Mobile App for Stress and Depression During Pregnancy

(Cocooned Moms Trial)

Recruiting at 1 trial location

Overseen By Mohamed Kamara

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: InovCares Connected Comprehensive Healthcare Corporation

Disqualifiers: Psychosis, Non-English, Non-pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

384 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce stress, depression, and high blood pressure in pregnant Black women through a mobile app called InovCares. The app provides various support options, including therapy and community connections, all designed to be culturally sensitive. Researchers seek to understand how the app influences stress levels, mood, sleep, and blood pressure. Black pregnant women between 8 and 28 weeks along who speak English may be suitable candidates for this study.

As an unphased trial, this study presents a unique opportunity to contribute to research that could enhance health outcomes for pregnant Black women.

Do I have to stop taking my current medications for this 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 this mobile app is safe for expectant Black women?

Research shows that the InovCares app helps pregnant women manage stress and depression. Although specific safety data for the app is unavailable, the study is marked as "Not Applicable" for phases, indicating it is not a new drug or high-risk treatment. Instead, it serves as a digital tool providing support through therapy and community interaction.

The app includes programs like cognitive behavioral therapy (CBT), which is widely used and generally considered safe. Since the app focuses on offering therapy and support, it is likely well-tolerated. No reports of negative effects have emerged from using this type of digital service. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the InovCares app because it offers a fresh approach to managing stress and depression during pregnancy. Unlike traditional therapies that might rely primarily on medications or in-person therapy sessions, this app provides a culturally-sensitive telehealth platform. It combines cognitive behavioral therapy (CBT), interpersonal therapy, and compassion-focused therapy (CFT) with peer support and gamification, making mental health care more engaging and accessible. The app also addresses social determinants of health, which are often overlooked in standard treatments, aiming to improve overall well-being in Black pregnant women.

What evidence suggests that the InovCares app is effective for reducing stress and depression during pregnancy?

Research has shown that the InovCares app, which participants in this trial will use, may help reduce stress and depression in pregnant women. Studies have found that using the app can lower stress and improve sleep. The app provides access to various therapies, such as cognitive behavioral therapy (CBT), known to aid mental health. It also offers support through connections with others and engaging activities. By focusing on community care and being sensitive to cultural needs, the app aims to meet the specific needs of Black expectant mothers. Overall, the InovCares app appears promising for improving mental health during pregnancy. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

The Cocooned Moms Study is for expectant Black women who are experiencing high blood pressure, stress, or depression during pregnancy. Participants will use the InovCares mobile app to receive coordinated maternal care and mental health support.

Inclusion Criteria

I am a woman capable of making my own health decisions.

I am a Black woman, 18 or older, pregnant between 8-28 weeks with no known fetal abnormalities.

Exclusion Criteria

Does not speak or understand English

Participants who are not pregnant

Non-Black

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the InovCares mobile app, which provides access to resources addressing social determinants of health, cognitive behavioral therapy (CBT), interpersonal therapy, and compassion-focused therapy (CFT), along with peer-to-peer support and gamification.

7 months

Virtual visits via telehealth platform

Follow-up

Participants are monitored for changes in depression, anxiety, stress, and sleep quality using DASS-21 and PSQI assessments.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital and Coordinated Maternal Care

Trial Overview This study tests whether using the InovCares app can reduce stress, depressive symptoms, and blood pressure in pregnant women. The app provides culturally-sensitive telehealth services including therapy sessions and peer support.

How Is the Trial Designed?

Group I: InoVCares App use Experimental Treatment 1 Intervention

InovCares is a culturally-sensitive telehealth platform designed for community-based care coordination in maternal care. It also offers a culturally tailored maternal mental health program, which provides access to resources addressing social determinants of health, cognitive behavioral therapy (CBT), interpersonal therapy, and compassion-focused therapy (CFT), along with peer-to-peer support and gamification. The study will evaluate the impact of these interventions on reported stress levels, depressive symptoms, sleep quality, and blood pressure (BP) among Black pregnant women

Who Is Running the Clinical Trial?

InovCares Connected Comprehensive Healthcare Corporation

Lead Sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. reporter.nih.gov reporter.nih.gov/search/Q8ps-R04Rke0hc6Vb3-K9A/project-details/10821967

Project Details - NIH RePORTER AIM 1: Assess the efficacy of the InovCares platform in mitigating stress, decreasing depressive symptoms, and improving sleep quality among Black expecting ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06968650

Study Details | NCT06968650 | Cocooned Moms Study The Cocooned Moms Study is a pre- and post-design study primarily aimed at reducing stress, depressive symptoms, and blood pressure among expectant Black women.

3. withpower.com withpower.com/trial/phase-hypertension-5-2025-be61e

Mobile App for Stress and Depression During Pregnancy Trial Overview This study tests whether using the InovCares app can reduce stress, depressive symptoms, and blood pressure in pregnant women. The app provides ...

4. news.med.miami.edu news.med.miami.edu/technology-and-health-outcomes-for-black-women/

Technology and Health Outcomes for Black Women - InventUM The first study provides expectant mothers with free access to behavioral, interpersonal and compassion-focused therapy on the InovCares app.

5. hhmhealth.org hhmhealth.org/introducing-inovcares-a-revolutionary-approach-to-maternal-wellness/

Introducing InovCares: A Revolutionary Approach to ... InovCares is designed to empower mothers with comprehensive wellness programs and resources, supporting them through every stage of motherhood.

6. adaa.trialstoday.org adaa.trialstoday.org/trial/NCT06968650

Anxiety & Depression Association of America InoVCares App use, InovCares is a culturally-sensitive telehealth platform designed for community-based care coordination in maternal care.

7. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2023.1152525/full

Utilization of digital prenatal services and management ... Aim 1. To assess if using digital services and resources has an effect on perceived improvements in management of depression and anxiety during pregnancy, we ...

8. forbes.com forbes.com/sites/danabrownlee/2022/10/18/after-his-sister-and-aunt-died-from-pregnancy-related-complications-he-developed-a-virtual-gynecology-platform-for-women-of-color/

After His Sister And Aunt Died From Pregnancy Related ... “InovCares is a digital virtual care platform striving to address the maternal health crisis with collaborative and comprehensive mobile ...