COVID19 and Physical and Emotional Wellbeing of HCP

Mental Health Clinical Trial

— CoPE-HCP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433260
• Other study ID #: 284686
• Status: Completed
• Start date: July 25, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2022
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1721
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged >=18

2. Electronic consent

3. 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:

1. Age<18

2. Individuals not belonging to the 3 cohorts of interest listed in the inclusion criteria.

3. 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.

Related Conditions & MeSH terms

• COVID-19
• Mental Health

Intervention

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 index
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
• Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.
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
Participants will need to give their consent to participate to the survey after reading PIS

Locations

Country	Name	City	State
United Kingdom	Ajay K Gupta	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of anxiety at 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.	baseline
Primary	Presence of depression at 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	baseline
Primary	Proportion of those who report a combined outcome of presence of anxiety or depression at the baseline as determined by screening questionnaires used.	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.	baseline
Primary	Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study	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	4 months
Primary	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	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.	4 months
Secondary	Change in prevalence of anxiety from 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.	4 months
Secondary	Change in prevalence of depression from 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	4 months followup
Secondary	Prevalence of sleep-related issues 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)	At baseline
Secondary	Change in prevalence of sleep-related issues from baseline	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-month follow-up
Secondary	Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at 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)	baseline
Secondary	Proportion of those with low mental wellbeing at 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.	baseline
Secondary	Change in proportion of those with low mental wellbeing from baseline to the end of study.	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	4-month follow-up
Secondary	Prevalence of those who report concern related to work-place practices.	Self-reported measures through responses to direct questions relevant to work-related practices in the survey	At baseline
Secondary	Change in the prevalence from baseline of those who report concern related to work-place practices.	Self-reported measures through responses to direct questions relevant to work-related practices in the survey	6-week
Secondary	Change in the prevalence from baseline of those who report concern related to work-place practices.	Self-reported measures through responses to direct questions relevant to work-related practices in the survey	4 months
Secondary	Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study	Self-reported measures through responses to survey questions	4-month follow-up
Secondary	Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19	Self reported, based on the presence of symptoms with either self reported positive test, or self-isolation of 7 or more days.	Baseline