Clinical trial NCT06790641: Pathways to Perinatal Mental Health Equity
Official title: Pathways to Perinatal Mental Health Equity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Anxiety
Perinatal Depression
Social Determinants of Health (SDOH)
Peer Support
Obstetric Care
Substance Use Disorder (SUD)
Perinatal Depression, Substance Use
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
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2025-01-24
Enrollment: 1270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in depression score as measured by either Edinburg Postnatal Depression Scale (EPDS) or Patient Health Questionnaire (PHQ9)
timeFrame: Baseline to up to 13 months postpartum
measure: Proportion of perinatal individuals with evidence of initiation of treatment/support in their medical chart
timeFrame: Baseline to up to 13 months postpartum
Secondary outcomes:
measure: Perinatal individual anxiety symptoms
timeFrame: Baseline to up to 13 months postpartum
Other outcomes:
measure: Perinatal individual screening, assessment, treatment, and follow-up
timeFrame: Baseline to up to 13 months postpartum
measure: Perinatal Individuals Social Determinants of Health (SDOH) screening and referral
timeFrame: Baseline to up to 13 months postpartum
measure: Workforce capacity and support for engaging in mental health care
timeFrame: Baseline to up to 2 years post-implementation
Locations:
Study officials:
affiliation: UMass Chan Medical School and UMass Memorial Health
name: Nancy Byatt, DO, MS, MBA
role: PRINCIPAL_INVESTIGATOR
References: