Psychological impact of COVID-19 Pandemic: Protocol and Results of first three weeks from an international cross-section survey - focus on health professionals


                  Background
                  The psychological impact of COVID-19, resultant measures and future consequences to life will be unveiled in time.
               
                  Aim
                  To investigate the psychological impact of COVID-19, resultant restrictions, impact on behaviours and mental wellbeing globally. This early analysis, explores positive and adverse factors and behaviours with focus on healthcare professionals.
               
                  Methods
                  This is a cross-sectional survey, using a questionnaire based on published approaches to understand the psychological impact of COVID-19. The survey will be repeated at 6 months because of rapidly changing situation.
               
                  Results
                  We have presented results from first 3 weeks of the survey. Conclusions may change as more individuals take part over time.
                  7,917 participants completed the survey in the first 3 weeks; 7,271 are from the United Kingdom. 49.7% of the participants are healthcare professionals. There is high representation of female participants. Participants reporting suicidal thoughts is 32%. Healthcare professionals have reported mild depression and anxiety in higher proportions. Increasing age and female gender report higher compliance with government advice on COVID 19 whereas higher education, homeowners, key worker status, high alcohol, drug use and participants with pre-existing suicidal thoughts reported low compliance with government advice. Participants who reported suicidal thoughts pre-COVID are less likely to communicate with friends and family, or engage in coping strategies.
               
                  Conclusions
                  Evidence has shown an adverse psychological impact of previous pandemics on the population, especially wellbeing of healthcare professionals. Research should focus on identifying the need, preparing services and determining the factors that enhance and build resilience.
               
                  Funding
                  This survey is linked to a MRC global health research program of the Portsmouth-Brawijaya Centre for Global Health, Population, and Policy, (MR/N006267/1), University of Portsmouth.
               

7 depression and stress that resulted in meeting the diagnosis of post-traumatic stress disorder (Lee et al., 2018;Tam et al., 2004). Other studies have shown that the potential to transmit the disease to families and friends have been a fear weighing in healthcare professionals minds (Rubin et al. 2020;Wingfield et al. 2020;Brooks et al. 2020).
Despite the rapidly building evidence on the impact of COVID 19, there are significant gaps due to the unprecedented nature of the pandemic and the resultant changes across the globe. Each study makes a unique contribution and adds a different perspective, thereby improving generalisability and our understanding of the landscape.
Given the unique situation we face, we sought to explore, via an international study, the psychological impact of COVID-19, the resultant restrictions and impact on emotions, behaviours and changes in mental health and wellbeing.

Main purpose of this study
To investigate the psychological impact of COVID-19, the resultant restrictions and impact on behaviours and changes in mental wellbeing across the global population.
We also aim to explore what pre-COVID-19 factors and behaviours may support people's wellbeing and what might have a negative impact.
The study is designed to explore the psychological impact of COVID-19 on the following groups though they are not mutually exclusive: For interim analysis in first three weeks of the study we wanted to investigate: 1. Are families with experience of COVID-19, healthcare workers, and people with pre-existing mental health conditions or other co morbid conditions or vulnerabilities more likely to experience mental health consequences compared to others? 2. Are there differences in psychological impact of COVID 19 for different demographics Null hypothesis: There will be no difference in the psychological impact of COVID-19 between the different groups or by demographics.

Methodology
This is a repeated, cross-sectional study. The survey will be repeated at 6 months because of rapidly changing situation and potential of second wave of the pandemic, predicted in the winter. We devised an online questionnaire, based on published approaches, to understand the psychological impact of COVID-19 and the resultant restrictions. Five standardised measures have been included to explore levels of depression (Patient Health Questionnaire-9; Kroenke and Spitzer, 2002), anxiety (GAD-7;Generalised Anxiety Disorder Assessment;Spitzer et al., 2006) impact (The Impact of Event Scale-Revised; IES -R; Weiss and Marmar, 1997), loneliness (a brief loneliness scale, Hughes, et al;2004) and social support (The Multidimensional Scale of Perceived Social support; MSPSS, Zimet et al, 1988) The questionnaire has several versions. The first version has been implemented in the UK, and the other versions have been adapted based on cultures and landscapes of different countries. The adaptations are culturally informed and translated into local languages to make them relevant and sensitive to local populations. The questions have been investigated for face and content validity with a limited relevant sample before using them in the survey.
We have reviewed other questionnaires currently being implemented and found that each is unique and different in what it is trying to measure. For an unknown entity like COVID-19, over-inclusiveness and repetition improves validity.
In the UK, the questionnaire was implemented on 1 st May 2020 with Southern Health NHS Foundation Trust as the sponsor. Since then, 50 National Health Service (NHS)

