Official Title
Mental Health of Urban Mothers (MUM) Study: A Multi-center Randomized Controlled Trial
Brief Summary

Mental health disorders are common during pregnancy and the postnatal period, and can have serious adverse effects on the well-being of woman and child. Every tenth woman has depressive symptoms and 5% suffer major depression during pregnancy. The consequences for global mental health due to the novel coronavirus disease, COVID-19, are likely to be significant and may have long-term impact on the global burden of disease. Pregnant women may be particularly vulnerable due to partial immune suppression. Besides physical vulnerability, the women could be at increased risk of mental health problems, such as anxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancing leading to less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labor and delivery. Furthermore, many pregnant women may feel insecure and worried about the effect of COVID-19 on their unborn child, if the women get infected during pregnancy. Today, young urban women are used to utilizing internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via web-based support may be effective in ameliorating their anxiety/depression and reduce the risk of serious mental health disorders leading to improved maternal and perinatal outcomes.

Detailed Description

Pregnancy is a period of transition and great change, which may make some women more

vulnerable to mental health problems. It is known that depressive symptoms during pregnancy

may influence birth outcomes. Perinatal mental health disorders may become more prevalent

during a time of acute crisis, and the prevalence of maternal anxiety, distress, and

perinatal depression can be expected to increase globally, as a result of the COVID-19

pandemic. However, there might be cross-national differences in the risk factors and impact

of pandemic on the prevalence of perinatal mental health disorders.



Some pregnant women might be predisposed to posttraumatic stress disorder (PTSD) during a

crisis situation, such as the COVID-19 pandemic. Mothers who developed PTSD in response to

the 9/11 terrorist attacks had lower morning and evening salivary cortisol levels, compared

to mothers who did not develop PTSD. Beyond effects on the mother alone, perinatal mental

health issues can have long-term effects on child´s mental and physical health, as well as

the participants behavior and cognition. Distress in pregnant women may affect the fetus and

is known to induce epigenetic changes in the placental genes. Increased risk of

psychopathology is observed in children exposed to maternal prenatal distress. Elevated

maternal cortisol and epigenetic regulation of placental glucocorticoid-pathway genes are

potential mechanisms for these observations. Women often express feelings of inadequacy in

the new mothering role, which can furthermore negatively impact the participants mental

health and the relationship to the infant.



Effective treatments are needed to address high global rates of postpartum depression (PPD)

with onset typically within 4 weeks after delivery and maternal depression up to two years

after delivery. Programs aimed at reducing PPD could achieve the most cost-efficient results

by focusing efforts in the critical time periods around childbirth. Web-based psychosocial

support provided by trained public health nurses is an effective treatment method for PPD.

Limited public health resources are challenges to the accessibility of mental health

services, which is why the use of web-based psychosocial support could be a good alternative.

Women perceive the risk for themselves or their infants to be above average during global

crises, which increases the levels of uncertainty. However, face-to-face consultations during

a pandemic are likely to increase the risk of disease transmission. Therefore, easily

accessible eHealth support could provide fast and resource-effective care during the COVID-19

pandemic.



The study will generate evidence on whether web-based early intervention programs could be

efficient in ameliorating the risk and severity of perinatal mental health disorders, and

inform best clinical practice for women affected by the consequences of the COVID-19

pandemic.

Not yet recruiting
Perinatal Depression
COVID19
Anxiety
PTSD
Pregnancy Related

Behavioral: Web-based psychosocial peer-to-peer support
The evidence-based eHealth peer-to-peer psychosocial intervention "Thinking Healthy", will be tested in this RCT. In line with the World Health Organization's mhGAP Intervention Guide (mhGAP-IG), "Thinking Healthy" is used to identify and manage perinatal mental health conditions (distress, symptoms of depression, and anxiety) in non-specialized psychosocial support setting.
Standard perinatal care
Web-based psychosocial peer-to-peer support

Eligibility Criteria

Inclusion Criteria: - Pregnant women between 12 and 18 weeks of gestation - Viable intrauterine pregnancy.

Exclusion Criteria: - History of severe psychiatric - Substance abuse disorder - Requiring medical treatment - Presence of fetal chromosomal/structural abnormality

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years
Countries
China
Hong Kong
Contacts

Simone E Schwank, PhD
‭+41796137255
simone.schwank@ki.se

Ganesh Acharya, MD PhD
‭+46 70-099 63 35‬
ganesh.acharya@ki.se

Simone E Schwank, PhD
Principal Investigator
Karolinska Institute CLINTEC

~

Ganesh Acharya, MD PhD
Study Director
Karolinska Institute CLINTEC

Karolinska Institutet
Swiss National Science Foundation
NCT Number
MeSH Terms
Depression