Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06968650

Cocooned Moms Study

Led by InovCares Connected Comprehensive Healthcare Corporation · Updated on 2025-06-15

384

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

InovCares Connected Comprehensive Healthcare Corporation

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Cocooned Moms Study

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Black women aged 18 or older with a confirmed pregnancy between 8 and 28 weeks
  • No known fetal or genetic abnormalities except abnormal amniotic fluid volume
  • Ability to provide developmental or legal consent
  • Able to speak and understand English
Not Eligible

You will not qualify if you...

  • Diagnosis of psychosis
  • Does not speak or understand English
  • Not pregnant
  • Not Black
  • Significant vision impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University Of Miami

Miami, Florida, United States, 33136

Actively Recruiting

2

Dr.Traci's House

Tampa, Florida, United States, 33604

Actively Recruiting

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Research Team

J

Judite Blanc, PhD

CONTACT

M

Mohamed Kamara

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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