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Clinical Trials/NCT04433260
NCT04433260
Completed
Not Applicable

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

Queen Mary University of London1 site in 1 country1,721 target enrollmentJuly 25, 2020
ConditionsMental Health

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health
Sponsor
Queen Mary University of London
Enrollment
1721
Locations
1
Primary Endpoint
Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study
Status
Completed
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2020
End Date
June 16, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Electronic consent
  • 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

  • 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.

Outcomes

Primary Outcomes

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

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 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

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

Study Sites (1)

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