Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04779775 |
| Other study ID # |
RISEUP-PPD-DEVOTION- COVID-19 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Minho |
| Contact |
Ana Mesquita, PhD |
| Phone |
+351253604613 |
| Email |
ana.mesquita[@]psi.uminho.pt |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
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.
