Virtual Navigator Program for Postpartum Depression

Overseen By Michelle Reece, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Suicidality, Severe depression, Child maltreatment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a virtual program can improve access to mental health care for women with postpartum depression. Researchers aim to identify factors that facilitate or hinder the use of virtual mental health services and adapt a support program accordingly. Women with persistent symptoms of postpartum depression who are not currently using mental health services may be suitable candidates. Participants will engage in interviews or join the Virtual Navigator Program, a digital health support program, over two months to test its effectiveness. As an unphased trial, this study provides a unique opportunity for participants to contribute to the development of innovative mental health solutions.

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 might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Virtual Navigator Program is safe for postpartum women?

Research has shown that digital and virtual guidance programs are generally safe and well-liked. For example, studies on similar programs have found that they help women stay involved in postpartum care and can even boost mental health.

While specific safety data for the Virtual Navigator Program is not available, similar programs have not reported major negative effects. This suggests the program is likely safe and easy to handle. Users of these programs often find them helpful and simple to use, indicating their overall safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Navigator Program for postpartum depression because it harnesses the power of virtual technology to make mental health support more accessible. Unlike traditional in-person therapy sessions, which can be difficult to attend due to logistical challenges like childcare and transportation, this program offers a convenient and flexible online format. Additionally, by using rapid cycle testing, it allows for continuous adaptation and improvement, ensuring that the intervention is tailored to meet the unique needs of each participant in real-time. This innovative approach has the potential to break down barriers to care and provide timely support to new mothers dealing with postpartum depression.

What evidence suggests that the Virtual Navigator Program is effective for postpartum depression?

Research has shown that programs with patient navigators can help people access care for postpartum depression. One study found that women in a postpartum navigation program attended follow-up doctor visits more often than those not in the program. This finding suggests that a dedicated navigator can help overcome obstacles to care. In this trial, participants in the intervention phase will engage with the Virtual Navigator Program, which aims to simplify the healthcare system, making it easier for patients to receive the help they need. These programs guide and support patients, which is especially important for those dealing with mental health issues like postpartum depression. ^{1 6 7 8 9}

Who Is on the Research Team?

James Guevara, MD, MPH

Principal Investigator

Children's Hospital of Philadelphia

Rhonda C. Boyd, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for women experiencing persistent postpartum depression symptoms. The study aims to understand and improve access to virtual mental health services for these individuals.

Inclusion Criteria

Women who have access to a smart phone or computer tablet with internet access

Women who are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT

I am a woman aged 18 or older.

Exclusion Criteria

I am currently receiving mental health services.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Phase

Participants engage in semi-structured interviews to identify barriers and facilitators to accessing virtual mental health services

1-2 weeks

1 visit (virtual or in-person)

Intervention Phase

Participants receive the adapted virtual navigator program using rapid cycle testing over a 2-month period

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for depressive symptoms and suicidality monthly

2 months

Monthly virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Navigator Program

Trial Overview The trial is testing an adapted virtual navigator program designed to help women with postpartum depression. It includes interviews to identify barriers and facilitators, followed by a test of the navigation service over two months.

How Is the Trial Designed?

Group I: Intervention Phase Experimental Treatment 1 Intervention

For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.

Group II: Qualitative phase Active Control 1 Intervention

The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services during the pandemic. This information will be used to adapt an evidence-based patient navigation intervention for virtual use.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Women are at a higher risk for perinatal mood and anxiety disorders (PMADs) during the perinatal period, and many do not receive the necessary mental health care despite the availability of effective treatments.

The development of a patient navigation (PN) service in an intensive outpatient program has shown promise in improving treatment attendance and engagement for women with PMADs, suggesting that this model could be beneficial for other care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stepped Care Model of Patient Navigation to Enhance Engagement with Perinatal Mental Health Care. DiSanza, CB., Geller, PA., Bonacquisti, A., et al.[2020]

Only 64% of primary maternal and child health workers in Hunan Province were able to accurately diagnose postpartum depression, indicating a need for improved training and resources.

The study found that treatment accuracy was even lower at 50.9%, with workers from more economically developed areas showing better treatment capabilities, highlighting the influence of regional economic factors on healthcare competency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual patient to assess primary health workers' competence to detect postpartum depression in Hunan, China. Zhang, C., Jin, X., Luo, D., et al.[2022]

Postpartum patient navigation significantly improves attendance at postpartum visits for low-income women, especially those with antenatal depressive symptoms, as shown in a study of 474 women.

