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

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

Not yet recruiting
Perinatal Depression
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.

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
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Hong Kong

Shanghai Women's and Children's Health Center
Shanghai, Shanghai, China

Chinese University Hong Kong
Hong Kong, Hong Kong


Simone E Schwank, PhD

Ganesh Acharya, MD PhD
‭+46 70-099 63 35‬

Swiss National Science Foundation
NCT Number
MeSH Terms