Cocooned Moms Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital and Coordinated Maternial Care.
- Who it may be relevant to
- Registry conditions: Stress, Depression, Pregnancy, Blood Pressure. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care
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.
Interventions
- Behavioral Digital and Coordinated Maternial Care
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
Primary outcome measures
- Change in depression, anxiety, and stress as measured by Depression Anxiety Stress Scales- Short Form (DASS-21) [Time frame: Up to 7 months]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Up to 7 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- University Of Miami — Miami
- Dr.Traci's House — Tampa
Publications
- DeNicola N, Grossman D, Marko K, Sonalkar S, Butler Tobah YS, Ganju N, Witkop CT, Henderson JT, Butler JL, Lowery C. Telehealth Interventions to Improve Obstetric and Gynecologic Health Outcomes: A Systematic Review. Obstet Gynecol. 2020 Feb;135(2):371-382. doi: 10.1097/AOG.0000000000003646. PMID 31977782
- Blanc J, Scaramutti C, Carrasco M, Dimanche S, Hollimon L, Moore J, Moise R, Gabbay V, Seixas A. I am Lifted Above the World: utilizing VR for stress reduction among perinatal women of color. Front Psychiatry. 2024 Apr 23;15:1377978. doi: 10.3389/fpsyt.2024.1377978. eCollection 2024. PMID 38716116
Identifiers
NCT: NCT06968650 · 20240737 · R41NR021628-01