Cocooned Moms Study

InovCares Connected Comprehensive Healthcare Corporation

Status: Not yet enrolling

Conditions: Depression; Blood Pressure; Pregnancy; Stress

Treatments: Behavioral: Digital and Coordinated Maternial Care

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06968650

20240737

R41NR021628-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 384 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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384 participants in 1 patient group

InoVCares App use

Experimental group

Description:

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

Treatment:

Behavioral: Digital and Coordinated Maternial Care