Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1270 participants
INTERVENTIONAL
2025-12-05
2030-10-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Healthcare-Community Partnership approach
The Healthcare-Community Partnership approach will include the PRISM model plus PSI Peer Support specialists.
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.
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.
Healthcare system approach
The Healthcare system approach will include the PRogram In Support of Moms (PRISM) model alone.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Be 18 years of age or older
* Provide verbal consent prior to the focus group or interview
* Be proficient in English
* Have completed PSI training to be a peer mentor
* Be 18 years of age or older
* Provide verbal consent prior to the focus group or interview
* Be proficient in English
* Have received perinatal care at a study partnering perinatal care setting during the study period
* Be 18 years of age or older
* Provide verbal consent prior to the focus group or interview
* Be proficient in English or Spanish
18 Years
70 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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Nancy Byatt
Principal Investigator
Principal Investigators
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Nancy Byatt, DO, MS, MBA
Role: PRINCIPAL_INVESTIGATOR
UMass Chan Medical School and UMass Memorial Health
Locations
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UMass Chan Medical School
Shrewsbury, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00001751
Identifier Type: -
Identifier Source: org_study_id
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