Trusts, Universities and The Centre for Applied Research and Evaluation
International Foundation (CAREIF) have collaborated and are advertising the survey to their staff, patients and public. Organisations joined slowly as in the first week there were 18 organisations, 37 in the second week and 42 in the third week of this analysis paper. Of the 42 NHS organisations, 26 were mental health and community trusts and 18 were acute NHS organisations. Further organisations joined and recruitment continues until 31 st July 2020 for the first wave. The second wave will commence from 1 st October to 31 st December 2020.

Study Sample
This is a participatory study, as the sampling is based on self-selection by the participants if they meet the criteria.

Inclusion criteria
The inclusion criteria for this survey are broad to capture the views of any individual above 16 years of age who would like to respond to the online questionnaire. We aim to include members of the public, keyworkers, including HCP, individuals who have suffered COVID-19, and those with vulnerabilities like Diabetes, Hypertension, pre-existing mental health conditions.

Exclusion Criteria
No specific exclusion criteria apart from those unwilling or who lack the capacity to participate.

Recruitment
Participants are invited to participate in the study via multiple media sources, including social media, newsletters, communication platforms within participating organisations and countries.

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Informed consent is implied. Participants are allowed as much time as they wish to consider the information and to decide whether to participate in the study. The survey includes a participant information sheet detailing the relevant information regarding the study. Participants have the right to withdraw from participating in the study before submitting it. The surveys are anonymous, participants can leave an email address if they would like to be contacted about the second wave of the study and this is stored separately to their survey data.

Questionnaire Design
The questionnaire is designed to be completed using Qualtrics XM, a cloud-based online platform. The survey consists of 35 questions divided into 5 parts. It takes 12-16 minutes to complete. The different sections of the questionnaire are: PART A: Demographics -this section ascertains participant characteristics such as age, gender, ethnicity, nationality, and country in which they reside, religion, level of education, employment status and sector and accommodation. PART B: About participants' health including core questions about health and wellbeing.
PART C: Participants' experience and knowledge of COVID-19 including access to COVID-19 information guidance and updates, compliance to advice, information guidance and updates, changes in behaviours, including self-isolation.
PART D: Psychological impact including validated measures adapted for this survey.

Study Analysis Strategy
We aim to provide timely information to inform the public, organisations, and policymakers regarding the psychological impact of COVID-19. Therefore the following analytic strategy is used for this paper that focusses on rapid response, initially with three weeks data. As a high proportion of respondents in our dataset is HCP, we have focussed our interim analysis on this group.
Descriptive statistics for categorical data are presented as frequencies and proportions for the whole sample and relevant subgroups. The association between categorical variables is considered through t-test. Statistical significance is indicated by p-values.
Outcomes are measured as categorical variables. Except for the outcome 'change in suicidal thoughts due to corona virus', that has two categories (yes/no), all other outcomes have more than two categories, and those multiple categories are ordinal (e.g., GAD-7: 0-4 score implies minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety) variables.. For all outcomes, we have conducted ordered logit regressions with adjustment for appropriate (observed) confounders. 13 We have reported changes in log-odds ratios as coefficients, and marginal effects of healthcare professional dummy, and those by their gender. The statistical software packages SPSS and R are employed for data and regression analyses as appropriate.
Missing data figures indicating a selection bias, are high for few questions but generally there has been good response to most questions. Therefore we did not conduct tests like instrumental variable regression.

Data Management
We aim to present the results of this study in aggregate form, with no individuals being identified. All data is being collected in a secure password protected Qualtrics XM online cloud based platform. Access to systems is restricted to specific individuals whose access is monitored and audited for compliance.
Data exported from the survey platform is anonymous, stored and managed in password protected files on encrypted computers and servers. Access to electronic data is limited only to members of the research team. Study documentation will be archived in accordance with guidelines for Good Clinical Practice and in NHS approved, secure and adequate archiving facility. Research personnel will keep information relevant to the study for up to 15 years, and then will be destroyed.

