Cocooned Moms: App-based maternal mental health and care coordination for pregnant Black women
Official title: Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care
Run by InovCares Connected Comprehensive Healthcare Corporation · NCT06968650 · Data updated 2026-11-12
This project will test whether free access to the culturally tailored InovCares mobile app can lower stress, depressive symptoms, improve sleep, and reduce blood pressure in pregnant Black women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 384 (estimated) |
| Sponsor | InovCares Connected Comprehensive Healthcare Corporation Industry-sponsored |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | June 15, 2025 |
| Trial ID | NCT06968650 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking Black women aged 18 or older who are 8–28 weeks pregnant, able to consent, and without a psychosis diagnosis or significant vision impairment.
✕Probably not a fit
People who are not pregnant, non-Black, non-English speakers, those with psychosis, or those with significant vision impairment are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Cocooned Moms uses a pre- and post-intervention design to give pregnant Black women free access to the InovCares mobile app, a culturally sensitive telehealth platform for community-based maternal care coordination. The app provides a tailored maternal mental health program including CBT, interpersonal therapy, compassion-focused therapy, peer support, gamification, and resources addressing social determinants of health. Outcomes measured before and after the intervention include self-reported stress, depressive symptoms, sleep quality, and blood pressure. Participants are English-speaking Black women aged 18+ who are between 8 and 28 weeks pregnant, and the study is conducted at sites in Miami and Tampa, Florida with digital components delivered via the app.
Why it matters
Potential benefit: If successful, participants may experience reduced stress and depressive symptoms, better sleep, and improved blood pressure control during pregnancy.
How similar studies have gone: Previous digital CBT and telehealth interventions have shown modest success for perinatal depression and stress, and culturally tailored programs for Black mothers show promise though large randomized trials are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Black Women ages 18 + with confirmed pregnancy of at least eight or up to 28 weeks, with no known fetal or genetic abnormalities (with the exception of abnormal amniotic fluid volume; Women who have the developmental or legal capacity to consent; Able to speak English Exclusion Criteria: * Exclusion criteria 1. Psychosis diagnosis 2. Does not speak or understand English 3. Participants who are not pregnant 4. Non-Black 5. Significant vision impairment.
Where it's running
-
University Of Miami
Miami, Florida, United States Recruiting -
Dr.Traci's House
Tampa, Florida, United States Recruiting
Study contacts
- Study coordinator: Judite Blanc, PhD
- Email: cocoonedstudy@miami.edu
- Phone: 3052437452
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.