Recruiting

Mental Health Care

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06790641

Conditions

Perinatal Anxiety

Perinatal Depression

Social Determinants of Health (SDOH)

Peer Support

Obstetric Care

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Program in Support of Moms (PRISM)

PSI Peer Support

Study Details

Brief 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.

Conditions

Perinatal Anxiety

Perinatal Depression

Social Determinants of Health (SDOH)

Peer Support

Obstetric Care

Study ID

NCT06790641

Start date

Dec 5, 2025

Status verified date

Apr, 2026

Completion date

Oct 1, 2030

Anticipated

Primary completion date

Oct 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Healthcare-Community Partnership approach

The Healthcare-Community Partnership approach will include the PRISM model plus PSI Peer Support specialists.

active comparator: Healthcare system approach

The Healthcare system approach will include the PRogram In Support of Moms (PRISM) model alone.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rebekah Getman, PhD

6177636460Rebekah.Getman2@umassmed.edu

Carolyn Friedhoff, M.Bioethics

3059726131carolyn.friedhoff@umassmed.edu

Locations

UMass Chan Medical School

Recruiting

Shrewsbury, Massachusetts, United States, 01545

Contacts

Carolyn M Friedhoff, MBE

3059726131carolyn.friedhoff@umassmed.edu

Padma Sankaran, MA

5085613731Padma.Sankaran@umassmed.edu

Principal Investigator:

Nancy Byatt, DO, MS, MBA, DFAPA, FACLP

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-04-20.