NCT06790641 · University of Massachusetts, Worcester
Pathways to Perinatal Mental Health Equity
(Pathways)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Change in perinatal individual depression symptoms as measured by Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9)
Time frame: Baseline to up to 13 months postpartum
Perinatal individual depressive symptoms will be determined from their medical charts, through the screening questionnaire used by their care setting. The screener may be the Edinburgh Postnatal Depression Scale (EPDS) or the Patient Health Questionnaire-9 (PHQ-9). The 10-item EPDS is the most widely used measure of perinatal depression symptoms. The 9-item PHQ-9 is the most widely-used measure of depression symptoms across the lifespan and the second most widely used measure during the perinatal period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for perinatal care setting team members:
- Be employed by a participating perinatal care setting in a clinical role (including as an obstetrician-gynecologist, midwife, nurse practitioner, a nurse, a navigator, or administrative staff member who implemented the respective intervention 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 Inclusion Criteria for peer mentors:
- 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 Inclusion Criteria for perinatal individuals:
- 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
Exclusion criteria
- An individual who does not meet the inclusion criteria listed above will be excluded from participation in this study. There are no additional exclusion criteria.
Where
- Shrewsbury, Massachusetts
Collaborators
Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations