Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04556565 |
| Other study ID # |
2020/9203/I |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 8, 2020 |
| Est. completion date |
November 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Hospital del Mar Research Institute (IMIM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of the proposed project is to provide a comprehensive assessment of the mental health
impact of the ongoing COVID-19 outbreak in Spain. A prospective cohort study of three groups
will be conducted: (1) COVID-19 cases or close contacts recently isolated or quarantined; (2)
healthcare workers; (3) adult general population.
Recruitment through epidemiologic surveillance services, hospitals, primary care centers in 6
Spanish Autonomous Communities (groups 1 & 2) and a random sample of individuals using
telephone numbers as the sampling frames(group 3). Web-based surveys or telephone interviews
at baseline and 6-month follow-up assess: current living and employment status; COVID-19
infection status; mental health (post-traumatic stress, panic, depression, anxiety, alcohol
and substance use, suicidality; services use); psychological functioning; general health
status and quality of life. Specific modules focus on isolation or quarantine (group 1) and
care for COVID-19 patients (group 2). Short bi-weekly brief follow-up surveys among groups 1
& 2 will provide additional assessment of main outcomes in the two months following baseline
assessment.
Description:
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_and_Privacy_Policy.pd
f.
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.
