MIND/COVID-19: Mental Health Impact and NeeDs Associated With COVID-19: a Comprehensive National Evaluation in Spain

Background

Previous research on infectious disease outbreaks found substantial mental health impact
among cases placed under isolation or quarantine, among those working in the various
healthcare systems managing the outbreaks, and in the general population. Mental
disorders expected to rise during and after viral outbreaks include anxiety disorders,
especially post-traumatic stress disorder, as well as depression, and suicidality.

Justification

The magnitude of the ongoing 2019 novel coronavirus disease (COVID-19) pandemic points to
the urgent need to quantify mental health impact of the outbreak. Epidemiological
research enables rapid health needs assessment to benchmark and monitor the ongoing onset
and persistence of adverse mental health outcomes in the population, and to provide
situational awareness, i.e., essential information to understand current and midterm
mental healthcare needs, plan adequate responses, and allocate appropriate resources. The
project is part of an ongoing international effort to collect cross-nationally comparable
data on the mental health impact of the COVID-19 pandemic (World Mental Health Surveys).

Hypotheses:

1. Adverse mental health outcomes, such as symptoms of depression and anxiety(1),
post-traumatic stress disorder, and suicide, will increase from the onset of the
COVID-19 outbreak, compared to the previous mental health status. The most
pronounced increase will be in vulnerable groups, i.e., among recently isolated or
quarantined individuals and healthcare workers.

2. Working as healthcare worker, having been quarantined, having family members dead by
COVID19 will be some of the substantial risk factors to develop sub-sequent high
levels of adverse mental health. Also, some preoutbreak individual characteristics
will be predictors of the mental and psychological health impact, such as the level
of formal education or having a history of psychiatric illness.

3. A substantial part of the participants would require mental health services and some
type of psychological support. Most of the subjects reporting symptoms will not be
using the already available resources.

OBJECTIVES

The primary objectives of the proposed project are to:

1. assess the mental and psychological health impact of the COVID-19 outbreak among
cases or close contacts recently isolated or quarantined, healthcare workers and the
general population

2. identify risk and protective factors for adverse mental health onset and
persistence;

3. quantify the use of available mental health resources;

4. quantify and characterize unmet mental healthcare needs. These objectives will be
achieved both at the short-term (onset and bi-weekly surveys) and the medium term (6
months).

The secondary objectives of the proposed project are to:

1. assess the potential benefits of using available mental health resources;

2. provide a reference point (benchmark) and evolution over time for future long-term
research on COVID-19 related mental and psychological health impact in the
population.

Study population and recruitment

Three separate population groups will be assessed: (1) recently isolated or quarantined
COVID-19 cases and close contacts; (2) healthcare workers, including medical personnel
directly and indirectly involved with patients as well as other personnel (e.g.
administrative workers) and (3) a representative sample of the general adult population
(including those tele-working and working outside of home).

Even though the terms quarantine and isolation are often used interchangeably, here we
differentiate them following Brooks et al. According to this, Quarantine is the
separation and restriction of movement of people who have potentially been exposed to a
contagious disease to ascertain if they become unwell, so reducing the risk of them
infecting others, and Isolation is the separation of people who have been diagnosed with
a contagious disease from people who are not sick. Finally, we use the term confinement
to define the situation of the population in Spain who, in order to prevent further
spread of the virus, has been restricted to stay at home, and is only allowed to get out
for specific tasks that need to be justified.

Calculation and justification of the sample size

General population: a fixed sample size of n= 3,500 ensures a two-sided 95%CI of 0.025
for a sample proportion of 0.20. Health professionals: up to 85,000 professionals work in
the participating institutions (30,000 at primary health care centers, 55,000 at
hospitals). Assuming a 15% participation rate, we expect a sample size of >10,000.
COVID-19 cases: Given high numbers of (hospitalized) cases in Barcelona and Community of
Madrid (the main recruitment areas) and the population coverage of the participating
institutions, we expect to recruit n=2,000 cases and close contacts. Within each
population subgroup, a sample of at least 2,000 individuals achieves power > 0.80, with
alpha=0.05, to detect an odds ratio of 1.6 on a binary independent variable (of which 30%
are in the group X=1) from a multivariable logistic regression (with R2 < 0.3 between X
and remaining independent variables). An overall sample of 16,000 achieves power > 0.90
to detect an odds ratio of 1.2 under the same conditions.

