jun 2020
Last updated: 13 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 40063847
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.
PubMed 36854456
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.
PubMed 36751400
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.
PubMed 33603701

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04433260
Acronym / sponsor ID: CoPE-HCP / 284686
Conditions: Mental Health
Keywords: healthcare professionals, Personal protective equipment, covid-19, SARS-CoV2
Study type: Observational
Recruitment status: Completed
Enrolment: 1,721 participants (actual)
Lead sponsor: Queen Mary University of LondonUniversity, hospital or other
Study start: 25 Jul 2020 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 16 Jun 2024 (actual)
First posted: 16 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The current COVID-19 pandemic has affected more than 3 million people worldwide across more than 200 countries.

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.

Another aim is also study the longer term mental health consequences of the current pandemic on health care workers.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 5

Arm	Type	Receives
Cases	–	Other: 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, Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too., Other: Informed consentDoctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19
Internal Control	–	Other: 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, Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too., Other: Informed consentHealthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19.
Population Control	–	Other: 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, Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too., Other: Informed consentNon-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected.
Follow-up cases	–	Other: 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, Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too., Other: Informed consentDoctors, 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)
Follow-up controls	–	Other: 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, Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too., Other: Informed consentHealthcare Administrative staff who are working in the hospital, not at risk of work-related exposure to patients potentially infected with COVID-19 (n~80)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 (n = minimum 800) Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19 (minimum n= 125) (internal control) Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected (minimum n=125) (population control)

Key inclusion criteria (4 listed)

Aged >=18
Electronic consent
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

Key exclusion criteria (3 listed)

Age<18
Individuals not belonging to the 3 cohorts of interest listed in the inclusion criteria.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity indexAlso: Questionnaire, Questionnaire to evaluate their current quantity and frequency of alcohol use, smoking habit and mental wellbeing score (abbreviated Warwick-Edinburgh).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	Other	Cases, Follow-up cases, Follow-up controls, Internal Control, Population Control
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.	Other	Cases, Follow-up cases, Follow-up controls, Internal Control, Population Control
Informed consentParticipants will need to give their consent to participate to the survey after reading PIS	Other	Cases, Follow-up cases, Follow-up controls, Internal Control, Population Control

Primary outcome

Presence of anxiety at baseline
Time frame: baseline
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.
Presence of depression at baseline
Time frame: baseline
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
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
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.
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
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
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
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.

12 secondary outcomes

Change in prevalence of anxiety from baseline
Time frame: 4 months
Change in prevalence of depression from baseline
Time frame: 4 months followup
Prevalence of sleep-related issues at baseline
Time frame: At baseline
Change in prevalence of sleep-related issues from baseline
Time frame: 4-month follow-up
Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at baseline.
Time frame: baseline
Proportion of those with low mental wellbeing at baseline
Time frame: baseline
Change in proportion of those with low mental wellbeing from baseline to the end of study.
Time frame: 4-month follow-up
Prevalence of those who report concern related to work-place practices.
Time frame: At baseline
Change in the prevalence from baseline of those who report concern related to work-place practices.
Time frame: 6-week
Change in the prevalence from baseline of those who report concern related to work-place practices.
Time frame: 4 months
Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study
Time frame: 4-month follow-up
Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
Derived from this study: PubMed 40063847Collett 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.
Derived from this study: PubMed 36854456Siddiqui 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.
Derived from this study: PubMed 36751400Khanji 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.
Derived from this study: PubMed 33603701Khanji 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ajay Gupta, MD, PhD principal investigator

Queen Mary University London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of anxiety at baseline (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433260, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.