- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06968650
Culturally-Sensitive Telehealth for Black Maternal Mental Health Study
Study Overview: This clinical trial investigates the efficacy of InovCares, a culturally-sensitive telehealth platform, in improving maternal mental health outcomes for Black pregnant women. The study focuses on reducing stress, depressive symptoms, and blood pressure through a comprehensive digital intervention program.
Intervention Details: Participants will receive access to the InovCares mobile app, which provides:
- Culturally-tailored mental health resources
- Evidence-based therapies (CBT, interpersonal therapy, compassion-focused therapy)
- Peer support networks
- Gamification elements to encourage engagement
- Resources addressing social determinants of health
Study Population: The trial will enroll 384 adult Black women between 8-28 weeks of pregnancy with no known fetal abnormalities. Participants must be English-speaking and without significant vision impairment or psychosis diagnosis.
Key Measurements: Researchers will assess changes in:
- Psychological distress (DASS-21 scale)
- Sleep quality (Pittsburgh Sleep Quality Index)
- Blood pressure levels
Study Duration: The intervention period lasts up to 7 months, with data collection continuing through June 2026. This NIH-supported study represents an important step toward addressing health disparities in maternal care through technology-enabled solutions.
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