Study methodology/Procedures

Adult population groups 1 (cases and close contacts) and 2 (healthcare workers) will be
assessed at baseline using web-based self-report surveys (with response time ~15 minutes)
including both common and specific modules (specific for groups 1 & 2). People with
unavoidable limitations to answer the webbased questionnaire will also be eligible to
participate in the study. In this case, the interview will be conducted by telephone. The
telephone interview will be carried out from the same center or may be outsourced,
subject to the patient's consent to share his/her contact details. Additionally, upon
completion of the baseline survey, group 1 (cases and close contacts) and group 2
(healthcare workers) will be invited to respond very brief bi-weekly surveys (response
time 3 - 5 minutes) on a maximum of 4 occasions to prospectively assess adverse mental
health and the use of available resources to counter mental health impact. General
population participants will be assessed through telephone interviews. All baseline
participants of the 3 adult population groups will be assessed at 6 months follow-up
using web-based self-report surveys or telephone interviews similar to their baseline
assessment. At follow-up, groups 1 and 2 will also receive more extensive clinical
screeners that allow to accurately assess common psychiatric disorders.

Analyses

The data will be pseudo-anonymized through encrypted identifiers, separating the personal
information from the rest of the study data, to guarantee privacy and ensure the
anonymized treatment of the data in the analysis.

Descriptive statistics of mental health status, mental health service use, and use of
available resources at baseline and 6-month follow-up, and bivariate associations of
these outcomes with potential risk and protective factors are estimated, stratified by
population groups.

Bi-weekly brief survey data will be analyzed using time-lagged multilevel models and
network analysis to estimate the associations of short-term dynamic risk and protective
factors with mental health status and use of resources.

Multivariable generalized linear models will be used to identify baseline risk and
protective factors for onset and persistence/deterioration of adverse mental health
outcomes at follow-up. Potential benefits of use of available resources on preventing
onset or persistence of adverse mental health outcomes will be analyzed using propensity
scores methods to address the lack of baseline randomization and likely imbalance between
treatment groups (natural experiment research design). All analyses will adjust for
time-of-survey.

Multiple imputation methods will be used to deal with missing values.

LIMITATIONS AND RISK AND CONTINGENCY PLANS

The established network of collaborators we already have in place guarantees adequate
recruitment of otherwise hard-to-reach groups 1 and 2 (cases and close contacts,
healthcare workers). The lack of randomized sampling of surveillance agencies and
healthcare facilities may affect representativeness of findings; this limitation will be
countered by statistical weighting techniques based on all information available a
posteriori in centralized national case register and healthcare facility data. Response
rates will be maximized by repeated invitations and reminders.

ETHICAL CONSIDERATIONS AND CONFIDENTIALITY

The study is in line with the principles established by national and international
regulations, including the Declaration of Helsinki (64th WMA General Assembly, Fortaleza,
Brasil, Oct 2013) and the Code of Ethics. The project will start upon approval by the
independent PSMAR Clinical Research Ethics Committee (PSMAR-CEIm). Recruitment in
collaborating institutions will be initiated only after project approval by its
corresponding ethics committee, whenever additional approval is required.

All personal data will be handled following Regulation (EU) 2016/679 of the European
Parliament and of the Council of 27 April 2016, and the national Organic Law 3/2018, of
December 5. All participants will provide explicit informed consent. When participants
access the link to the online questionnaire platform, the participant's information form
specific for the subpopulation they belong to will appear in the first screen, which will
be written in understandable language, and will describe in clear language the aims,
methods, and implications of the research. At the end of the information about the study,
the different points of the informed consent will be presented in the form of check
options that will have to be clicked. Access to the questionnaire will only be allowed if
all check options have been activated.

The answers to the different consent questions will be stored in the database, together
with the other responses, and may be used as evidence that the participant did, indeed,
consent. Exemption from obtaining a signed informed consent has been requested, given the
observational, online data collection nature of the study and given the fact that, to be
able to access the questionnaire, respondents will have to actively check all consent
questions

The Qualtrics survey platform (web-based surveys; qualtrics.com) will be used for data
collection in subpopulations of cases and close contacts (1) and healthcare center
workers (2). This platform has three of the most important security certifications:
FedRAMP, ISO 27001 and HITRUST Common Security Framework (CSF), to meet the security
requirements of the most regulated industries and organizations and those of the RGPD
(European General Data Protection Regulation). In addition, the platform has additional
technology that allows the user to also comply with this regulation (GDPR OneTouch Data
Deletion). The data collected through the platform is stored in servers located in the
EU. All data stored in the EU data center is encrypted via the AES256 cypher standard.
All data transmitted to the Qualtrics platform is encrypted via the industry standard
protocol TLS 1.2 and higher. The only personal information that will be requested to
participants in the study are contact details with the solely objective to be able to
invite participants to the follow up surveys and to send reminders within the framework
of the project. This personal data will be collected within the questionnaire, once the
participant has given his or her consent to participate in the study. The data will be
pseudo-anonymized and neither the study investigators nor the persons in charge of the
analysis will have access to the personal data. Only the data manager designated for the
study will be able to relate the personal data of the participants to the questionnaire
responses. All data will be collected in a research file under the responsibility of the
institution, will be considered confidential and will only be used by researchers for the
purposes of the project. A Data Protection Officer involved in all stages of data
processing has been appointed, DPO: protecciodedades@imim.es).

With regard to the Adult General Population sample (subpopulation 3), the external
company IPSOS survey company (web-based surveys; ipsos.com), will be in charge of
selecting the sample, inviting participants to the study and carrying out the interviews.
A verbal informed consent to participate will be obtained: at the beginning of the
contact call, a presentation text with information on the study will be read, and
explicit consent will be asked to the participant to respond a questionnaire in two
different occasions, baseline and after 6 months. This part of the call where explicit
informed consent is requested will be recorded and stored. . At the end of the 6-month
follow-up interview, participants will be asked again for verbal recorded consent asking
permission for the company to provide contact details of the participant to the study
investigators, so that investigators can recontact them for eventual subsequent follow up
assessments of the study. IPSOS will ensure that personal data of the participants will
be treated with the maximum confidentiality measures according to the current regulations
in force (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27
April 2016, and the national Organic Law 3/2018, of December 5), and that personal data
will be exclusively used within the framework of this study. IPSOS data protection policy
is detailed in the following link:
https://www.ipsos.com/sites/default/files/201804/Global_Data_Protection…
y.pdf.

A specific survey platform developed by IPSOS will be used in this group. IPSOS complies
with all relevant regulations for the industry, including the new EU directive: GDPR, but
also with the ethical, privacy and anti-spam precepts recommended by European Society for
Opinion and Marketing Research (ESOMAR). The extensive privacy policy is displayed during
the registration process and must be accepted by all the panelists. To this end, Ipsos
applies strict data protection and security protocols for both client and respondent
data. Physical security measures include strict control of access to data centers,
firewalls, antivirus procedures, data retention/destruction policies, or disaster
recovery plans.

Given the observational approach of the study, without therapeutic intervention, it is
considered that it will pose minimum risk to the respondents. Participants with
psychological distress will be provided with a list of effective care resources at the
end of the questionnaire, including coordinates to nearby emergency care in case of
suicidal symptoms.