NCT06968650

Cocooned Moms Study

Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: InovCares Connected Comprehensive Healthcare Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress
• Depression
• Pregnancy
• Blood Pressure

Interventions

Type	Name	Description
BEHAVIORAL	Digital and Coordinated Maternial Care	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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-05-13
• Last updated: 2025-06-15

Locations

2 sites across 1 country: United States