What this study is
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.
What's being tested
- Digital and Coordinated Maternial Care
Intervention · BEHAVIORAL
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.
Study details
- Official title
- Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care
- Sponsor
- InovCares Connected Comprehensive Healthcare Corporation
- Conditions
- Stress · Depression · Pregnancy · Blood Pressure
- Enrolling
- 384 people
- Starts
- 2025-06-01
- Est. completion
- 2026-06-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Psychosis diagnosis
- Does not speak or understand English
- Participants who are not pregnant
- Non-Black
- Significant vision impairment.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity Of Miami
Miami, Florida, United States
- Judite Blanc, PhD · Contact305-243-7542juditeblanc@miami.edu
RecruitingDr.Traci's House
Tampa, Florida, United States
- Traci Thompson, MD · Contact813-510-5105drtraci@drtracishouse.org
Recruiting
Study team
Sponsor
InovCares Connected Comprehensive Healthcare Corporation
Study ID 20240737
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.