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Cocooned Moms Study

Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether free access to the InovCares app helps lower stress, signs of depression, and blood pressure in Black pregnant women. The app offers mental health care, resources, and support from peers. The study also checks sleep quality.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Black women age 18 or older.
  • Confirmed pregnancy between 8 and 28 weeks.
  • No known problems with the baby's development or genes, except an unusual amount of fluid around the baby.
  • Able to understand and give consent to join the study.
  • Able to speak English.

Who can't join

  • Diagnosed with psychosis, a condition that affects a person's sense of what is real.
  • Cannot speak or understand English.
  • Not pregnant.
  • Not Black.
  • Have major trouble seeing.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 1. Psychosis diagnosis 2. Does not speak or understand English 3. Participants who are not pregnant 4. Non-Black 5. Significant vision impairment.

Study sites (2)

FL