Clinical trial NCT04363177: Global Mental Health of Urban Mothers
Official title: Mental Health of Urban Mothers (MUM) Study: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perinatal Depression
COVID19
Anxiety
PTSD
Pregnancy Related
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2020-04-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 4-6 weeks postpartum
Secondary outcomes:
measure: Mental health status and COVID-19
timeFrame: 4-6 weeks postpartum
measure: Socio-economic status (education level, income, marital status, profession, nationality)
timeFrame: 4-6 weeks postpartum
measure: Elective CS
timeFrame: 4-6 weeks postpartum
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Women's and Children's Health Center
state: Shanghai
city: Hong Kong
country: Hong Kong
facility: Chinese University Hong Kong
Study officials:
affiliation: Karolinska Institute CLINTEC
name: Simone E Schwank, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institute CLINTEC
name: Ganesh Acharya, MD PhD
role: STUDY_DIRECTOR
References:
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citation: Buss C, Davis EP, Hobel CJ, Sandman CA. Maternal pregnancy-specific anxiety is associated with child executive function at 6-9 years age. Stress. 2011 Nov;14(6):665-76. doi: 10.3109/10253890.2011.623250.
citation: Doyle C, Werner E, Feng T, Lee S, Altemus M, Isler JR, Monk C. Pregnancy distress gets under fetal skin: Maternal ambulatory assessment & sex differences in prenatal development. Dev Psychobiol. 2015 Jul;57(5):607-25. doi: 10.1002/dev.21317. Epub 2015 May 6.
citation: Liang H, Acharya G. Novel corona virus disease (COVID-19) in pregnancy: What clinical recommendations to follow? Acta Obstet Gynecol Scand. 2020 Apr;99(4):439-442. doi: 10.1111/aogs.13836. Epub 2020 Mar 5. No abstract available.
citation: Thapa SB, Mainali A, Schwank SE, Acharya G. Maternal mental health in the time of the COVID-19 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):817-818. doi: 10.1111/aogs.13894. No abstract available.
citation: Monk C, Feng T, Lee S, Krupska I, Champagne FA, Tycko B. Distress During Pregnancy: Epigenetic Regulation of Placenta Glucocorticoid-Related Genes and Fetal Neurobehavior. Am J Psychiatry. 2016 Jul 1;173(7):705-13. doi: 10.1176/appi.ajp.2015.15091171. Epub 2016 Mar 25.
citation: Brummelte S, Galea LA. Postpartum depression: Etiology, treatment and consequences for maternal care. Horm Behav. 2016 Jan;77:153-66. doi: 10.1016/j.yhbeh.2015.08.008. Epub 2015 Aug 28.
citation: Schwank SE, Chung HF, Hsu M, Fu SC, Du L, Zhu L, Huang HY, Andersson E, Acharya G. Mental health of Urban Mothers (MUM) study: a multicentre randomised controlled trial, study protocol. BMJ Open. 2020 Nov 27;10(11):e041133. doi: 10.1136/bmjopen-2020-041133.