Perinatal AnxietyPathwaysNCT06790641
Pathways to Perinatal Mental Health Equity
A study testing Program in Support of Moms (PRISM) and PSI Peer Support in people with Perinatal Anxiety and Perinatal Depression, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perinatal Anxiety, Perinatal Depression, Social Determinants of Health (SDOH)
- What is being tested?
- Program in Support of Moms (PRISM) and PSI Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,270 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 1 Oct 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Have completed PSI training to be a peer mentor
- Be 18 years of age or older
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Chan Medical School
Shrewsbury, Massachusetts, 01545
Carolyn M Friedhoff, MBE, 3059726131, carolyn.friedhoff@umassmed.edu
Padma Sankaran, MA, 5085613731, Padma.Sankaran@umassmed.edu
About this study
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.
Read the 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)
- Being tested
- Program in Support of Moms (PRISM), PSI Peer Support
- Keywords
- implementation strategies, obstetric care, perinatal mental health, perinatal anxiety, perinatal depression, perinatal mood disorders, qualitative study, focus groups, mixed methods, perinatal care, peer mentors, peer support, healthcare-community partnership
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program in Support of Moms (PRISM)Behavioural
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 SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare-Community Partnership approach | Active comparator | The Healthcare-Community Partnership approach will include the PRISM model plus PSI Peer Support specialists. Receives: Behavioral: Program in Support of Moms (PRISM); Behavioral: PSI Peer Support |
| Healthcare system approach | Active comparator | The Healthcare system approach will include the PRogram In Support of Moms (PRISM) model alone. Receives: Behavioral: Program in Support of Moms (PRISM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perinatal individual depression symptoms as measured by Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9)
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.
Measured: Baseline to up to 13 months postpartum
Secondary outcomes (2)
Change in perinatal individual anxiety symptoms as measured by Generalized Anxiety Disorder Scale (GAD-7)
Perinatal individual anxiety symptoms will be determined from their medical charts, through results of the Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 has seven items assessing anxiety severity and is validated in perinatal populations.
Measured: Baseline to up to 13 months postpartum
Proportion of perinatal individuals with evidence of initiation of treatment/support in their medical chart
Perinatal individual initiation of treatment/support will be determined by their medical charts' indication that they have received treatment or support. Treatment or support is defined as one initial mental health assessment or treatment visit, peer support encounter, or currently on medication for depression or anxiety. Perinatal individuals will receive a score of 1 if they initiated treatment or support or a score of 0 if they did not initiate treatment or support. This outcome refers to the percentage of perinatal individuals who received treatment or support.
Measured: Baseline to up to 13 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start5 Dec 2025
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized design. Interventions will be implemented at level of clinical settings and all patients at the setting will be eligible to receive intervention.
- Masking
- None (open label)
- Enrolment
- 1,270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Nancy Byatt, University of Massachusetts, Worcester
- Investigators
- Nancy Byatt, DO, MS, MBA, Principal investigator, UMass Chan Medical School and UMass Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790641
- Sponsor's protocol ID
- STUDY00001751
- Acronym
- Pathways
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No