Cocooned Moms Study for Stress and Depression in Pregnancy

The Cocooned Moms Study is looking for pregnant Black women (ages 18 and older, between 8 and 28 weeks pregnant) to participate. This study aims to reduce stress, symptoms of depression, and high blood pressure. You would receive free access to the InovCares mobile app, which is a telehealth platform offering culturally sensitive care, mental health support (like cognitive behavioral therapy), and peer support. The study will measure changes in your depression, anxiety, and stress levels, as well as sleep quality, over a period of up to 7 months. We are currently enrolling participants.

Study design
This study is designed to see how participants change before and after using the InovCares mobile app. It plans to enroll 384 participants.
What's involved
You would use the InovCares mobile app. Your depression, anxiety, stress, and sleep quality will be measured for up to 7 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 7 months to measure changes in depression, anxiety, stress, and sleep quality.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06968650

Cocooned Moms Study

Recruiting
NAAges 18+InterventionalPrevention
InovCares Connected Comprehensive Healthcare Corporation
~384 participants
Updated 2025-06-15 on ClinicalTrials.gov
What's tested:Digital and Coordinated Maternial Care

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in depression, anxiety, and stress as measured by Depression Anxiety Stress Scales- Short Form (DASS-21)
Measured over Up to 7 months
+1 more outcome measured
Stress
Depression
Pregnancy
Blood Pressure
2 sites across 1 states
Florida2

Opens a ready-to-send draft in your own email app — review before sending.

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

  • Pittsburgh Sleep Quality Index (PSQI)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