Clinical trial NCT04595123: Impact of COVID-19 Pandemic in Perinatal Mental Health (RISEUP-PPD-COVID-19)
Official title: Impact of COVID-19 Pandemic in Perinatal Mental Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Traumatic Stress Disorder
Depression
Anxiety
Psychological Distress
Keywords: Perinatal mental health
Women
Anxiety
Depression
COVID-19
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Universidad Loyola Andalucia
name: Beder College University. Albania
name: Mackenzie Presbiterian University, São Paulo, Brazil
name: Medical University of Sofia
name: European University Cyprus
name: Groupe Hospitalier du Havre
name: University of Athens
name: Bar-Ilan University, Israel
name: University of Malta
name: Mount Carmel Health System
name: University of Coimbra
name: Universidade Católica Portuguesa
name: Instituto de Saude Publica da Universidade do Porto
name: University of Huelva
name: Instituto de Investigação Biomédica de Malaga. Spain
name: Universidad Nacional de Educación a Distancia
name: Kırklareli University
name: King's College London
name: Universidad de Concepcion
First posted: 2020-10-20
Enrollment: 7642
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is pregnant women and new mothers with an infant under six months of age. The rationale is to evaluate during the six-month follow-up the "peripartum period", from pregnancy to one year following childbirth

Brief summary: Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: 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 their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant or biological mother of a child six months old or younger
* 18 years of age or older
* Live in one of the countries of the study
* Accept to participate in the study

Exclusion Criteria:

* Not pregnant and not biological mother of a child 6 months old or younger
* Younger than 18 years old
* Not live in one of the countries of the study

Primary outcomes:
measure: Depressive symptoms
timeFrame: June 2020- June 2021
measure: Posttraumatic Stress Disorder
timeFrame: June 2020- June 2021
measure: Anxiety symptoms
timeFrame: June 2020- June 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: Beder College University
city: São Paulo
country: Brazil
facility: Universidade Presbiteriana Mackenzie
city: Sofia
country: Bulgaria
facility: Sofia University
city: Concepción
country: Chile
facility: Universidad de Concepción
city: Nicosia
country: Cyprus
facility: European University Cyprus
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
city: Athens
country: Greece
facility: University of Athens
city: Ramat Gan
country: Israel
facility: Bar-Ilan University
city: Imsida
country: Malta
facility: University of Malta
city: Braga
country: Portugal
facility: Universidade do Minho
city: Sevilla
country: Spain
facility: Universidad Loyola Andalucia
city: Kırklareli
country: Turkey
facility: Kırklareli Üniversitesi
city: London
country: United Kingdom
facility: King'S College London
Study officials:
affiliation: University of Minho
name: Ana Mesquita, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Loyola Andalucia
name: Emma Motrico, PhD
role: PRINCIPAL_INVESTIGATOR
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