Global Mental Health of Urban Mothers

NCT ID: NCT04363177

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-12-31

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.

Conditions

Perinatal Depression; COVID19; Anxiety; PTSD; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Web-based psychosocial peer-to-peer support

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

Group Type: EXPERIMENTAL

Web-based psychosocial peer-to-peer support

Intervention Type: 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

Perinatal standard care in Hong Kong, Shanghai

Group Type: ACTIVE_COMPARATOR

Web-based psychosocial peer-to-peer support

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Simone Eliane

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone E Schwank, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute CLINTEC

Ganesh Acharya, MD PhD

Role: STUDY_DIRECTOR

Karolinska Institute CLINTEC

Locations

Shanghai Women's and Children's Health Center

Shanghai, Shanghai Municipality, China

Chinese University Hong Kong

Hong Kong, , Hong Kong

Countries

China; Hong Kong

Central Contacts

Simone E Schwank, PhD

Role: CONTACT

simone.schwank@ki.se

‭+41796137255

Ganesh Acharya, MD PhD

Role: CONTACT

ganesh.acharya@ki.se

‭+46 70-099 63 35‬

Facility Contacts

Liping Zhu, PhD

Role: primary

shzhuliping@163.com

Role: backup

0086 021-32576339

Hsuan-Ying Huang, PhD

Role: primary

hsuan-ying.huang@cuhk.edu.hk

‭+852 9137 8406‬

References

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.

Reference Type: BACKGROUND

PMID: 16891597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21995526 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25945698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32141062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32374420 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27013342 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26319224 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33247023 (View on PubMed)

Other Identifiers

P2SKP3_187728

Identifier Type: -

Identifier Source: org_study_id