| NCT ID | NCT06968650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | InovCares Connected Comprehensive Healthcare Corporation |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 384 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 384 participants in total. It began in 2025-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 by providing them with free access to the InovCares mobile app. 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06968650 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06968650 currently recruiting?
Yes, NCT06968650 is actively recruiting participants. Contact the research team at cocoonedstudy@miami.edu for enrollment information.
Where is the NCT06968650 trial being conducted?
This trial is being conducted at Miami, United States, Tampa, United States.
Who is sponsoring the NCT06968650 clinical trial?
NCT06968650 is sponsored by InovCares Connected Comprehensive Healthcare Corporation. The trial plans to enroll 384 participants.