Impact of COVID-19 Pandemic in Perinatal Mental Health (RISEUP-PPD-COVID-19)

This study is co-sponsored by University of Loyola, Seville, Spain and from University of
Minho, Braga Portugal. Emma Motrico and Ana Mesquita as Principal Investigators of the study
are the Responsible Parties.

Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by
the World Health Organization that appeared more benign for pregnant women than for their
newborns. COVID-19 pandemic is causing fear, anxiety and depression in the population. At the
same time, pregnancy and postpartum is a period of increased risk for mental illness. It is
estimated that 1 in 5 women will develop a mental illness in the perinatal period. Perinatal
depression is the most common mental illness experienced during pregnancy and postpartum and
has long-lasting adverse effects on women and their babies, bringing a strong burden to their
families and society as a whole. The current COVID-19 pandemic is a unique stressor with
potentially wide-ranging consequences in the perinatal period. Evidence coming from past
epidemics, namely ZIKV infection (Zika virus) highlight the importance of examining mental
health in light of stressful events experienced during pregnancy and the postpartum period
and of long-term support for these mothers. There has been an increase in the prevalence of
perinatal depression, anxiety and psychological distress after the announcement of the
SARS-CoV-2 outbreak.

The project Research Innovation and Sustainable Pan-European Network in Peripartum Depression
Disorder - Riseup-PPD" (CA18138) is a Cost Action (European Cooperation in Science and
Technology) funded by the Horizon 2020 Framework Programme of the European Union. The project
aims to establish a European multidisciplinary network of experts dedicated to the
understanding of Peripartum Depression (PPD), from its prevention and assessment to its
treatment and evaluation of impact, considering the women, the newborns and the wider family
and social systems. Researchers from different core expertise (clinical medicine, psychology,
health sciences, mathematic, media and communications) from 23 European countries and six
international countries participate in the COST Action Riseup-PPD. In order to promote best
practices in perinatal mental health that may mitigate the impact of COVID-19 management in
women's mental health, the COST Action Riseup- PPD has decided to create a new Task Force
"Perinatal Mental Health and COVID-19 pandemic". One of the main objectives of this
crosscutting Task Force is to evaluate the impact of COVID-19 on perinatal mental health.
Aims: Test the hypothesis that COVID-19 pandemic is associated with increased perinatal
mental illness.

Methods Study design: Prospective observational study, with a baseline assessment and three
follow-ups: one-month; three months; and six-months.

Setting: 11 European countries - Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta,
Portugal, Spain, Turkey, United Kingdom - Chile and Brazil. Participants: Pregnant women and
new mothers with an infant under six months of age. Data from additional countries could also
be include in the future to this study, if using the same instruments.

Study size: A representative sample was calculated according to number of newborns in the
previous year in each country. The investigators estimate a minimum group size of 300 women
per country. The estimation is based on an α-level of 0.05 and heterogeneity equal to 50%.

Variables and questionnaires Predictor variables/independent variables:

COVID-19 and Public health measures. Data on COVID-19 includes for each country (1) date of
first confirmed case, (2) date of first death, and (3) at the date of questionnaire release:
(3.1) number of confirmed cases, (3.2) number of recoveries (3.3) number of deaths. Data on
public health measures adopted to contain the COVID-19 pandemic will include date and
guidelines for (1) general restrictions (events, sports, religious ceremonies); (2) home
confinement; (3) social distancing; (4) schools and services closing; and (5) restrictions to
circulation within the country and between countries (including external border closure).
Data on the deconfinement plan, including (1) general deconfinement (events, sports,
religious ceremonies); (2) rules for circulating in public transport and services (including
mandatory use of face masks); (3) schools reopening; and (4) services reopening.

Sociodemographic variables: date of birth, ethnicity, education, marital status, residence
and questions about number of people living at home and numbers of weeks in confinement.

Coronavirus Perinatal Experiences Impact Survey (COPE-IS) - perinatal experiences; exposure
and symptoms; financial impact; social support impact; social distancing and activity
restriction; coping and adjustment; emotional impact; health background, mental health, and
substance use.

In the follow-up assessments, experiences of new and expectant mothers will be measured with
the Coronavirus Perinatal Experiences Scale-Impact Update (COPE-IU) and the Coronavirus
Perinatal Experiences Scale - Care Follow Up (COPE-CF). The COPEIU evaluates exposure to
COVID-19 and symptoms; impact on daily life, experiences, and feelings; the COPE-CF evaluates
perceived support and care and the social and financial impact of the pandemic.

Perinatal experiences: Includes questions about if it is/was her first pregnancy, health
problems during pregnancy, type of pregnancy, pre and postnatal care support, resources
available from pre and postnatal care, changes experienced as a result of COVID-19 and
question related to concerns about changes in family/friends support, medical care during the
baby´s birth and child´s health as a result of the COVID-19 outbreak. Specifically, for women
of a child younger than six months, this also includes other questions about city and place
of birth, breastfeeding, changes experienced in birth plans and level of distress experienced
related to changes in baby´s birth and postnatal experiences. Exposures and symptoms:
Pregnant women/ new mothers and their family have been exposed to or are experiencing any
symptoms like those seen in COVID-19. This includes questions about the diagnosis of
COVID-19, symptoms compatible with coronavirus, contact with someone who has been diagnosed
withCOVID-19, anyone close died due to COVID-19, and the degree of distress about COVID-19
related symptoms or potential illness. Financial impact: type of employment, impact of the
pandemic on future employment and financial impact of the COVID-19 outbreak.

Social support impact: Support seeking, support provided, need for support, perceived
support, and level of distress experienced with disruptions to social support due to the
COVID-19 outbreak.

Coping and adjustment: Includes 23 coping strategies (problem-focused or emotion-focused) in
response the stress related to the COVID-19 outbreak.

Emotional impact: Impact of COVID-19 on mental health - subjective impact of the COVID-19
outbreak on stress levels and mental health, sleep, and daily energy levels and the positive
and negative impacts of the COVID-19 outbreak on daily life.

Health background, mental health, and substance use: Five mental health and substance use
questions from the John's Hopkins COVID-19 Mental Health Measurement Working Group: 1) the
woman's history of medical conditions; 2) household history of medical conditions; 3) current
mental illness; 4) current substance use; and 5) treatment of medical conditions.

Psychological distress using the Brief Symptom Inventory-18 (BSI-18), omitting suicidality.

Dependent/outcome variables: Maternal and perinatal mental health outcomes will be evaluated
- depression, anxiety and Posttraumatic Stress Disorder (PTSD), Measurements include the
Edinburgh Postnatal Depression Scale (EPDS), the Generalized Anxiety Disorder Screener
(GAD-7), a subset of 10 questions from the Posttraumatic Stress Disorder (PTSD) Checklist for
DSM-5 related with COVID-19 included in COPE-IS and COPE-IU questionnaire [

(1) Feeling super alert or watchful or on guard; 2) Feeling jumpy or easily startled; 3)
Having difficulty concentrating; 4) Trouble experiencing positive feelings; 5) Feeling guilty
or blaming yourself; 6) Feeling irritable, angry or aggressive; 7) Repeated disturbing and
unwanted thoughts about the COVID-19 outbreak; 8) Repeated disturbing dreams about the
COVID-19 outbreak; 9) Trying to avoid information or reminders about the COVID-19 outbreak;
and 10) Taking too many risks or doing things that could cause the participants harm]

Data collection: Participants will be recruited through social media (Twitter, WhatsApp,
Facebook and Instagram, Reddit, Researchgate, Linkedin, Ya, etc.), networks of organizations
(including universities, health centers, NGOs working on the field of perinatal mental
health), policymakers, local organizations, and other stakeholders. Participants will also be
recruited directly by message or email.

Participants are provided with a link to a digital survey that will direct them to an
electronic consent form that provides an overview of what to expect and states that
participation is voluntary, the purpose of research, possible risks, possible benefits,
confidentiality protection, and appropriate alternatives. The baseline assessment is
anticipated to be 20 minutes long. Eligible participants who complete the initial survey will
be asked to participate in follow-up assessments.

Participation in the follow-ups will be optional and participants will have to provide their
consent to be contacted by email or phone; attached to this request the investigators will
provide a clear plan to protect confidentiality of information and contact information data
protection plan (this will also be provided in the Informed Consent).

Ethical standards and safety monitoring: The study and handling of the data will follow all
national required data protection standards. Each researcher (or team of researchers)
involved will submit the project to local ethical committee before starting the project.
Participants are provided with a link to an informed consent form before starting the study.
If they agree to participate, only then will they proceed to the online survey. The consent
form provides an overview of the aims of the study, what to expect and explains how
confidentiality will be protected. Clarification of the voluntary nature of participation in
the survey and of absence of compensation will be provided. Data should be collected
anonymously, although email or/and phone number will be necessary for the follow-up
assessments. Inclusion of vulnerable subjects is justified for this study because the purpose
of the study is to examine pregnant or breastfeeding women. The research contains negligible
risks as there is no more foreseeable risk of harm or discomfort other than potential
inconvenience during participation. The study does not include deception, but some questions
of the survey can elicit changes in the emotional state of participants. In order to address
this issue, a debriefing procedure will be made available; at the end of the survey,
information about resources in each country on mental health, perinatal care and COVID-19 as
well as contacts of the research team will be given in case participants would like to have
additional information. Information about the global results of the study will be provided
upon request.