NCT04506632

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

5.6 years

First QC Date

July 21, 2020

Last Update Submit

February 20, 2025

Conditions

Keywords

COVID-19CoronavirusNHS staffMental health

Outcome Measures

Primary Outcomes (5)

  • Changes in Depression

    We will assess depression with 9 items (PHQ-9);

    UP to 3 months after the pandemic ends in the UK

  • Changes in Anxiety

    measured by GAD-7

    UP to 3 months after the pandemic ends in the UK

  • Changes in feelings of paranoia

    measured by the short Green paranoia scale

    UP to 3 months after the pandemic ends in the UK

  • Traumatic Stress

    As measured by PHQ-15

    UP to 3 months after the pandemic ends in the UK

  • conspiracy mentality and social interactions

    as measured by the loneliness scale

    UP to 3 months after the pandemic ends in the UK

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will recruit NHS staff that are working during the COVID-19 pandemic.

You may qualify if:

  • 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

You may not qualify if:

  • Participants will not be excluded on any other basis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 1SJ, United Kingdom

Location

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsPsychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Study Officials

  • Sarah Danson, Professor

    Sheffield Teaching Hospitals NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

August 10, 2020

Study Start

June 2, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations