Recruiting

InovCares

Sponsor:

InovCares Connected Comprehensive Healthcare Corporation

Code:

NCT06968650

Conditions

Stress

Depression

Pregnancy

Blood Pressure

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital and Coordinated Maternial Care

Study Details

Brief 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.

Conditions

Stress

Depression

Pregnancy

Blood Pressure

Study ID

NCT06968650

Start date

Jun 1, 2025

Status verified date

Jun, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

384 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: InoVCares App use

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

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 outcome measure

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

Central Contacts and Locations

Central contacts

Judite Blanc, PhD

3052437452cocoonedstudy@miami.edu

Mohamed Kamara

(614) 749-4256mkamara@inovcares.com

Locations

University Of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Judite Blanc, PhD

305-243-7542juditeblanc@miami.edu

Dr.Traci's House

Recruiting

Tampa, Florida, United States, 33604

Contacts

Traci Thompson, MD

813-510-5105drtraci@drtracishouse.org

More Information

Sponsor

InovCares Connected Comprehensive Healthcare Corporation

Last update posted

Jun 15, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by InovCares Connected Comprehensive Healthcare Corporation on 2025-06-15.