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Global Mental Health of Urban Mothers (MUM)

Primary Purpose

Perinatal Depression, COVID19, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Web-based psychosocial peer-to-peer support
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Women's and Children's Health Center
  • Chinese University Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Web-based psychosocial peer-to-peer support

Standard perinatal care

Arm Description

Web-based psychosocial peer-to-peer support, using "Thinking Healthy" two times during pregnancy

Perinatal standard care in Hong Kong, Shanghai

Outcomes

Primary Outcome Measures

Edinburgh Postnatal Depression Scale (EPDS)
To investigate the impact of a web-based psychosocial intervention on Edinburgh Postnatal Depression Scale (EPDS) in urban women living in Hong Kong and Shanghainese women. Scores of EPDS range from min = 0 to max=30. The higher the score, the more depressed a woman is.

Secondary Outcome Measures

Mental health status and COVID-19
Correlation between mental health status (EPDS, GAD7, IES-R) and COVID-19 pandemic among pregnant women. GAD 7 Generalized anxiety questionnaire IES-R Impact Event Scale to assess Post traumatic stress Disorder (PTSD) COVID-19 questionnaire
Socio-economic status (education level, income, marital status, profession, nationality)
Impact of web-based psychosocial intervention on mental health and pregnancy outcomes among women from different socio-economic and cultural environments. Socio-economic information gained by sociodemographic questions.
Elective CS
Relationship between mental health status of pregnant women and rates of elective cesarean section (CS) on maternal request.

Full Information

First Posted
April 21, 2020
Last Updated
March 28, 2022
Sponsor
Karolinska Institutet
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04363177
Brief Title
Global Mental Health of Urban Mothers
Acronym
MUM
Official Title
Mental Health of Urban Mothers (MUM) Study: A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, COVID19, Anxiety, PTSD, Pregnancy Related

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Web-based psychosocial peer-to-peer support
Arm Type
Experimental
Arm Description
Web-based psychosocial peer-to-peer support, using "Thinking Healthy" two times during pregnancy
Arm Title
Standard perinatal care
Arm Type
Active Comparator
Arm Description
Perinatal standard care in Hong Kong, Shanghai
Intervention Type
Behavioral
Intervention Name(s)
Web-based psychosocial peer-to-peer support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
To investigate the impact of a web-based psychosocial intervention on Edinburgh Postnatal Depression Scale (EPDS) in urban women living in Hong Kong and Shanghainese women. Scores of EPDS range from min = 0 to max=30. The higher the score, the more depressed a woman is.
Time Frame
4-6 weeks postpartum
Secondary Outcome Measure Information:
Title
Mental health status and COVID-19
Description
Correlation between mental health status (EPDS, GAD7, IES-R) and COVID-19 pandemic among pregnant women. GAD 7 Generalized anxiety questionnaire IES-R Impact Event Scale to assess Post traumatic stress Disorder (PTSD) COVID-19 questionnaire
Time Frame
4-6 weeks postpartum
Title
Socio-economic status (education level, income, marital status, profession, nationality)
Description
Impact of web-based psychosocial intervention on mental health and pregnancy outcomes among women from different socio-economic and cultural environments. Socio-economic information gained by sociodemographic questions.
Time Frame
4-6 weeks postpartum
Title
Elective CS
Description
Relationship between mental health status of pregnant women and rates of elective cesarean section (CS) on maternal request.
Time Frame
4-6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simone E Schwank, PhD
Phone
‭+41796137255
Email
simone.schwank@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ganesh Acharya, MD PhD
Phone
‭+46 70-099 63 35‬
Email
ganesh.acharya@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone E Schwank, PhD
Organizational Affiliation
Karolinska Institute CLINTEC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ganesh Acharya, MD PhD
Organizational Affiliation
Karolinska Institute CLINTEC
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Women's and Children's Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Zhu, PhD
Email
shzhuliping@163.com
Phone
0086 021-32576339
Facility Name
Chinese University Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsuan-Ying Huang, PhD
Phone
‭+852 9137 8406‬
Email
hsuan-ying.huang@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16891597
Citation
Brand SR, Engel SM, Canfield RL, Yehuda R. The effect of maternal PTSD following in utero trauma exposure on behavior and temperament in the 9-month-old infant. Ann N Y Acad Sci. 2006 Jul;1071:454-8. doi: 10.1196/annals.1364.041.
Results Reference
background
PubMed Identifier
21995526
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.
Results Reference
background
PubMed Identifier
25945698
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.
Results Reference
background
PubMed Identifier
32141062
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.
Results Reference
background
PubMed Identifier
32374420
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.
Results Reference
background
PubMed Identifier
27013342
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.
Results Reference
background
PubMed Identifier
26319224
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.
Results Reference
background
PubMed Identifier
33247023
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.
Results Reference
derived

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Global Mental Health of Urban Mothers

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