Recruiting

Cocooned Moms Study

ClinicalTrials.gov IDNCT06968650

PhaseNA

Enrollment384

SponsorInovCares Connected Comprehensive Healthcare Corporation

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Stress, Depression, Pregnancy, Blood Pressure

About this study

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.

Interventions

Behavioral: Digital and Coordinated Maternial Care — 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.

Primary outcomes

Change in depression, anxiety, and stress as measured by Depression Anxiety Stress Scales- Short Form (DASS-21) (Up to 7 months)
Pittsburgh Sleep Quality Index (PSQI) (Up to 7 months)

Eligibility information

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 locations

University Of Miami, Miami, Florida 33136 United States
Dr.Traci's House, Tampa, Florida 33604 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.