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NCT06968650NARecruiting

Cocooned Moms Study

InovCares Connected Comprehensive Healthcare Corporation

Start Date

6/1/2025

Completion Date

6/1/2026

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

Age Range: 18 years to No maximum

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.

Interventions

BEHAVIORAL

Digital and Coordinated Maternial Care

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Conditions

StressDepressionPregnancyBlood Pressure

Locations

University Of Miami

Miami, Florida 33136

United States

Dr.Traci's House

Tampa, Florida 33604

United States