Mobile App for Stress and Depression During Pregnancy

(Cocooned Moms Trial)

Recruiting at 1 trial location

Overseen By Mohamed Kamara

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: InovCares Connected Comprehensive Healthcare Corporation

Disqualifiers: Psychosis, Non-English, Non-pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

384 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

The Cocooned Moms Study is for expectant Black women who are experiencing high blood pressure, stress, or depression during pregnancy. Participants will use the InovCares mobile app to receive coordinated maternal care and mental health support.

Inclusion Criteria

I am a woman capable of making my own health decisions.

I am a Black woman, 18 or older, pregnant between 8-28 weeks with no known fetal abnormalities.

Exclusion Criteria

Does not speak or understand English

Participants who are not pregnant

Non-Black

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the InovCares mobile app, 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.

7 months

Virtual visits via telehealth platform

Follow-up

Participants are monitored for changes in depression, anxiety, stress, and sleep quality using DASS-21 and PSQI assessments.

4 weeks

Treatment Details

Interventions

• Digital and Coordinated Maternal Care

Trial Overview This study tests whether using the InovCares app can reduce stress, depressive symptoms, and blood pressure in pregnant women. The app provides culturally-sensitive telehealth services including therapy sessions and peer support.

Participant Groups

Group I: InoVCares App use Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

InovCares Connected Comprehensive Healthcare Corporation

Lead Sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+