Cocooned Moms Study

NCT06968650 | Recruiting DMC

• 2 other identifiers: 20240737R41NR021628-01
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Change in depression, anxiety, and stress as measured by Depression Anxiety Stress Scales- Short Form (DASS-21)

  The DASS-21 at 21-items self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress in adults and older adolescents. The DASS adopts a dimensional approach to psychopathology, emphasizing the degree of symptom severity rather than using diagnostic cut-offs. The overall DASS-21 score provides an indication of general psychological distress. Stress Subscale: The stress subscale of the DASS-21 assesses symptoms such as difficulty relaxing, nervous arousal, and being easily upset or agitated, irritable, over-reactive, or impatient. Anxiety Subscale: The anxiety subscale evaluates symptoms including autonomic arousal, effects on skeletal muscles, situational anxiety, and the subjective experience of anxious affect

  Up to 7 months

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month interval. It is frequently employed in both clinical and research settings to evaluate various aspects of sleep. The PSQI captures multiple dimensions of sleep, incorporating both subjective experiences and objective parameters. Each of the seven component scores ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The component scores are summed to produce a global PSQI score, which ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score greater than 5 suggests significant sleep difficulties

  Up to 7 months

Study Arms (1)

InoVCares App use

EXPERIMENTAL

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

Behavioral: Digital and Coordinated Maternial Care

Interventions

Digital and Coordinated Maternial Care BEHAVIORAL

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.

InoVCares App use

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-Indentified Black Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• InovCares Connected Comprehensive Healthcare Corporation: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

University Of Miami

Miami, Florida, 33136, United States

RECRUITING

Dr.Traci's House

Tampa, Florida, 33604, United States

RECRUITING

Related Publications (2)

• DeNicola N, Grossman D, Marko K, Sonalkar S, Butler Tobah YS, Ganju N, Witkop CT, Henderson JT, Butler JL, Lowery C. Telehealth Interventions to Improve Obstetric and Gynecologic Health Outcomes: A Systematic Review. Obstet Gynecol. 2020 Feb;135(2):371-382. doi: 10.1097/AOG.0000000000003646.

  PMID: 31977782 BACKGROUND

• Blanc J, Scaramutti C, Carrasco M, Dimanche S, Hollimon L, Moore J, Moise R, Gabbay V, Seixas A. I am Lifted Above the World: utilizing VR for stress reduction among perinatal women of color. Front Psychiatry. 2024 Apr 23;15:1377978. doi: 10.3389/fpsyt.2024.1377978. eCollection 2024.

  PMID: 38716116 BACKGROUND

Related Links

• NIH Reporter

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Judite Blanc, PhD

CONTACT

3052437452; cocoonedstudy@miami.edu

Mohamed Kamara

CONTACT

(614) 749-4256; mkamara@inovcares.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)