Behavioral Intervention App for Postpartum Depression

(eROSE Trial)

Overseen By Tamara Bilinski

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Acute mental health needs, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to assist individuals at risk for postpartum depression. It compares a new app, InBloom, with an existing program, ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns), and two control groups to determine which approach more effectively reduces depression symptoms. Researchers will track participants' depression levels, satisfaction, and access to care over several months. The study seeks individuals who are 17 to 32 weeks pregnant, enrolled in prenatal care, speak English, can use an app, and have certain risk factors such as anxiety or prior depression treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for new 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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these behavioral interventions are safe for postpartum depression?

Research has shown that the ROSE program helps pregnant individuals reduce their risk of postpartum depression by offering essential skills and information for mental health. No serious side effects have been reported, suggesting it is well-tolerated.

The InBloom app, a newer tool, also aims to prevent postpartum depression. While less information is available about its safety in individuals due to ongoing testing, its nature as an app generally suggests fewer side effects than medication-based treatments. Both the ROSE program and the InBloom app focus on behavioral methods, indicating they are likely safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the Behavioral Intervention App for Postpartum Depression because it explores innovative, digital solutions to a common and often challenging condition. Unlike traditional treatments such as therapy or medication, the InBloom app offers a flexible and accessible way for new mothers to receive support and intervention through their smartphones. The InBloom app leverages technology to potentially reach a wider audience, making it easier for women to access help without the need for in-person visits. This approach could lead to more personalized and immediate support, addressing postpartum depression in a way that fits into the busy lives of new mothers.

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

Research has shown that the InBloom app, available to participants in this trial, might help prevent postpartum depression. Early results suggest that the app can reduce depression symptoms in new mothers. It operates on a smartphone, allowing use anytime and anywhere.

Meanwhile, the ROSE program, another treatment option in this trial, has proven effective in lowering the risk of postpartum depression. This program provides new mothers with useful skills and information to manage their mental health. Both InBloom and ROSE offer promising ways to support mental well-being after childbirth. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals between 20-35 weeks along, who are at risk for postpartum depression. They must be English-speaking and receiving prenatal care at certain practices. Eligible participants may have a low income, anxiety or mild to moderate depressive symptoms during pregnancy, a history of depression treatment, gestational diabetes, or be aged 18-21.

Inclusion Criteria

Enrolled for prenatal care in one of the five identified practices

Able to use an app (audio/visual/dexterity)

I am between 17 and 32 weeks pregnant.

Exclusion Criteria

Patients with acute mental health needs

PHQ-9 depression score > 19

I have significant memory or thinking problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the InBloom app or ROSE intervention, with assessments at baseline and monthly intervals

3 months

Monthly assessments

Follow-up

Participants are monitored for depression severity, ROI, and satisfaction after treatment

5 months

What Are the Treatments Tested in This Trial?

Interventions

• eROSE
• ROSE

Trial Overview The study compares the effectiveness of two apps: InBloom and ROSE in preventing postpartum depression among pregnant people at risk. Participants will be randomly assigned to one of these interventions or control groups and followed from mid-pregnancy through three months after birth.

How Is the Trial Designed?

Group I: women receiving InBloom app Experimental Treatment 1 Intervention

Group II: electronic health record utilization data Active Control 1 Intervention

We will leverage EHR utilization data by retrospectively identifying 152 people from the same clinics who did not receive ROSE or InBloom and matched for eligibility criteria, demographics and PPD risk factors using propensity scores, and comparing their utilization to those in the ROSE and InBloom groups.

Group III: women receiving ROSE as usual Active Control 1 Intervention

Group IV: historical controls- no treatment Active Control 1 Intervention

We will capitalize on data from a large ROSE trial which consists of a demographically similar sample by comparing depression diagnosis outcomes for Inbloom and ROSE to the 96 participants in the care as usual group (an educational pamphlet on PPD).

eROSE is already approved in United States for the following indications:

Approved in United States as ROSE for:

• Prevention of postpartum depression

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A telephone-based screening protocol for postpartum depression (PPD) was developed and implemented, successfully identifying symptoms in 52% of women screened between 2 and 3 weeks postpartum.

The protocol led to high acceptance rates for referrals, with 64% of women accepting both provider and support services, and follow-through rates of 89% for provider referrals and 78% for support referrals, highlighting the efficacy of early screening and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uncovering the Golden Veil: Applying the Evidence for Telephone Screening to Detect Early Postpartum Depression. BenDavid, DN., Hunker, DF., Spadaro, KC.[2020]

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]

This study will evaluate the feasibility and acceptability of an 8-week guided cognitive-behavioral app-based intervention for postpartum women in Chile, addressing the high prevalence of postpartum depression and the need for accessible treatments.

If successful, this will be the first internet-based intervention for postpartum depression in Chile, potentially leading to a larger trial to assess its efficacy and integration into the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-based intervention for reducing depressive symptoms in postpartum women: Protocol for a feasibility randomized controlled trial. Franco, P., Olhaberry, M., Cuijpers, P., et al.[2023]

An interactive coaching intervention significantly improved maternal-infant responsiveness among 117 postpartum women, indicating its effectiveness in enhancing mother-infant interactions.

