PEN-3 Intervention for Postpartum Depression

Overseen By Mary Shaw, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Jackson State University

Disqualifiers: Low risk pregnancy, Non-resident, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve postpartum care for women in the Mississippi Delta by reducing maternal health issues and addressing racial and economic disparities. It will test the PEN-3 Intervention Model, a community-focused approach designed to enhance communication and trust between mothers and healthcare providers. Women who have had a high-risk pregnancy and live in Washington, Bolivar, Scott, Humphreys, or Carroll counties are well-suited for this study. The trial seeks to foster better healthcare outcomes by involving families and communities in the process. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could significantly enhance postpartum care in their communities.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the PEN-3 Intervention Model is safe for postpartum women?

Research has shown that the PEN-3 Intervention Model improves health by focusing on community and cultural factors. Although specific safety data from past studies on the PEN-3 model is not available, its emphasis on communication and community involvement suggests it is likely safe.

This trial is labeled as "Not Applicable" in terms of its phase, indicating it aims to understand and improve community practices rather than test a new drug or medical procedure. Therefore, it does not present direct safety concerns like those in drug trials.

Overall, the PEN-3 model focuses on enhancing healthcare relationships and trust, which typically does not involve physical risks. Participants can expect an emphasis on social and cultural strategies instead of medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEN-3 Intervention Model for postpartum depression because it takes a unique approach by focusing on sociocultural factors. Unlike traditional treatments, which often involve medication like antidepressants or psychotherapy, the PEN-3 Model assesses and enhances patient-clinical connections through cultural lenses to support positive maternal health outcomes. This personalized, culturally-informed method has the potential to offer more tailored support for mothers, addressing the root causes of depression that are tied to individual and community experiences.

What evidence suggests that the PEN-3 Intervention Model is effective for postpartum depression?

Research has shown that the PEN-3 Intervention Model, which participants in this trial will experience, improves communication and understanding about health, supporting better outcomes for mothers. This model uses a cultural approach to strengthen the connection between patients and doctors, crucial for addressing postpartum depression. One study found that women who received specific types of home visits felt significantly less depressed after three and six months. Telehealth, or online health services, has also proven effective in reducing depression and anxiety in new mothers. By focusing on community involvement and building trust, the PEN-3 Model aims to improve maternal health, especially for Black women and those living in the Mississippi Delta. ^{1 4 6 7 8}

Who Is on the Research Team?

Mary Shaw, PHD, M.ED

Principal Investigator

Jackson State University

Mary Shaw, PhD

Principal Investigator

Jackson State University

Are You a Good Fit for This Trial?

This trial is for high-risk pregnant women, specifically in Washington, Bolivar, Scott, Humphreys, and Carroll counties. It focuses on Black women and includes maternal community health leaders and healthcare providers from these areas.

Inclusion Criteria

My pregnancy is considered high risk.

I live in one of the target counties.

I am a maternal healthcare provider working in the specified areas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare

12 months

Minimally 2 postpartum clinic visits

Follow-up

Participants are monitored for improvements in trust, health literacy, engagement, and family support systems

12 months

What Are the Treatments Tested in This Trial?

Interventions

• The PEN-3 Intervention Model

Trial Overview The study tests the PEN-3 Intervention Model to improve trust and engagement in postpartum healthcare among women of the Mississippi Delta. It aims to reduce maternal mortality/morbidity and promote health equity through community partnership.

How Is the Trial Designed?

Group I: PEN-3 Assessment Model Experimental Treatment 1 Intervention

Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes

Who Is Running the Clinical Trial?

Jackson State University

Lead Sponsor

Trials

1

Recruited

250+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Mississippi State Department of Health

Collaborator

Trials

7

Recruited

1,600+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014592/

Proactive approaches to preventing postpartum depression ... The first RCT demonstrated that women receiving MB-based home visits had significant reductions in depressive symptoms at three and six months ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8532017/

Effectiveness of Telehealth Interventions for Women With ... The aim of this study is to evaluate the effectiveness of telehealth interventions in reducing depressive symptoms and anxiety in women with PPD.

4. withpower.com withpower.com/trial/phase-family-dynamics-2025-e47fc

PEN-3 Intervention for Postpartum Depression This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to ...

5. mental.jmir.org mental.jmir.org/2023/1/e39253/

The Efficacy of Be a Mom, a Web-Based Intervention to ... Results: Be a Mom was found to be effective in reducing depressive (intervention group: µΔ=–3.35; P<.001 vs control group: µΔ=–1.48; P<.001) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11230976/

Digital screening for mental health in pregnancy and ... Up to 20% of pregnant women are affected by mental health disorders such as depression and anxiety, during pregnancy or in the first year after giving birth ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04847076

Feasibility of M-health Version of "What Were We Thinking ... Finally, in the health check-ups at 2 and 6 months of age of the child, Edinburgh Postpartum Depression Scale is used for screening depressive symptoms in ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e103064

Mindfulness-based mHealth intervention for pregnant black ... This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based ( ...