Ethics
The study received ethics and HRA approval (IRAS project ID: 282858; REC reference: 20/HRA/1934) on 27 April 2020. approximately 6% receive mental health services and approx. 43% are from the general population as per the categories of participants we sought. As this is initial data the numbers in different categories are variable. Table 1 shows summary statistics of demographics by non-HCP and HCP that are the large groups.

Summary
Means in age categories imply that participating HCP are proportionately higher in middle age groups than non-HCP. Professionals from White ethnic background are 3.1% lower in the sample (with statistical significance) in the HCP group than the non-HCP group; indicating higher proportions of Asian and Black ethnic minority professionals in the health sector than within the participating population. Muslims and Hindus present significantly higher in HCP, but individuals with no stated religion mostly work in the non-healthcare sector. The data shows a higher proportion of females in the healthcare profession compared to their male counterparts. Higher education is reported in higher proportions in the healthcare professions, as the data suggests 22.7% more HCP have attended University education compared to nonhealthcare workers.
In the sample, around 5% more HCP live in their own houses compared to non-HCP.
Halls of residence, parent's home and other accommodation show statistically significant negative differences in means, implying lower proportions of the participating HCP live in this type of accommodation. The response rate on key worker status is low due to missing values. Among 4,302 respondents who identified as keyworkers, most work in the health and social care sector, with only 369 in the social care sector. Among non-HCP, 33% work in the health and social care sector, implying that many respondents work in this sector, but they do not consider themselves as HCP.
Part B: About your health Table 2 here   Table 2 shows the summary statistics of pre-COVID health condition and wellbeing.
Most of the participants (4,661) have not reported pre-existing listed health problems. In theory, a person might have multiple health conditions, but in this data, we did not see that. The largest pre-existing condition reported is depression. Social phobia, Post-Traumatic Stress Disorder, Alcohol/Drug problems, Bi-polar disorder, and Personality disorder show to be statistically and significantly lower in HCP than others, except for Anorexia. Participants who reported drinking alcohol 4 times or more a week or never are significantly lower among HCP. Drug users present as lower in the HCP group, although overall numbers are low. 2,309 (32%) participants reported experiencing suicidal thoughts, with no statistical differences between the groups. Non-HCP seek help from counsellors/psychologist/psychotherapist and Community Mental Health Teams in higher proportions compared to HCP according to the data.
Part C: COVID-19 Information and advice The most common sources of information about coronavirus reported are TV news programmes (18.30%), social media (10.37%), Government briefings (13.70%), News apps (9.75%), the NHS website (10.40%), Gov.uk website (9.67%), and employer (15.07%). Participants are most likely to find that social media stories make them feel worried and fearful but they are unlikely to believe the information with only about 10% noting they believe social media stories. There are multiple sources of data that are not mutually exclusive for the participants. Table 3 shows the summary statistics of attitudes and health outcomes due to coronavirus analysed by HCP. This table indicates that HCP are more compliant with government advice (several times and most of the time) and in higher proportions than others, with rare engagement in risky activities (e.g., going shops, party, and social gathering frequently) being significantly lower than the counterparts.  Table 3 imply that HCP have mild depression and anxiety in higher proportions than others.
Alcohol intake increased in significantly higher proportions among HCP than others, but drug use remains the same in both groups. The increase in mental health support is higher among HCP than others. Non-HCP have more worries than HCP, as mean differences are significantly higher in the categories a little bit and moderately.
Part E: Coping Strategies Table 4 here Table 4 shows the summary statistics of coping mechanisms by non-HCP and HCP.
The analysis shows that daily communication with friends and family is significantly higher among HCP than others. In spite of this, they report as feeling more isolated from friends and family than non-HCP.
HCP show higher coping activities compared to others. The impact on coping activity time is the same between the two groups. However, HCP report significantly higher confidence in coping than others.

Ordered Logit Regressions
Tables 5, 6, 7 and 8 show results of ordered logit regressions of all outcomes listed in Tables 3 and 4. Coefficients in Tables 5, 6, 7 and 8 are changes in log-odds ratios due to changes in covariates (demographics and pre-existing health conditions and wellbeing). The signs of coefficients imply in which direction covariates affect outcomes.
Tables 5, 6, 7 and 8 indicate that HCP have lower mental health scale scores than others. For example, being a HCP decreases log-odds ratio of severe anxiety (GAD-7) by 0.180, which is statistically significant at 5%. Below is a summary of the effects of all other demographics and pre-existing health conditions and wellbeing on those outcomes, on which statistically significant effects are seen: 1.
Age: As age increases, following government advice, coping activities, amount of coping activity time, and confidence in coping rise, but risky activities, communications with family and scores on PHQ-9 and GAD-7 fall.

