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Cocooned Moms Study

RECRUITINGN/ASponsored by InovCares Connected Comprehensive Healthcare Corporation
Actively Recruiting
PhaseN/A
SponsorInovCares Connected Comprehensive Healthcare Corporation
Started2025-06-01
Est. completion2026-06-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions4

Blood PressureDepressionPregnancyStress

Locations2 sites

University Of Miami
Miami, Florida, 33136
Judite Blanc, PhD305-243-7542juditeblanc@miami.edu
Dr.Traci's House
Tampa, Florida, 33604
Traci Thompson, MD813-510-5105drtraci@drtracishouse.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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