Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-31 @ 2:18 AM
Study NCT ID:
NCT06968650
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cocooned Moms Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-05-05', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depression, anxiety, and stress as measured by Depression Anxiety Stress Scales- Short Form (DASS-21)', 'timeFrame': 'Up to 7 months', 'description': '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.\n\nStress 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'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Up to 7 months', 'description': 'The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month interval.\n\nIt 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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Depression', 'Pregnancy', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '31977782', 'type': 'BACKGROUND', 'citation': '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': '38716116', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://reporter.nih.gov/search/z4cbsZQqzUqIS2QbptonSg/projects', 'label': 'NIH Reporter'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-Indentified Black Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 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\n\nExclusion Criteria:\n\n* Exclusion criteria\n\n 1. Psychosis diagnosis\n 2. Does not speak or understand English\n 3. Participants who are not pregnant\n 4. Non-Black\n 5. Significant vision impairment.'}, 'identificationModule': {'nctId': 'NCT06968650', 'acronym': 'Cocooned Moms', 'briefTitle': 'Cocooned Moms Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'InovCares Connected Comprehensive Healthcare Corporation'}, 'officialTitle': 'Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care', 'orgStudyIdInfo': {'id': '20240737'}, 'secondaryIdInfos': [{'id': 'R41NR021628-01', 'link': 'https://reporter.nih.gov/quickSearch/R41NR021628-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'InoVCares App use', 'description': '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', 'interventionNames': ['Behavioral: Digital and Coordinated Maternial Care']}], 'interventions': [{'name': 'Digital and Coordinated Maternial Care', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['InoVCares App use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Judite Blanc, PhD', 'role': 'CONTACT', 'email': 'juditeblanc@miami.edu', 'phone': '305-243-7542'}], 'facility': 'University Of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33604', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Traci Thompson, MD', 'role': 'CONTACT', 'email': 'drtraci@drtracishouse.org', 'phone': '813-510-5105'}], 'facility': "Dr.Traci's House", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Judite Blanc, PhD', 'role': 'CONTACT', 'email': 'cocoonedstudy@miami.edu', 'phone': '3052437452'}, {'name': 'Mohamed Kamara', 'role': 'CONTACT', 'email': 'mkamara@inovcares.com', 'phone': '(614) 749-4256'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InovCares Connected Comprehensive Healthcare Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}