2.
Ethnicity: Black and Asian minority ethnicities show lower mental health support than white and others. Black minority participants show lower drug use than others. Asian minority participants show much higher suicidal thoughts than others.
Relationships with friends and family are lower among White but higher among Asians.

3.
Religion: Jewish participants report less risky activities than others. Christian participants report higher GAD-7 scores than others. Muslim and Hindu participants report higher drug use than others. Jewish participants receive higher mental health support than others. Christian participants report more worries about coronavirus than other religious groups. Sikh, then Muslims and then Christians maintained higher relations with friends and family than others, and they also had higher coping activities than others.

4.
Gender: Male participants follow government advice less than female participants, and they have lower PHQ-9, GAD-7, IES-R scores, alcohol consumption, mental health difficulties, worries about the virus, communications with friends and family, and activity time compared female counterparts. They have higher confidence in coping than females.

5.
Education: According to the data, as education increases, conformation to government advice decreases; PHQ-9, alcohol consumption, relationship with friends and family increases; GAD-7 scores, worries about the virus, coping activities, activity time, and confidence in coping decreases.

6.
Accommodation: Those who live in own home report higher compliance with government advice, coping activities, and confidence on coping and lower scores on PHQ-9, GAD-7, IES-R, and impact on mental health.
7. Key worker: Likelihood of following government advice decreases in key workers working in health and social care, key public services, and food services. Food workers report high likelihood of doing risky activities, and transport workers, report the opposite. Food workers also report higher scores of PHQ-9 and GAD-7 compared to others. The log likelihood of drinking alcohol increases among transport and utility workers. While the drug use of most of the key workers increases, the opposite is reported by utility workers. Most of the key workers have higher likelihood of suicidal thoughts and worries about coronavirus compared to others. Health and social care workers have less communication with friends and family, and therefore, their coping activities and time of those activities have been lower than others.
Education workers have been able to manage higher relations with friends and family, and higher coping activities than others.
8. Pre-existing health conditions: Respondents with pre-existing anxiety and panic attacks are more likely to have higher scores on PHQ-9, GAD-7, IES-R scores than others, and their coping activities reduce and confidence on coping reduces too.
Individuals with anorexia and psychosis have lower likelihood of doing risky activities than others, but patients with psychosis have lower likelihood of having higher 20 scores of GAD-7 than others. Individuals with Bulimia, Bipolar disorder, and personality disorder report less likelihood of following government advice than others. Most of the individuals with pre-existing health conditions have higher scores of PHQ-9, GAD-7 and IES-R than others. Alcohol drinking increases among individuals with social phobia, attention deficit, and personality disorder. Drug use increases among respondents with Bipolar disorder and personality disorder.
Suicidal thoughts increase amongst almost all individuals with pre-existing health conditions. However, coping activities and confidence on coping reduce among most of the individuals with pre-existing health conditions. 9. Alcohol: Higher alcohol intake before COVID-19 leads to lower compliance with government advice but higher scores of PHQ-9, GAD-7 and IES-R, and also higher coping activities, communications with friends and family and confidence on coping.
10. Drug use: Participants who report drug use have less likelihood of following government advice, communicating with friends and family, and coping activities, but higher likelihood of doing risky activities, with higher scores on PHQ-9 and GAD-7 compared to others.
11. Suicidal thoughts: Individuals with pre-COVID-19 suicidal thoughts show lower likelihood of following government advice, communications with friends and family, coping activities, confidence on coping, but higher likelihood of doing risky activities, with higher scores on PHQ-9, GAD-7, and IES-R.
12. Mental health support: Mental health support from GP, and counsellor largely increases with higher scores of PHQ-9, GAD-7, IES-R, but shows reduced confidence in coping.

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Marginal Effects Table 9 shows marginal effects of all HCP, male HCP, and female HCP on outcomes. They are estimated from ordered logit models including all other covariates as shown in Tables 5, 6 report periodic results as the temporal changes will be relevant considering changing government guidance that will impact on the population's responses and emotions.
In the final report, using data from all participant countries, we aim to compare the cultural and political landscapes impacting on psychological response to the pandemic, thereby informing future global crisis.
The survey was launched in complete lockdown, but within 3 weeks of these results, there has been minor movement. Our survey in the first three weeks has recruited mainly HCP. This is possible because the survey is supported by NHS organisations.
There is a predominance of females, which is not in accordance with the general population, but considering the majority of HCP; this may be understood as there is reported majority of females in the healthcare workforce (NHS Digital, 2019). The ethnicity of respondents is not representative of the general population, but this may be a reflection of the areas where the survey was implemented in the first three weeks. The data reports that age and gender have a correlation with following government advice. This finding resonates the results from Fancourt and colleagues' study (Fancourt et al., 2020).
Vindegaard and Eriksen Benros, (2020) conducted a systematic review of studies measuring psychiatric symptoms or morbidities associated with COVID-19 among infected patients and among non-infected groups, the latter divided into psychiatric patients, HCP and non-HCP. They included 43 studies, of which two papers evaluated patients with confirmed COVID-19 infection, and 41 the indirect effect of the pandemic (2 on patients with pre-existing psychiatric disorders, 20 on medical healthcare workers and 19 on the general public). 18 of the studies were casecontrol studies or compared to norms, while 25 of the studies had no control groups.

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They concluded that among healthcare workers depression/depressive symptoms, anxiety, psychological distress and poor sleep quality were increased. Regarding the public, one paper revealed lower psychological well-being compared to before COVID-19, while a longitudinal study found no difference in anxiety, depression or stress symptoms early in the pandemic compared to after four weeks. A variety of factors were associated with a higher risk of psychiatric symptoms and/or low psychological well-being of the public including female gender, front-line HCP, and poor self-rated health.
In our survey three week analysis, 32% participants reported experiencing suicidal As we continue recruitment to the study, the temporal relations in findings will be interesting as they will correspond with changes in the general landscape. We also aim to get better insights as international sites start recruiting. It is also worth noting that that at the time of writing there are two events that could and will likely influence the Asian and Black ethnic group psychologythe publication of the Public Health England report (Public Health England, 2020) which states that Black and Asian 24 Minority Ethnic groups have died at a higher proportion and once infected are more likely to die. Secondly, the 'Black lives matter' movement has sparked large gatherings in urban areas providing a secondary psychological effect and likely increased infections amongst these communities.

Strengths and Limitations
The collaborative effort with 50 NHS organisations, universities and charities is a key strength of the study. This will allow a representative sample from a wider geography. The two-staged approach of implementing the survey again in six months will allow an analysis of change. The global aspect of the study will allow an evaluation of the cultural and political landscape influencing the differences in the psychological impact of the pandemic.
The survey has used a convenience sample and therefore relies on a self-selected group of respondents who choose to complete the questionnaire. As this is a participatory study, numbers will depend on people willing to participate. However, there has been a good response so far, and we anticipate a large sample size.
Another limitation of the study is that there is no control with a number of outcomes.
As we have a two-staged approach, there will be some potential to evaluate change over time.

Future Research
The results presented in this paper are initial responses and are likely to change as the sample size increases. We hope to gain more recruitment from the general population, and a revised communication strategy will be instrumental based on the initial results. Temporal changes will be interesting to analyse as the participant demographics may change, and responses may change based on the political and government guidance. The possibility of delayed psychological impact of the pandemic due to economic and other changes or delayed realisation of how individuals had been feeling during the height of the crisis is also a possibility. We will therefore also be able to see correlations to other events that may coincide with data collation, such as mass gatherings, PHE publications, or other future national or international events.
Future research will need to consider interventions to support individuals who report adverse psychological impact of the pandemic and its resultant restrictions.
Improving populations' resilience and preparedness to crisis will also need to be a priority.

Conclusion
Evidence has shown an adverse psychological impact of previous pandemics on the population, especially non-healthcare professional's wellbeing, not only during the pandemic but also in long term. Research should focus on identifying the need, preparing services, and determining the factors that enhance and build resilience.  https://digital.nhs.uk/data-and-information/publications/statistical/nhs-workforcestatistics/september-2019 (accessed 10June2020).
Public Health England, 2020. Disparities in the risks and outcomes of COVID 19.