COVID19 and Physical and Emotional Wellbeing of HCP
- Conditions
- Mental Health
- Interventions
- 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 indexOther: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.Other: Informed consent
- Registration Number
- NCT04433260
- Lead Sponsor
- Queen Mary University of London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1721
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cases Informed consent Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 Internal Control 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 Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19. Internal Control Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19. Internal Control Informed consent Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19. Population Control 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 Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected. Population Control Informed consent Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected. Follow-up controls Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. 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) Follow-up controls Informed consent 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) Cases 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 Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 Follow-up cases Informed consent 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) Cases Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 Follow-up cases 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 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) Follow-up cases Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. 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) Follow-up controls 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 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) Population Control Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected.
- Primary Outcome Measures
Name Time Method Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study 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 depressionPresence of anxiety at baseline 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 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 depressionProportion of those who report a combined outcome of presence of anxiety or depression at the baseline as determined by screening questionnaires used. 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 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 Outcome Measures
Name Time Method Change in prevalence of sleep-related issues from baseline 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)Change in proportion of those with low mental wellbeing from baseline to the end of study. 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
Prevalence of sleep-related issues at baseline 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)
Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study 4-month follow-up Self-reported measures through responses to survey questions
Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at baseline. 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)Proportion of those with low mental wellbeing at baseline 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.
Prevalence of those who report concern related to work-place practices. At baseline Self-reported measures through responses to direct questions relevant to work-related practices in the survey
Change in prevalence of depression from baseline 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 depressionChange in the prevalence from baseline of those who report concern related to work-place practices. 4 months Self-reported measures through responses to direct questions relevant to work-related practices in the survey
Change in prevalence of anxiety from baseline 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.Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19 Baseline Self reported, based on the presence of symptoms with either self reported positive test, or self-isolation of 7 or more days.
Trial Locations
- Locations (1)
Ajay K Gupta
🇬🇧London, United Kingdom