P-POD for Postpartum Anxiety

(P-POD Trial)

Overseen By Michelle Roley Roberts, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Disqualifiers: Non-English speakers

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program designed to help prevent anxiety and OCD (Obsessive-Compulsive Disorder) in new mothers. It targets pregnant women entering their second trimester, particularly those in West Virginia at risk for postpartum anxiety. Participants will either engage in the Preventing Postpartum Onset Distress (P-POD) program or a general anxiety education program. Couples will complete online modules, and women will receive weekly phone support to aid their understanding and completion of the program. The trial seeks pregnant women in a romantic relationship whose partners are also willing to participate. As an unphased trial, this study offers a unique opportunity to contribute to research that could benefit future mothers facing similar challenges.

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 doctor.

What prior data suggests that the P-POD program is safe for postpartum women?

Research has shown that the Preventing Postpartum Onset Distress (P-POD) program is an online tool designed to reduce anxiety in new mothers. While specific studies on the safety of the P-POD program are not available, online programs like this typically focus on education and support rather than medication, which generally results in fewer safety concerns compared to drug-based treatments.

Similar online programs have been safely used to address mood and anxiety. These programs often include self-guided learning and coaching calls, which participants usually find manageable. As P-POD is still under research, further studies will help confirm its safety and effectiveness. However, as an educational program, it is unlikely to pose significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the P-POD program because it offers a unique approach to managing postpartum anxiety by being an online, self-guided tool, which makes it more accessible for new mothers, especially those in rural areas like West Virginia. Unlike traditional therapies that often require in-person sessions, this program can be accessed from home, providing flexibility and convenience for busy new parents. Additionally, P-POD is specifically designed to prevent anxiety before it becomes severe, offering a proactive rather than reactive solution. This innovative approach could significantly improve mental health support for postpartum women, addressing a critical gap in current treatment methods.

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

Studies have shown that the Preventing Postpartum Onset Distress (P-POD) program, which participants in this trial may receive, effectively reduces anxiety and obsessive-compulsive disorder (OCD) symptoms after childbirth. Initial findings suggest that offering these interventions online is practical and well-received by new mothers. Research indicates that technology-based programs like P-POD help manage anxiety and depression symptoms after having a baby. This approach provides an easy way for women at risk to get support and possibly prevent severe anxiety. Early data supports its potential to improve mental health for new mothers. Meanwhile, the Anxiety Education (ANX-ED) program, another treatment arm in this trial, serves as an attention control and adapts from an established in-person anxiety education condition. ^{1 5 6 7 8}

Who Is on the Research Team?

Michelle Roley Roberts, PhD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for women in West Virginia at risk of postpartum anxiety or OCD, starting their second trimester. Their partners can also participate. Women must have internet access and be willing to complete online modules and weekly coaching calls.

Inclusion Criteria

I am pregnant and in my second trimester.

In a romantic relationship

State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139

Exclusion Criteria

Must speak English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants work through the P-POD or ANX-ED modules, with weekly coaching calls for women

10 weeks

Weekly phone calls

Post-intervention Assessment

Women complete the post-intervention assessment, same measures as pre-assessment

1 week

Follow-up

Participants are monitored for changes in anxiety symptoms, relationships, and other outcomes at 8-weeks postpartum

8 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Anxiety Education (ANX-ED)
• Preventing Postpartum Onset Distress (P-POD)

Trial Overview The study compares P-POD, an online program aiming to reduce perinatal anxiety, with ANX-ED, an educational control intervention. Participants will engage with the content over ten weeks and assess its impact on anxiety symptoms and relationships postpartum.

How Is the Trial Designed?

Group I: Preventing Postpartum Onset Distress (P-POD) Experimental Treatment 1 Intervention

P-POD is an online self-guided program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia.

Group II: Anxiety Education (ANX-ED) Placebo Group 1 Intervention

ANX-ED will be adapted from an already-established in-person anxiety education control condition and will be modified to an Internet-based, self-guided program that serves as an attention control to P-POD.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07071025

Preventing Perinatal Anxiety: Testing an Internet-delivered ... The purpose of this study is to evaluate the Internet-delivered postpartum anxiety and obsessive-compulsive disorder (OCD) prevention program, called " ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39814512/

Preventing Postpartum Anxiety and Obsessive-Compulsive ... In the current study, we tested the feasibility, acceptability, and initial efficacy of an Internet-delivered postpartum anxiety and OCD prevention program.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03563339

Internet-delivered Postpartum Anxiety Prevention ... Left untreated, perinatal anxiety and OCD are associated with numerous adverse outcomes, such as maternal depression, preterm birth, impaired fetal development, ...

4. psychiatrist.com psychiatrist.com/jcp/immediate-postpartum-anxiety-association-with-postpartum-depression-case-control-study/

Determinants of Immediate Postpartum Anxiety and Its ... Results: The prevalence of IPPA in this population was 24%, and 7.4% for severe anxiety. Factors independently associated with IPPA were found.

5. jmir.org jmir.org/2024/1/e53236/

Investigating the Effectiveness of Technology-Based Distal ... Conclusions: Technology-based distal interventions are effective in reducing symptoms of postpartum depression and anxiety in birth mothers. Key ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK519070/

Perinatal Depression - StatPearls - NCBI Bookshelf The symptoms of postpartum blues are similar to perinatal depression, including crying, dysphoric affect, irritability, anxiety, insomnia, and appetite changes.

7. withpower.com withpower.com/trial/phase-puerperal-disorders-7-2025-55f56

P-POD for Postpartum Anxiety · Info for Participants The overarching goal of this study is to conduct a randomized control trial of P-POD, an online program designed to reduce and prevent perinatal anxiety in at- ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0146000524000788

Preventive interventions for perinatal mood and anxiety ... We review here the protocols and clinical trial data of four preventive counseling interventions that are effective at preventing PMADs.