Cocooned Moms Study

InovCares Connected Comprehensive Healthcare Corporation384 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

384

Conditions

Stress Depression Pregnancy Blood Pressure

Interventions

Digital and Coordinated Maternial CareBEHAVIORAL

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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