Pathways to Perinatal Mental Health Equity

NCT06790641 | Recruiting DMC

• 1 other identifier: STUDY00001751
• Study Type: interventional
• Target: 1,270
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline to up to 13 months postpartum

• Proportion of perinatal individuals with evidence of initiation of treatment/support in their medical chart

  Baseline to up to 13 months postpartum

Other Outcomes (3)

• Perinatal individual screening, assessment, treatment, and follow-up

  Baseline to up to 13 months postpartum

• Perinatal Individuals Social Determinants of Health (SDOH) screening and referral

  Baseline to up to 13 months postpartum

• Workforce capacity and support for engaging in mental health care

  Baseline to up to 2 years post-implementation

Study Arms (2)

Healthcare-Community Partnership approach

ACTIVE COMPARATOR

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

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.

Behavioral: Program in Support of Moms (PRISM)

Interventions

PSI Peer Support BEHAVIORAL

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-Community Partnership approach

Program in Support of Moms (PRISM) BEHAVIORAL

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.

Healthcare system approach; Healthcare-Community Partnership approach

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

UMass Chan Medical School

Shrewsbury, Massachusetts, 01545, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Nancy Byatt, DO, MS, MBA

  UMass Chan Medical School and UMass Memorial Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebekah Getman, PhD

CONTACT

6177636460; Rebekah.Getman2@umassmed.edu

Carolyn Friedhoff, M.Bioethics

CONTACT

3059726131; carolyn.friedhoff@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster randomized design. Interventions will be implemented at level of clinical settings and all patients at the setting will be eligible to receive intervention.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 24, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)