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Global Mental Health of Urban Mothers (MUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363177
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Simone Eliane, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Perinatal Depression COVID19 Anxiety PTSD Pregnancy Related Behavioral: Web-based psychosocial peer-to-peer support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Mental Health of Urban Mothers (MUM) Study: A Multi-center Randomized Controlled Trial
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Web-based psychosocial peer-to-peer support
Web-based psychosocial peer-to-peer support, using "Thinking Healthy" two times during pregnancy
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.

Active Comparator: Standard perinatal care
Perinatal standard care in Hong Kong, Shanghai
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.




Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 4-6 weeks postpartum ]

    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 :
  1. Mental health status and COVID-19 [ Time Frame: 4-6 weeks postpartum ]

    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


  2. Socio-economic status (education level, income, marital status, profession, nationality) [ Time Frame: 4-6 weeks postpartum ]

    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.


  3. Elective CS [ Time Frame: 4-6 weeks postpartum ]
    Relationship between mental health status of pregnant women and rates of elective cesarean section (CS) on maternal request.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363177


Contacts
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Contact: Simone E Schwank, PhD ‭+41796137255 simone.schwank@ki.se
Contact: Ganesh Acharya, MD PhD ‭+46 70-099 63 35‬ ganesh.acharya@ki.se

Locations
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China, Shanghai
Shanghai Women's and Children's Health Center
Shanghai, Shanghai, China
Contact: Liping Zhu, PhD       shzhuliping@163.com   
Contact    0086 021-32576339      
Hong Kong
Chinese University Hong Kong
Hong Kong, Hong Kong
Contact: Hsuan-Ying Huang, PhD    ‭+852 9137 8406‬    hsuan-ying.huang@cuhk.edu.hk   
Sponsors and Collaborators
Karolinska Institutet
Swiss National Science Foundation
Investigators
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Principal Investigator: Simone E Schwank, PhD Karolinska Institute CLINTEC
Study Director: Ganesh Acharya, MD PhD Karolinska Institute CLINTEC
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simone Eliane, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04363177    
Other Study ID Numbers: P2SKP3_187728
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms