Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic (MindCOVID)

Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.

Study Overview

• Status: Unknown
• Conditions: Depression; Anxiety; Pregnancy Related
• Intervention / Treatment: Other: Pandemic control measures

• Study Type: Observational
• Enrollment (Anticipated): 8500

Contacts and Locations

Study Locations

• Albania
  • Tirana, Albania
    • Recruiting
    • University of Medicine Tirana
    • Contact: Orion Gliozheni, MD
• Australia
  • Sydney, Australia
    • Recruiting
    • Royal Prince Alfred Hospital
    • Contact: Jon Hyett
• Czechia
  • Prague, Czechia
    • Recruiting
    • Charles University
    • Contact: pavel Calda, MD, MSc.
• France
  • Paris, France
    • Recruiting
    • Université de Paris
    • Contact: Laurent J Salomon, MD, PhD
• Germany
  • Berlin, Germany
    • Recruiting
    • Charité - University Medicine Berlin
    • Contact: Stefan Verlohren, MD, Professor
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Liona C Poon, MBBS, MRCOG, Professor
    • Contact: Equal Chen
• Israel
  • Kafr Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Tal Biron-Shental, MD
    • Contact: Maya Ben-Zion, MD
• Italy
  • Brescia, Italy
    • Recruiting
    • University of Brescia
    • Contact: Federico Prefumo, MD, PhD
• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • American University of Beirut
    • Contact: Gihad Chalouhi, MD, PhD
• Norway
  • Tromsø, Norway
    • Recruiting
    • The Arctic University of Norway
    • Contact: Heidi Tiller, MD, PhD
• Poland
  • Bydgoszcz, Poland
    • Recruiting
    • Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
    • Contact: Dariusz Borowski, MD, PhD
  • Szczecin, Poland
    • Recruiting
    • Pomeranian Medical University
    • Contact: Sebastian Kwiatkowski, MD, PhD
  • Warsaw, Poland
    • Recruiting
    • Centre of Postgraduate Medical Education
    • Contact: Anna Kajdy, MD, PhD; Phone Number: +489663769515; Email: akajdy@cmkp.edu.pl
• Spain
  • Madrid, Spain
    • Recruiting
    • 11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"
    • Contact: Maria del Mar Gil Mira, MD, PhD
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Institutet
    • Contact: Ganesh Archaya, MD, PhD, Professor
• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taiji Clinic
    • Contact: Ksenia Olisova, MD, MPH
• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University
      • Contact: Sonia Hassan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

About 10% of pregnant women experience perinatal depression globally. Untreated perinatal depression may result in adverse obstetric outcomes and is a risk factor for poor maternal health, inadequate prenatal care, and postpartum depression. In addition to the potential negative impact on pregnancy outcomes, perinatal depression is associated with disrupted maternal-infant bonding, increased irritability, and decreased activity. Children born to depressed mothers are at risk for delayed cognitive and language development, lower IQ, and increased prevalence of psychiatric and emotional problems. Depression that begins during pregnancy frequently continues or worsens after delivery.

Description

Inclusion Criteria:

• declaration of being pregnant
• being able to complete the survey in the available languages
• answer the screening questions
• provide informed consent for participation

Exclusion Criteria:

• not providing online informed consent for participation
• if the participant does not click on the submit button at the end of the survey
• not answer all the GAD-7 and PHQ-9 scale questions

Study Plan

How is the study designed?

Number of groups / cohorts

17

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Australia	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Poland	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Albania	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Czech Republic	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
France	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Germany	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Hong Kong	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Israel	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Italy	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Lebanon	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Norway	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Russia	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Spain	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Sweden	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Taiwan	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
Ukraine	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
United States	Other: Pandemic control measures; Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points	4 months
Depression	Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points	4 months

Collaborators and Investigators

• Sponsor: Żelazna Medical Centre, LLC
• Collaborators: Charles University, Czech Republic; Karolinska Institutet; Charite University, Berlin, Germany; Wayne State University; University of Tromso; Chinese University of Hong Kong; American University of Beirut Medical Center; Meir Medical Center; Pomeranian Medical University Szczecin; Nicolaus Copernicus University; Chang Gung University; Centre of Postgraduate Medical Education; Royal Prince Alfred Hospital, Sydney, Australia; Università degli Studi di Brescia; Hôpital Necker-Enfants Malades; Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland; University of Medicine, Tirana; Polish Academy of Sciences; Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid; Taiji Clinic, Taipei
• Investigators: Study Chair: Anna Kajdy, MD, PhD, Centre of Postgraduate Medical Education; Principal Investigator: Michał Rabijewski, MD, PhD, Professor, Centre of Postgraduate Medical Education; Principal Investigator: Dorota Sys, PhD, Centre of Postgraduate Medical Education; Principal Investigator: Jan Modzelewski, MD, Centre of Postgraduate Medical Education; Principal Investigator: Sebastian Kwiatkowski, MD, PhD, Pomeranian Medical University Szczecin; Principal Investigator: Roksana Lewandowska, MD, Pomeranian Medical University Szczecin; Principal Investigator: Dariusz Borowski, MD, PhD, Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz; Principal Investigator: Barbara Baranowska, PhD, RM, Centre of Postgraduate Medical Education; Principal Investigator: Artur Pokropek, PhD, Professor, Institute of Philosophy and Sociology of the Polish Academy of Sciences; Principal Investigator: Urszula Ajdacka, MD, Central Clinical Hospital of Ministry of Internal Affairs and Administration; Principal Investigator: Stepan Feduniw, MD, Żelazna Medical Centre; Medical Faculty od Lazarski University; Principal Investigator: Maria del Mar Gil Mira, MD, PhD, Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"; Principal Investigator: Simone Schwank, PhD M.S. M.A. Msc. Clinical Ps, Karolinska Institutet; Principal Investigator: Ksenia Olisova, MD, MPH, Taiji Clinic, Taipei; Principal Investigator: Tung-Yao Chang, MD, M Med Sci, Taiji Clinic, Taipei; Principal Investigator: Steven Shaw, Chang Gung University; Principal Investigator: Sonia Hassan, MD, Wayne State University; Principal Investigator: Jade Harris, MD, Wayne State University; Principal Investigator: Orion Gliozheni, MD, University of Medicine, Tirana; Principal Investigator: Jon Hayett, Professor, Royal Prince Alfred Hospital, Sydney; Principal Investigator: Pavel Calda, MD, MSc, Professor, Charles University; Principal Investigator: Laurent J Salomon, MD, PhD, Professor, Université de Paris; Principal Investigator: Stefan Verlohren, MD, Professor, Charite University, Berlin, Germany; Principal Investigator: Liona C Poon, MBBS, MRCOG, Professor, Chinese University of Hong Kong; Principal Investigator: Maya Ben-Zion, MD, Meir Medical Center; Principal Investigator: Federico Prefumo, MD, PhD, Universita degli Studi di Brescia; Principal Investigator: Gihad Chalouhi, MD, PhD, American University of Beirut Medical Center; Principal Investigator: Ganesh Acharya, MD, PhD, FRCOG, Professor, Karolinska Institutet; Principal Investigator: Heidi Tiller, MD, PhD, The Arctic University of Norway; Principal Investigator: Karine Stiberg Birkelund, The Arctic University of Norway; Principal Investigator: Solrun Rasmussen, The Arctic University of Norway; Principal Investigator: Ewa Andersson, RNM, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: depression; mental health; COVID-19; anxiety; pregnancy; coronavirus; pandemic
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Mood Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Depression; Depressive Disorder; COVID-19; Anxiety Disorders
• Other Study ID Numbers: Maternal axiety and COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No