Global Mental Health of Urban Mothers

NCT04363177 | Unknown DMC

• 1 other identifier: P2SKP3_187728
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

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.

Conditions

Perinatal Depression; COVID19; Anxiety; PTSD; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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.

  4-6 weeks postpartum

Secondary Outcomes (3)

• Mental health status and COVID-19

  4-6 weeks postpartum

• Socio-economic status (education level, income, marital status, profession, nationality)

  4-6 weeks postpartum

• Elective CS

  4-6 weeks postpartum

Study Arms (2)

Web-based psychosocial peer-to-peer support

EXPERIMENTAL

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

Behavioral: Web-based psychosocial peer-to-peer support

Standard perinatal care

ACTIVE COMPARATOR

Perinatal standard care in Hong Kong, Shanghai

Behavioral: Web-based psychosocial peer-to-peer support

Interventions

Web-based psychosocial peer-to-peer support BEHAVIORAL

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

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women between 12 and 18 weeks of gestation
• Viable intrauterine pregnancy.

You may not qualify if:

• History of severe psychiatric
• Substance abuse disorder
• Requiring medical treatment
• Presence of fetal chromosomal/structural abnormality

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swiss National Science Foundation: collaborator

Study Sites (2)

Shanghai Women's and Children's Health Center

Shanghai, Shanghai Municipality, China

Location

Chinese University Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (8)

• 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.

  PMID: 16891597 BACKGROUND

• 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.

  PMID: 21995526 BACKGROUND

• 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.

  PMID: 25945698 BACKGROUND

• 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.

  PMID: 32141062 BACKGROUND

• 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.

  PMID: 32374420 BACKGROUND

• 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.

  PMID: 27013342 BACKGROUND

• 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.

  PMID: 26319224 BACKGROUND

• 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.

  PMID: 33247023 DERIVED

MeSH Terms

Conditions

COVID-19; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Simone E Schwank, PhD

  Karolinska Institute CLINTEC

  PRINCIPAL INVESTIGATOR

• Ganesh Acharya, MD PhD

  Karolinska Institute CLINTEC

  STUDY DIRECTOR

Central Study Contacts

Simone E Schwank, PhD

CONTACT

‭+41796137255; simone.schwank@ki.se

Ganesh Acharya, MD PhD

CONTACT

‭+46 70-099 63 35‬; ganesh.acharya@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 27, 2020
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); CN (1)