While the intervention did not reduce postpartum depressive symptoms, both treatment and control groups showed improvements in responsiveness and a decrease in depression scores over time, suggesting that factors beyond the intervention may contribute to these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting responsiveness between mothers with depressive symptoms and their infants. Horowitz, JA., Bell, M., Trybulski, J., et al.[2019]

Public health nurses in a Norwegian municipality found the postpartum depression (PPD) screening procedure valuable, as it increased their confidence in discussing mental health issues with parents.

The use of the Edinburgh Postnatal Depression Scale allowed nurses to identify PPD more frequently, indicating that the screening process is effective in recognizing mental health problems in new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Norwegian public health nurses' experience using a screening protocol for postpartum depression. Glavin, K., Ellefsen, B., Erdal, B.[2010]

A behavioral educational intervention aimed at reducing postpartum depressive symptoms was tested in a randomized trial with 540 predominantly white, high-income mothers, focusing on modifiable factors and social support.

Despite the intervention's design, the overall prevalence of depressive symptoms was unexpectedly low among participants, resulting in no significant differences in depressive symptoms between the intervention and control groups at 3 weeks, 3 months, and 6 months postpartum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention to reduce postpartum depressive symptoms: a randomized controlled trial. Howell, EA., Bodnar-Deren, S., Balbierz, A., et al.[2022]

In a 6-month project involving 273 mothers, a screening protocol for postpartum depression (PPD) was successfully implemented, achieving an 83.5% screening rate during well-child visits.

Of the mothers who screened positive for PPD, 73.1% were referred to mental health services, and 63.2% attended their referral, demonstrating effective follow-up and support for those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. Cohen, M., Stephens, CTD., Zaheer, A., et al.[2022]

The ROSE postpartum depression prevention program will be tested on 2320 pregnant individuals to evaluate its effectiveness as a universal prevention strategy, compared to selective or indicated prevention methods.

This study aims to provide insights into the cost-effectiveness, equity, and scalability of the ROSE program, making it the largest trial of its kind to date, which could influence future guidelines on postpartum depression prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. Johnson, JE., Loree, AM., Sikorskii, A., et al.[2023]

The ROSE sustainment (ROSES) study is evaluating the effectiveness and cost-effectiveness of a stepwise approach to sustaining a postpartum depression prevention program in 90 outpatient clinics, aiming to reduce postpartum depression rates among low-income pregnant women.

This study is the first randomized trial to assess the return on investment (ROI) of sustainment strategies in implementation science, which will provide valuable insights into maintaining effective interventions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women. Johnson, JE., Wiltsey-Stirman, S., Sikorskii, A., et al.[2023]

In a prospective study of postpartum women in Israel, 76% participated in a screening initiative for postpartum depression (PPD) at 6 weeks postpartum, highlighting a significant level of engagement in mental health screening.

Factors such as having three or more children, a family history of depression, and positive attitudes toward seeking help were linked to higher participation rates, suggesting that tailored screening programs could improve compliance among diverse socio-demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for postpartum depression: What influences participation? Bina, R.[2020]

The 'Be a Mom' web-based intervention, based on cognitive behavioral therapy, showed preliminary efficacy in reducing depressive and anxiety symptoms in postpartum women, with significant improvements observed in the intervention group compared to the control group (p < .05).

Although only 41.8% of participants completed the program, a majority (71.4%) expressed willingness to use 'Be a Mom' again, indicating its acceptability and feasibility, but further research is needed to confirm its effectiveness as a preventive measure for persistent postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Results From a Pilot Randomized Controlled Trial. Fonseca, A., Alves, S., Monteiro, F., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003835

Randomized clinical trial protocol of an app-based ... Outcomes will be assessed 1-, 2- and 3- months postpartum and include depression diagnosis, depressive symptoms, and ROI. Sample size. We determined a sample ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05518162

Treatment of Post-partum Depression Using an Behavioral ... A randomized trial of pregnant people at risk for postpartum depression comparing the InBloom app ... InBloom App vs ROSE Outcomes and Mechanisms.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39743016/

Randomized clinical trial protocol of an app-based ... Purpose: To develop and evaluate the effectiveness of an asynchronously delivered app, InBloom, for postpartum depression (PPD) prevention ...

4. withpower.com withpower.com/trial/phase-depressive-disorder-6-2023-6c424

Behavioral Intervention App for Postpartum Depression Trial Overview The study compares the effectiveness of two apps: InBloom and ROSE in preventing postpartum depression among pregnant people at risk.

5. 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.

6. mentalhealthdataprizeafrica.aphrc.org mentalhealthdataprizeafrica.aphrc.org/repository/paper/45293/randomized-clinical-trial-protocol-of-an-app-based-intervention-to-prevent-postpartum-depression

Randomized clinical trial protocol of an app-based ... To develop and evaluate the effectiveness of an asynchronously delivered app, InBloom, for postpartum depression (PPD) prevention relative to an evidence-based ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Post-partum%20Depression%22

San Mateo Clinical Trials ~The purpose of this study is to determine the maternal mental health effect of postpartum depression screening and intervention during infants' short term ...