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?

This trial tests two methods to support mental health for individuals experiencing anxiety or depression during pregnancy and up to a year postpartum. One group will use a healthcare system model called Program in Support of Moms (PRISM), while the other will use PRISM plus support from community specialists. The researchers aim to determine which approach better improves mental health care access for pregnant and postpartum individuals. The trial seeks participants who have received care at one of the study's partner clinics and can communicate in English or Spanish. As an unphased trial, it offers a unique opportunity to contribute to enhancing mental health support for new and expecting mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mental health support rather than medication changes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Program in Support of Moms (PRISM) and PSI Peer Support have been well-received by participants. PRISM has effectively treated depression during and after pregnancy in various settings. Past studies reported that participants handled it well, with no major safety issues. It offers quick access to helpful resources and referrals.

Similarly, PSI Peer Support has shown positive results. Studies have found that peer support can reduce symptoms of depression after childbirth. Participants in earlier research also found it safe, with no significant negative effects.

In summary, both PRISM and PSI Peer Support have been studied and are considered safe for participants. They aim to provide support and improve mental health during and after pregnancy without serious side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for Peer Support Programs for Perinatal Anxiety and Postpartum Depression because it explores innovative approaches to mental health care. Unlike traditional treatments like medication and therapy, this trial investigates peer support systems, which can offer a more personal and relatable form of assistance. The PRISM model focuses on healthcare professionals providing support, while the PSI Peer Support approach includes community members who have shared experiences. This combination might offer more comprehensive care by integrating professional guidance with empathetic peer support, potentially leading to better outcomes for new moms.

What evidence suggests that this trial's treatments could be effective for perinatal anxiety and postpartum depression?

Research has shown that the Program in Support of Moms (PRISM), available to participants in this trial, effectively reduces depression symptoms in pregnant and new mothers. One study found that PRISM decreased both the severity of depression and the number of women with high depression scores. Another treatment option in this trial is the Healthcare-Community Partnership approach, which includes PSI Peer Support specialists. Studies indicate that peer support can lessen the severity and occurrence of postpartum depression. This method involves receiving help from others who have faced similar challenges, which can be very beneficial. Both treatments in this trial aim to improve mental health during pregnancy and after childbirth by providing specific support and resources.12467

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?

Interventions

  • Program in Support of Moms (PRISM)
  • PSI Peer Support

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+

Citations

The Effect of Peers Support on Postpartum Depression - PMC

Introduction: Postpartum depression and its consequences not only involve mothers and their children but it will also affect their families.

Essential Reads: Peer Support Interventions for Perinatal ...

Peer support interventions can reduce the incidence of postpartum depression and the severity of depressive symptoms.

Review article Effectiveness of psychological interventions ...

Women with depression during pregnancy are at increased risk of experiencing postpartum psychiatric disorders (Robertson et al., 2004) and ...

Evaluation of a Technology-Based Peer-Support ...

them susceptible to postpartum psychological disorders such as postnatal depression (PND). Social support has been found to be effective in ...

5.

samhsa.gov

samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ...

SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

NCT06790641 | Pathways to Perinatal Mental Health Equity

In response, the study team has developed approaches for addressing mood and anxiety disorders in both healthcare and community settings caring for pregnant and ...

Current Research Announcements

We aim to connect individuals with researchers working to better understand perinatal mental health and improve care.