1270 Participants Needed

Peer Support Programs for Perinatal Anxiety and Postpartum Depression

(Pathways Trial)

RG
CF
Overseen ByCarolyn Friedhoff, M.Bioethics
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NB

Nancy Byatt, DO, MS, MBA

Principal Investigator

UMass Chan Medical School and UMass Memorial Health

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced mental health conditions during pregnancy or up to one year postpartum. Participants must speak English, have received care at a partnering setting during the study period, and be involved in perinatal care as professionals.

Inclusion Criteria

Perinatal care setting team members: Provide verbal consent prior to the focus group or interview
I am fluent in English.
I have completed PSI training to be a peer mentor.
See 9 more

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of either the healthcare system-focused approach or the healthcare-community partnership approach, including screening, assessment, and treatment of mood and anxiety disorders

13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up for mental health concerns

3 months

Evaluation and Adaptation

Evaluation of the effectiveness of the approaches and adaptation for wider implementation, including meetings with advisory councils and stakeholders

Up to 2 years post-implementation

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two models of mental health care: a healthcare system approach versus a healthcare-community partnership model. It aims to determine which method should receive resources for improving perinatal mental health.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Healthcare system approachActive Control1 Intervention
Group II: Healthcare-Community Partnership approachActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+