Clinical Trial

Cocooned Moms Study

Study acronym: Cocooned Moms

Recruiting

Record status

This record was last updated June 15, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2025-05-05.

Status change: Not Yet Recruiting → Recruiting 2025-06-13

Trial Details

NCT Number	NCT06968650
Lead Sponsor	InovCares Connected Comprehensive Healthcare Corporation Collaborators: National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR)
Conditions	Stress, Depression, Pregnancy, Blood Pressure
Enrollment	384 participants
Start Date	2025-06-01
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-15