Best Practices in Perinatal Mental Health During COVID-19

April 28, 2021 updated by: Ana Mesquita, University of Minho

Best Practices in Perinatal Mental Health During COVID-19 Pandemic: A Collaborative Research Study Between the COST Actions RISEUP-PPD and Devotion

The COVID-19 pandemic has caused changes in health care during pregnancy, childbirth and postpartum. Although adverse effects of COVID-19 on perinatal mental health have been documented, changes in the perinatal mental health care provided to women and their families are yet to be established. As a Task Force in Perinatal mental health and COVID-19 pandemic within RISEUP-PPD COST Action, we aim: (i) to identify policies, guidelines and protocols from different European countries concerning the provision of perinatal mental health care in face of COVID-19, and (ii) to select the best practices to alleviate the negative impact of COVID-19 on perinatal mental health. The survey will be conducted among experts in perinatal mental health who are members of the COST Action RISEUP-PPD and COST Action Devotion in 36 European countries. The experts will fill in the online survey designed for this study that includes a series of open-ended questions, checklists, and response ratings on a 7-point scale. The topic areas cover seven domains of interest: 1) mental health policies, guidelines, protocols, and documents; 2) mental health care practices; 3) best practices; 4) barriers; 5) resources; 6) benefits; and 7) short- and long-term expectations. Data analysis will be mainly a qualitative analysis of the experts' professional views and opinions about the policies, guidelines, protocols, and documents regarding perinatal mental health changes in their country. Additionally, a basic quantitative descriptive analysis will be conducted.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that has caused worldwide pandemic since the breakout from Wuhan, China in December 2019. It has infected more than 71.5 million people, causing 1.6 million of deaths up to mid of December 2020.

Perinatal health care practices have been changed for safety reasons due to the pandemic and are still changing locally according to the epidemiological circumstances. Across Europe antenatal classes have ceased or have been provided online, antenatal regular check-ups are somewhat reduced or offered via telephone, the presence of the supporting person during childbirth is often not allowed in a maternity ward, visits of the father and other family members to the hospital after delivery are reduced or restricted, newborns of infected mothers are sometimes separated, home visits of a midwife after birth and breastfeeding support are also reduced (COST Devotion). Although official and national guidelines for perinatal health in general or infected mothers/newborns may be available, practices have been changing constantly, some of which may not be evidence-based or are in contradiction with the recommendations. Along with these changes, there are general restrictions, such as distancing from others, restricted socializing, and restricted movement, which may be necessary but can impose substantial psychological distress.

The high impact of COVID-19 on maternal mental health during pregnancy and postpartum has been evident in different countries worldwide. All these changes due to COVID-19 pandemic and related epidemiological measures were necessary to combat the spread of the virus but lead to an adverse effect on perinatal mental health.

Within the ongoing COST Action Research Innovation and Sustainable Pan-European Network in Peripartum Depression Disorder - RISEUP-PPD, funded by the European Cooperation in Science and Technology (COST Association), the special Task Force Perinatal mental health and COVID-19 pandemic, in collaboration with the COST Action Perinatal Mental Health and Birth-Related Trauma: Maximising best practice and optimal outcomes - Devotion, has been established with the main aim of investigating the best practices and guidelines to alleviate the negative consequences of COVID-19 on women's mental health (RISEUP-PPD COST Action). A recent review pointed out emerging issues in the prevention, diagnosis, and treatment of peripartum depression, which are highlighted even more with the ongoing pandemic. The Task Force has already addressed the deleterious impact of COVID-19 on perinatal mental health, the risk factors for mental health vulnerability during the current pandemic and highlighted good psychological practices in perinatal mental health during the COVID-19 pandemic. The Task Force pointed out that research on good practices in perinatal mental health in the time of COVID-19 pandemic should (i) capture the wide range of psychological distress presentations, focusing on depression and anxiety, (ii) look into complex roles of physical distancing and social isolation due to epidemiological measures, (iii) take into account the barriers in seeking help augmented by the pandemic that may be overcome by new e-health services, (iv) investigate changes in perinatal healthcare practices and factors that may alleviate them, and finally (v) boost the efforts for further development and validation of specific perinatal mental health assessment tools.

However, it remains yet to investigate what are the good practices in perinatal mental health and how have those been incorporated in the national policies, guidelines, protocols, and official documents across European countries during the COVID-19 pandemic. This has important clinical implications and can be used to inform policymakers at both the national and the European level - with the ultimate goal of providing the adequate support to women in the peripartum period and promote a pleasant experience for mothers and their families during pregnancy, delivery and the postpartum, in particular challenging situations as it is the case of the present COVID-19 pandemic. The main aim of this study is to identify the best practices to alleviate the negative impact of COVID-19 itself and the related safety measures (in health care facilities) and to promote mental health support during perinatal period. The secondary aim is to identify the themes emerging from the experts' opinions on changes due to COVID-19 pandemic in 1) mental health policies, guidelines, protocols, and documents; 2) mental health care practices; 3) best practices; 4) barriers; 5) resources; 6) benefits; and 7) short- and long-term expectations.

Methods and analysis Study design A cross- sectional study will be conducted in order to identify best practices in perinatal mental health during the COVID-19 pandemic.

Participants The participants will be experts in perinatal mental health who are the members of the COST Action RISEUP-PPD and the COST Action Devotion. The COST members are applied sciences researchers and clinicians (nurses, midwives, clinical social workers, general practitioners, Obstetrician/Gynaecologist, psychiatrists, clinical psychologist, psychotherapists), added by researchers from other backgrounds such as neuroscience, biology, biomedical engineer, mathematics and statistics, etc.), politicians, decision-makers, peer-support groups, stakeholders. The main aim of the RISEUP-PPD is to gather a multidisciplinary network of researchers to collect and profound the knowledge about prevention, assessment, and treatment in peripartum depression, while Devotion is dedicated to minimising birth trauma and optimising birth experiences. Taken together, both COST Actions include representatives from 35 European COST countries (Albania, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom), Israel as a Cooperating Members, and Brazil, the USA, Canada and Australia as International Partner countries.