In the navigation cohort, the presence of antenatal depressive symptoms did not affect attendance, indicating that patient navigation effectively mitigates this risk factor for nonattendance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Postpartum Patient Navigation Uniquely Beneficial for Women with Antenatal Depressive Symptoms? Martinez, NG., Yee, LM., Miller, ES.[2022]

Patient-reported outcomes (PROs) are increasingly recognized as valuable data for evaluating product safety, effectiveness, and quality of care, reflecting a shift towards more patient-centered healthcare practices.

Integrating PROs into electronic health records and patient portals can improve care delivery and communication, although challenges such as implementation costs and data standardization need to be addressed for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. Basch, E.[2014]

Implementing best practices in clinical care is crucial for improving patient outcomes, highlighting the importance of understanding this connection.

As outcomes-driven measures like OBQI become more prevalent, healthcare providers must adapt their clinical interventions to align with these quality standards for better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standards of care and best practices: the link to patient outcomes. Huffman, MH.[2019]

Patient-reported outcomes (PROs) provide valuable insights directly from patients about their health conditions, but their role in guiding healthcare decisions is not yet fully understood.

The review highlights challenges in implementing PROs in clinical settings and proposes an evidence-based framework to enhance their use, along with future developments like individualized measurement and computer-adaptive testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities. Porter, I., Gonçalves-Bradley, D., Ricci-Cabello, I., et al.[2022]

A survey of 794 care team members revealed that while 96.7% have a protocol for screening peripartum depression (PPD), only 69.6% routinely screen all pregnant patients, indicating a gap in consistent screening practices.

Despite high self-reported rates of screening and training, 96.5% of respondents believe their organizations would benefit from additional training, suggesting that current efforts may not be sufficient to address the ongoing risks of maternal suicide and poor mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving maternal mental health: assessing the extent of screening and training about peripartum depression. Valdes, EG., Sparkman, L., Aamar, R., et al.[2023]

The postpartum period is crucial for improving maternal health, but many individuals face barriers to effective care, leading to poor health outcomes; patient navigation is a promising intervention to help overcome these obstacles.

A comprehensive training guide for postpartum patient navigators was developed, emphasizing six core elements essential for effective navigation, which can be adapted for various healthcare settings to enhance postpartum care access and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Yee, LM., Williams, B., Green, HM., et al.[2023]

Patient-reported outcome measures (PROM) are effective tools for assessing treatment outcomes, focusing on improving patients' functional, cognitive, and mental states, as well as their overall quality of life.

Despite the benefits of integrating electronic PROM into clinical practice, barriers such as financial, personnel, and technical challenges hinder their widespread adoption, which is necessary for enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient reported outcome measures in public reporting : Objectification of quality information via physicians and hospitals]. Eberle, KR., Schlagbauer, K.[2020]

Patient-centered outcome measurement is crucial for assessing the quality, effectiveness, and value of care in the evolving US healthcare system, emphasizing the importance of understanding disease impact.

The paper highlights how using outcome measurement tools in neurosurgery can enhance practice-based learning and quality improvement, ultimately demonstrating the value of neurosurgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome science in practice: an overview and initial experience at the Vanderbilt Spine Center. McGirt, MJ., Speroff, T., Godil, SS., et al.[2022]

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/PMC5400713/

Using a Patient Navigator to Improve Postpartum Care in ... To estimate whether postpartum visit attendance was improved in women exposed to a postpartum patient navigation program compared with those who received ...

3. withpower.com withpower.com/trial/phase-depression-postpartum-5-2023-36725

Virtual Navigator Program for Postpartum Depression During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/imhj.22075

Patient navigation models for mental health of parents ... Patient navigation (PN) aims to improve timely access to healthcare by helping patients to “navigate” complex service provision landscapes.

5. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07479-2

Barriers to postpartum health and opinions on a postpartum ... The aim of this study is to identify postpartum challenges and assess for interest in a postpartum peer navigator program amongst refugee ...

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Digital screening for mental health in pregnancy and ... This systematic review aimed to determine if digital screening for mental health in pregnancy and postpartum is acceptable, feasible and more effective than ...

7. clinconnect.io clinconnect.io/trials/NCT06208852

Virtual Patient Navigation During a Pandemic - ClinConnect This clinical trial, titled "Virtual Patient Navigation During a Pandemic," is focused on helping women who are experiencing postpartum depression, which is a ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/phn.13226

Evaluation of the effect of a nurse navigation program ... This study aimed to determine the effects of a nurse navigation program on the capability for self-care, quality of life, risk of anxiety and depression

9. researchgate.net researchgate.net/publication/347881993_Is_Postpartum_Patient_Navigation_Uniquely_Beneficial_for_Women_with_Antenatal_Depressive_Symptoms

Is Postpartum Patient Navigation Uniquely Beneficial for ... Objective Women with depression benefit substantively from the comprehensive postpartum visit yet are less likely to attend such visits.