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NCT Number: NCT06968650

Cocooned Moms 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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Blood Pressure Depression Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Up to 7 months

    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

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Up to 7 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Judite Blanc, PhD

CONTACT

[email protected]

3052437452

Mohamed Kamara

CONTACT

[email protected]

(614) 749-4256

Sponsors and collaborators

Lead sponsor

InovCares Connected Comprehensive Healthcare Corporation

Industry

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: Cocooned Moms

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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