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Completed

NCT Number: NCT04433260

COVID19 and Physical and Emotional Wellbeing of HCP

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.

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Key information

Conditions

Mental Health Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Personal Satisfaction Pneumonia Pneumonia, Viral Psychological Well-Being RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajay K Gupta

London, EC1M 6BQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

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 names: Questionnaire, Questionnaire to evaluate their current quantity and frequency of alcohol use, smoking habit and mental wellbeing score (abbreviated Warwick-Edinburgh).

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 consent

Other

Participants will need to give their consent to participate to the survey after reading PIS

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.

Secondary outcomes

  1. Change in prevalence of anxiety from baseline

    Time frame: 4 months

    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.

  2. Change in prevalence of depression from baseline

    Time frame: 4 months followup

    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

  3. Prevalence of sleep-related issues at baseline

    Time frame: 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)

  4. Change in prevalence of sleep-related issues from baseline

    Time frame: 4-month follow-up

    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)

  5. Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues 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

    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)

  6. Proportion of those with low mental wellbeing at baseline

    Time frame: 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.

  7. Change in proportion of those with low mental wellbeing from baseline to the end of study.

    Time frame: 4-month follow-up

    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

  8. Prevalence of those who report concern related to work-place practices.

    Time frame: At baseline

    Self-reported measures through responses to direct questions relevant to work-related practices in the survey

  9. Change in the prevalence from baseline of those who report concern related to work-place practices.

    Time frame: 6-week

    Self-reported measures through responses to direct questions relevant to work-related practices in the survey

  10. Change in the prevalence from baseline of those who report concern related to work-place practices.

    Time frame: 4 months

    Self-reported measures through responses to direct questions relevant to work-related practices in the survey

  11. Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study

    Time frame: 4-month follow-up

    Self-reported measures through responses to survey questions

  12. Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19

    Time frame: Baseline

    Self reported, based on the presence of symptoms with either self reported positive test, or self-isolation of 7 or more days.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study 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

Acronym: CoPE-HCP

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Jun 16, 2020
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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