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Cocooned Moms Study

InovCares Connected Comprehensive Healthcare Corporation · with National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR) · NCT06968650

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
384
US sites recruiting
2
Study start
June 1, 2025
Record last updated
June 15, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Digital and Coordinated Maternial Care

Conditions: Stress; Depression; Pregnancy; Blood Pressure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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
  • Psychosis diagnosis
  • Does not speak or understand English
  • Participants who are not pregnant
  • Non-Black
  • Significant vision impairment.

Recruiting US locations

  • University Of Miami

    Miami, FL 33136

    Site contact: Judite Blanc, PhD · 305-243-7542 · juditeblanc@miami.edu

  • Dr.Traci's House

    Tampa, FL 33604

    Site contact: Traci Thompson, MD · 813-510-5105 · drtraci@drtracishouse.org

Study contacts (from the official record)

  • Judite Blanc, PhD · 3052437452 · cocoonedstudy@miami.edu
  • Mohamed Kamara · (614) 749-4256 · mkamara@inovcares.com
All mental health studies in Florida →
Cocooned Moms Study (NCT06968650) | Bored Studies