As mainly qualitative data is planned to be collected, no calculation on sample size is necessary.

Instruments Demographic and expertise background questionnaire The Demographic and expertise background questionnaire will comprise questions on the area of specialisation (Nurse, Midwife, Clinical social worker, General practitioner, Obstetrician/Gynaecologist, Psychiatrist, Psychologist, Psychotherapist, Other), academic background and degree, job position in the current institution, years of experience and years working in Perinatal Care and/or Perinatal Mental Health (each with categories: up to 1 year, 2-5 years, 5-10 years, more than 10 years), current employer (tick all that apply: public, private, birth centre, hospital, home birth, primary care service, academic/research, counselling office, non-governmental organization, other), number of patients/clients per year per institution and personally, gender, age and country.

Questionnaire for experts on perinatal mental health practices during the COVID-19 Pandemic A questionnaire for the consultation of experts was developed by the research group of the Task Force "Perinatal Mental Health and COVID-19 pandemic", based on the previous questionnaire for experts on mental health used in Europe. The questionnaire includes a series of open-ended questions, checklists, and response ratings on a 7-point scale (1 = not adequate to 7 = excellent) with specific references to the change of policies, protocols, and practices regarding Perinatal Mental Health during COVID-19 pandemic. The topic areas covered seven domains of interest: 1) mental health policies, guidelines, protocols, and documents; 2) mental health care practices; 3) best practices; 4) barriers; 5) resources; 6) benefits; and 7) short- and long-term expectations.

Guidelines are defined as systematically developed recommendations to assist in practitioner and patient decision making about treatments for clinical conditions. Protocols are a comprehensive set of criteria outlining the management steps for a single clinical condition. Documents are defined as official records that provide information or evidence. Finally, Best Practice is defined as a technique or methodology that through experience and research has proven reliably to lead to the desired result.

The survey was written in English and a pilot study with three experts in perinatal mental health was conducted. Questions for pilot are presented in Table in Appendix 1. Amendments to the questionnaire were made accordingly which included rewording questions to elicit appropriate responses. The questionnaire for key experts can be found in Appendix 2.

Procedure Experts from COST Action RISEUP-PPD and COST Action Devotion will be approached by e-mail invitation to participate in the study. In order to have greater representation, the research group will encourage that, at least, the three experts per country with more expertise received the invitation.

Experts will be asked to complete the questionnaire online (Qualtrics platform). First, they will read an electronic consent form presenting an overview of the study aims, content of the questions asked, potential risks and benefits, and ethical aspects of the study (i.e., voluntary participation, confidentiality and secure storage of the data, and absence of any type of compensation). At the bottom of the form, they will be asked to confirm a eligibility criteria (members of either COST Actions) and to provide their consent to participate in the study. Participants who do not meet the predefined inclusion criteria will be directed to a message thanking them for their interest and informing them of the required eligibility criteria for participation in the study. The questionnaires are estimated to take approximately 15-20 minutes to complete.

Data analysis Data analysis will be mainly a qualitative analysis of the experts' views and opinions about the policies, guidelines, protocols, and documents regarding perinatal mental health changes in their country. The analysis will be made across the seven dimensions: 1) mental health policies, guidelines, protocols, and documents; 2) care practices; 3) best practices; 4) barriers; 5) resources; 6) benefits; and 7) short- and long-term expectations. Two authors will develop the coding plan, which will be checked by other authors. Two authors will code all answers to the open-ended questions independently. Inter-rater reliability will be calculated by Cohen's kappa coefficient and all disparities will be discussed to the agreement.

Additionally, a basic quantitative descriptive analysis will be made to estimate how many experts think that the policies, guidelines, or protocols regarding perinatal mental health have changed since COVID-19 outbreak, including percentages of yes/no answers and central tendency/variance on 7-point scale answers.

The findings from this study will be disseminated as papers published in peer-reviewed journals, presented at national and international conferences, and most importantly, its results will be used inform policymakers and have an impact on the changes in perinatal mental health care on a national and European level.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Experts in perinatal mental health who are the members of the COST Action RISEUP-PPD and the COST Action Devotion

Description

Inclusion Criteria:

  • experts working in perinatal care services within the COST actions RISEUP-PPD and Devotion

Exclusion Criteria:

  • COST members working in perinatal mental health less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in perinatal best practices
Time Frame: March 2020- June 2021
Questionnaire on changes in perinatal mental health care practices during the COVID-19 Pandemic
March 2020- June 2021
Changes in perinatal mental health protocols
Time Frame: March 2020- June 2021
Questionnaire on changes in perinatal mental health care practices during the COVID-19 Pandemic
March 2020- June 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Collaborators

University of Coimbra
Universidad Loyola Andalucia
Catholic University of Croatia

Investigators

  • Principal Investigator: Ana Mesquita, PhD, University of Minho
  • Principal Investigator: Emma Motrico, PhD, University of Loyola
  • Principal Investigator: Sandra Nakić Radoš, PhD, Catholic University of Croatia
  • Principal Investigator: Ana Ganho, PhD, University of Coimbra
  • Principal Investigator: Joan Lalor, PhD, Trinity College of Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2021

Primary Completion (ANTICIPATED)

July 30, 2021

Study Completion (ANTICIPATED)

September 30, 2021

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (ACTUAL)

March 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RISEUP-PPD-DEVOTION- COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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