Digital Health Solution for Postpartum Depression

Overseen By Kristen Mackiewicz Seghete, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Mindfulness-based intervention, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital health solution called Center M to help treat postpartum depression. Center M combines online group therapy with a smartphone app, offering more accessible and flexible treatment than traditional methods. Participants will either use Center M or continue with their current standard care. The trial seeks English-speaking pregnant individuals who are available for online meetings and have not participated in a similar mindfulness group before. As an unphased trial, participants can contribute to innovative research that could transform postpartum depression treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital health solution is safe for postpartum depression?

Research has shown that digital health treatments like Center M can be safe for people. Center M provides mindfulness-based therapy in a digital format, which has been studied for its effectiveness in helping with postpartum depression. These digital treatments are usually well-tolerated, with no reports of harm or serious side effects from similar therapies.

Although Center M is still under investigation, past users of digital mindfulness therapy have not encountered major safety issues. This suggests that Center M could be a safe option for treating perinatal depression. However, discussing any treatment plans with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this digital health solution for postpartum depression because it offers a new way to access care through technology. Unlike the traditional paper-based screening and educational handouts, this approach includes digital screening and four weekly telehealth sessions of Mindfulness Cognitive Behavioral Therapy. This method not only provides therapy remotely, making it more accessible for new mothers, but also includes digital materials for skill-building between sessions, helping to reinforce and practice coping strategies at home. This blend of digital innovation and therapy has the potential to make managing postpartum depression more convenient and effective.

What evidence suggests that the Center M digital health solution is effective for postpartum depression?

Research has shown that digital health tools can help reduce symptoms of postpartum depression and anxiety. Mindfulness-Based Cognitive Therapy (MBCT) is a popular method, though it has not been widely used in digital form. In this trial, participants in the Center M arm will experience a combination of MBCT with digital tools to make therapy more accessible and convenient. This approach allows new mothers to have therapy sessions online and complete exercises on a smartphone app, fitting easily into their busy lives. Early results suggest that these digital solutions can improve mental health during the postpartum period. ^{1 2 4 6 7}

Who Is on the Research Team?

Ellen Tilden, PhD, CNM, FACNM

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals aged 18-50 who speak English and can attend online group meetings. It's designed to help those experiencing depression during pregnancy, including postpartum depression.

Inclusion Criteria

You are currently expecting.

You are proficient in English.

I can attend online meetings as scheduled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive digital PD screening and four weekly one-hour group telehealth Mindfulness Cognitive Behavioral Therapy sessions with digitally delivered home practice materials

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for PD symptoms and satisfaction with care post-intervention

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Center M

Trial Overview The study compares a new telehealth program called Center M, which includes an app for homework, with the usual treatment methods for perinatal depression. Participants will be randomly assigned to one of these two options.

How Is the Trial Designed?

Group I: Center M Experimental Treatment 1 Intervention

This intervention will include digital PD screening as well as four weekly one-hour group telehealth Mindfulness Cognitive Behavioral Therapy sessions and digitally delivered home practice materials for skill building between online group sessions.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout.

Center M is already approved in United States for the following indications:

Approved in United States as Center M for:

• Perinatal Depression

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In 2011, the MedWatch system received 600,000 adverse event reports, highlighting its role in improving drug and device safety awareness, but it also faces challenges with reporting bias and data accuracy.

A study analyzing 10.2 million reports found that while patient information was mostly accurate, suspect product data was often incomplete or incorrect, with significant gaps in key details like dosage and product lot numbers, which could lead to incorrect conclusions about drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. Getz, KA., Stergiopoulos, S., Kaitin, KI.[2017]

In a study of 25,145 hospital visits, significant adverse drug events (ADEs) were identified, with 8.2% of patients on warfarin and 13.6% on heparin experiencing ADEs, highlighting the risks associated with these high-alert medications.

The presence of ADEs was linked to longer hospital stays and increased mortality rates, with an estimated 888,000 ADEs occurring among hospitalized Medicare patients, indicating a substantial burden on patient safety that could inform future healthcare policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events among hospitalized Medicare patients: epidemiology and national estimates from a new approach to surveillance. Classen, DC., Jaser, L., Budnitz, DS.[2022]

Digital health technologies can significantly enhance the management and screening of peripartum depression (PPD), which affects 10-15% of women in the U.S. annually, by utilizing a tailored framework called Digilego.

The development of specific digital features, such as 'My Diary' and 'Mom Talk', aims to improve patient engagement and address the unique needs of women experiencing PPD, with initial evaluations suggesting these features may provide technological advantages over existing solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digilego for Peripartum Depression: A Novel Patient-Facing Digital Health Instantiation. Zingg, A., Rogith, D., Refuerzo, JS., et al.[2021]

Mobile applications for postpartum depression (PPD) show promise in delivering mental health interventions, but their effectiveness in engaging women and promoting lasting behavioral changes is not well understood, as analyzed in a review of 15 commercial apps.

The study found that while these apps included an average of four behavioral change techniques, there was an inverse relationship between the number of these features and patient engagement, indicating that more features do not necessarily lead to better user involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Applications for Postpartum Depression Management: A Theory-Informed Analysis of Change-Use-Engagement (CUE) Criteria in the Digital Environment. Zingg, A., Carter, L., Rogith, D., et al.[2022]

The mobile application 'Happy Mother' was developed to help manage postpartum depression using principles of cognitive behavioral therapy, making it a potentially effective tool for mothers seeking self-management options without needing to visit a healthcare facility.

Usability testing showed that the app successfully increased awareness of mood and provided practical self-management strategies, indicating its potential to improve mental health outcomes for postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the Postpartum Depression Self-Management Mobile Application "Happy Mother". Seo, JM., Kim, SJ., Na, H., et al.[2023]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

The Mothers and Babies Online Course (eMB) was designed to prevent postpartum depression (PPD) and was accessed by 208 users, including 37% perinatal women and 63% health providers, highlighting its potential to reach those with limited access to mental health resources.

User feedback indicated that while the lessons were rated positively for usefulness, engagement was low, with only 4.4% of participants completing all eight lessons, suggesting a need for improvements in content delivery to enhance user interaction and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mothers and Babies Online Course: Participant Characteristics and Behaviors in a Web-Based Prevention of Postpartum Depression Intervention. Barrera, AZ., Morris, SY., Ruiz, A.[2022]

A machine learning model using Naive Bayes was developed to effectively predict the risk of postpartum depression (PPD) within the first week after childbirth, demonstrating a good balance of sensitivity and specificity.

The model has been integrated into a mobile health application for Android, allowing for quick and easy screening of new mothers, which can facilitate early intervention and support for those at risk of PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Application to Predict Postpartum Depression Based on Machine Learning. Jiménez-Serrano, S., Tortajada, S., García-Gómez, JM.[2022]

Postpartum depression (PPD) affects about 1 in 7 women within the first 3 months after childbirth, and if untreated, it can have long-lasting negative effects on both mothers and their children.

The MedEdPPD website was created to equip healthcare professionals with essential tools and resources for effectively screening, diagnosing, and treating PPD, and has seen significant engagement, particularly among nurses, with over 17,000 visitors and positive user feedback since its launch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based education for postpartum depression: conceptual development and impact. Wisner, KL., Logsdon, MC., Shanahan, BR.[2018]

In a pilot study involving 6 academic children's hospitals and 600 patient records, a novel pediatric trigger tool identified 240 harmful events, indicating a significant rate of 40 harms per 100 patients admitted.

Nearly half (45%) of the identified harms were deemed potentially or definitely preventable, highlighting the need for improved safety measures in pediatric inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trigger tool to detect harm in pediatric inpatient settings. Stockwell, DC., Bisarya, H., Classen, DC., et al.[2022]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

The MamaLift Plus app was evaluated by 14 participants over a 2-week period and was found to be an acceptable and highly usable tool for managing postpartum depression (PPD).

Participants indicated that the app is practical for weekly use, suggesting it could be a valuable resource for individuals with limited access to traditional mental health care, highlighting the need for further research in digital behavioral health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptance of using a digital technology to manage postpartum depression. Tang, JJ., Malladi, I., Covington, MT., 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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212657025000029

Efficacy of digital MBCT-PD in preventing postpartum ... While preventive measures are essential, the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in this context remains underexplored. This study will ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37330123/

The effect of digital health interventions on postpartum ... Digital health interventions modestly, but significantly, reduced scores assessing postpartum depression and postpartum anxiety symptoms.

4. withpower.com withpower.com/trial/phase-depression-2024-b5049

Digital Health Solution for Postpartum Depression This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to ...

5. binasss.sa.cr binasss.sa.cr/ene24/5.pdf

Systematic Reviews - The effect of digital health ... for postpartum depression (n¼4) or postpartum anxiety (n¼1), there were no significant differences between those randomized to digital health intervention and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06000449/center-m-digital-health-innovation-pilot

Center M: Digital Health Innovation Pilot Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy ...

7. 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 ( ...