NCT06790641

Pathways to Perinatal Mental Health Equity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,270 (estimated)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, "Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.

Detailed description

Mental health conditions are now the leading cause of death during pregnancy and the postpartum period (the perinatal period) in the United States. One in five individuals who are pregnant or one year or less postpartum experience a mood or anxiety disorder. Despite these risks and the availability of evidence-based treatments for mood and anxiety disorders that occur during this time, most do not receive adequate treatment, if any at all. Gaps in care loom largest for individuals who are Black or African American, Hispanic or Latino, American Indian or Alaska Native, or Native Hawaiian or other Pacific Islander. Thus, it is recommended that, in order to detect and address perinatal mood and anxiety disorders and related social inequities, screening be implemented in both healthcare and community settings. In response, the study team has developed approaches for addressing mood and anxiety disorders in both healthcare and community settings caring for pregnant and postpartum individuals. These programs have been adopted across the United States. The study's community partner, Postpartum Support International (PSI), developed a national Peer Support Program that pairs individuals in need of support with a trained volunteer who has also experienced and fully recovered from a perinatal mood and anxiety disorder. The study's research partner, UMass Chan, developed: * A statewide program that offers support to patients and their medical professionals to help them both address mental health during pregnancy and the postpartum period. * A national network of similar statewide programs to coordinate their efforts across the United States. * A comprehensive approach to help obstetric care settings address mental health concerns among their patients. Despite the benefits of these programs, investigators have learned that none of them is sufficient to address mental health challenges on their own. In response, investigators will conduct this study to examine what happens when healthcare- and community-based teams' partner to deliver care for perinatal mood and anxiety disorders. One of the aims of the study is to test the effectiveness of the Healthcare-Community Partnership between PSI and UMass Chan. Thirty-two perinatal care settings (e.g., clinics, practices, and health centers providing care to pregnant and postpartum individuals) across the United States will implement either a 1) health system-focused approach or 2) healthcare-community partnership approach to mental health. In the health system-focused approach, perinatal care settings will integrate screening, assessment, and treatment of mood and anxiety disorders into prenatal and postpartum care. The Healthcare-Community Partnership approach will include the health system-focused approach and PSI Peer Support. Thus, all patients getting perinatal care at the 32 clinical sites will be offered the intervention. The study team will then look at patient charts to see if patients receive treatment and/or peer support and whether depression and anxiety symptoms improve. Researchers will also look at how well perinatal care settings implement mental health care such as screening for depression, anxiety and social determinants of health; how often they identify patient needs; and how often they help patients find services to address those needs. The study team will also conduct surveys to look at racial bias and discrimination and burnout among the perinatal care professionals and peer mentors who are delivering the approaches. Another aim is to prepare to spread what the study team learns to other perinatal care settings. Having learned that even proven approaches sometimes need to be adapted to make them work in new settings with new groups of people, the study team will meet and talk with patients, perinatal care professionals, and peer mentors who participate in the study to learn about their experiences. The study's goal is to identify barriers and facilitators to using these approaches on a wider scale. The researcher-community partnership is led by PSI, a community-based organization promoting mental health awareness, support, and treatment for pregnant and postpartum individuals worldwide, and UMass Chan Medical School. The team includes experts in their own lived experience, psychiatry, psychology, obstetrics, health equity, public health, advocacy, statistics, social work and health services research. The research team will also work with a network of programs across the United States that aim to increase access to mental health care for pregnant and postpartum individuals. To amplify the voices of individuals central to the study, researchers will also partner with the study's three advisory councils. The first council includes individuals with lived experience of mental health challenges and oppression. The second council includes the professionals and providers serving these populations. The third council involves members of teams working to increase access to mental health care. The study team will meet with the advisory councils every other month to discuss its approaches, study procedures and findings.

Conditions

• Perinatal Anxiety
• Perinatal Depression
• Social Determinants of Health (SDOH)
• Peer Support
• Obstetric Care
• Substance Use Disorder (SUD)
• Perinatal Depression, Substance Use

Interventions

Type	Name	Description
BEHAVIORAL	Program in Support of Moms (PRISM)	Program in Support of Moms (PRISM): a practice-level intervention with implementation support that helps obstetric practices integrate mental health care for perinatal individuals. To help obstetric practices implement pathways for screening, assessment, and a stepped intervention response for mental health problems and social determinants of health. PRISM offers training in trauma informed and equitable care, technical assistance, and implementation and change management support.
BEHAVIORAL	PSI Peer Support	Postpartum Support International (PSI) Peer Support: a service administered by PSI that pairs perinatal individuals with a volunteer peer mentor who provides support, psychoeducation, behavioral activation, and navigation services, which includes planning, goal setting, and practical tools to manage parenting and mental health symptoms.

Timeline

• Start date: 2025-12-05
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2025-01-24
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States