COVID-19COST-NHSNCT04506632
Burden for STaff Working in the NHS
An observational study of COVID-19 and Mental Health Burden, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Mental Health Burden
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will recruit NHS staff that are working during the COVID-19 pandemic.
Who may be able to join
- Participants aged 16 years or over
- Participants must be working in the NHS
- NHS staff that are shielding will be eligible to participate
- NHS staff that are self-isolating will be eligible to participate
- Able and willing to provide informed consent
- Able to read and understand English
Who cannot join
- Participants will not be excluded on any other basis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 1SJ
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- COVID-19, Mental Health Burden
- Keywords
- COVID-19, Coronavirus, NHS staff, Mental health
- Medical subject headings
- COVID-19, Coronavirus Infections, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depression
We will assess depression with 9 items (PHQ-9);
Measured: UP to 3 months after the pandemic ends in the UK
Changes in Anxiety
measured by GAD-7
Measured: UP to 3 months after the pandemic ends in the UK
Changes in feelings of paranoia
measured by the short Green paranoia scale
Measured: UP to 3 months after the pandemic ends in the UK
Traumatic Stress
As measured by PHQ-15
Measured: UP to 3 months after the pandemic ends in the UK
conspiracy mentality and social interactions
as measured by the loneliness scale
Measured: UP to 3 months after the pandemic ends in the UK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start2 Jun 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Sarah Danson, Professor, Study director, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506632
- Sponsor's protocol ID
- STH21373
- Acronym
- COST-NHS
- Status last verified
- Feb 2025
- First submitted
- 21 Jul 2020
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04506632
- Acronym / sponsor ID
- COST-NHS / STH21373
- Conditions
- COVID-19, Mental Health Burden
- Keywords
- COVID-19, Coronavirus, NHS staff, Mental health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Aug 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 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.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will recruit NHS staff that are working during the COVID-19 pandemic.
Key inclusion criteria (6 listed)
- Participants aged 16 years or over
- Participants must be working in the NHS
- NHS staff that are shielding will be eligible to participate
- NHS staff that are self-isolating will be eligible to participate
- Able and willing to provide informed consent
Key exclusion criteria (1 listed)
- Participants will not be excluded on any other basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Depression
Time frame: UP to 3 months after the pandemic ends in the UK
We will assess depression with 9 items (PHQ-9);
Changes in Anxiety
Time frame: UP to 3 months after the pandemic ends in the UK
measured by GAD-7
Changes in feelings of paranoia
Time frame: UP to 3 months after the pandemic ends in the UK
measured by the short Green paranoia scale
Traumatic Stress
Time frame: UP to 3 months after the pandemic ends in the UK
As measured by PHQ-15
conspiracy mentality and social interactions
Time frame: UP to 3 months after the pandemic ends in the UK
as measured by the loneliness scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Sarah Danson, Professor study director
Sheffield Teaching Hospitals NHS Foundation Trust
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 COVID-19 and Mental Health Burden, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in Depression (time frame: UP to 3 months after the pandemic ends in the UK). 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?
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 24 Feb 2025.