[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06968650":3,"trial-entities:NCT06968650":105,"trial-summary:NCT06968650":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":84,"overall_officials":92,"references":93,"see_also_links":101},"NCT06968650","20240737","Cocooned Moms Study","Efficacy of a Culturally-sensitive Telehealth Platform in Fostering Community-based Care Coordination for Respectful Maternal Care","RECRUITING","2026-06-01","2025-06","2025-06-15","2025-06-01","InovCares Connected Comprehensive Healthcare Corporation","INDUSTRY",true,"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.",null,[19,20,21,22],"Stress","Depression","Pregnancy","Blood Pressure",[],"INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},384,"ESTIMATED",[32],{"type":33,"name":34,"description":16,"armGroupLabels":35},"BEHAVIORAL","Digital and Coordinated Maternial Care",[36],"InoVCares App use",[38,42],{"measure":39,"description":40,"timeFrame":41},"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.\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","Up to 7 months",{"measure":43,"description":44,"timeFrame":41},"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.\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",[],"FEMALE","18 Years",false,{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"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.",[54,55],"ADULT","OLDER_ADULT",[57,72],{"facility":58,"status":8,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":69},"University Of Miami","Miami","Florida","33136","United States",[64],{"name":65,"role":66,"phone":67,"email":68},"Judite Blanc, PhD","CONTACT","305-243-7542","juditeblanc@miami.edu",{"lat":70,"lon":71},25.77427,-80.19366,{"facility":73,"status":8,"city":74,"state":60,"zip":75,"country":62,"contacts":76,"geoPoint":81},"Dr.Traci's House","Tampa","33604",[77],{"name":78,"role":66,"phone":79,"email":80},"Traci Thompson, MD","813-510-5105","drtraci@drtracishouse.org",{"lat":82,"lon":83},27.94752,-82.45843,[85,88],{"name":65,"role":66,"phone":86,"email":87},"3052437452","cocoonedstudy@miami.edu",{"name":89,"role":66,"phone":90,"email":91},"Mohamed Kamara","(614) 749-4256","mkamara@inovcares.com",[],[94,98],{"pmid":95,"type":96,"citation":97},"31977782","BACKGROUND","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\u002FAOG.0000000000003646.",{"pmid":99,"type":96,"citation":100},"38716116","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\u002Ffpsyt.2024.1377978. eCollection 2024.",[102],{"label":103,"url":104},"NIH Reporter","https:\u002F\u002Freporter.nih.gov\u002Fsearch\u002Fz4cbsZQqzUqIS2QbptonSg\u002Fprojects",{"nct_id":4,"conditions":106,"biomarkers":108},[20,107,19],"Hypertension",[],{"nct_id":4,"found":15,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This study is designed to see how participants change before and after using the InovCares mobile app. It plans to enroll 384 participants.","completed","Cocooned Moms Study for Stress and Depression in Pregnancy","The Cocooned Moms Study is looking for pregnant Black women (ages 18 and older, between 8 and 28 weeks pregnant) to participate. This study aims to reduce stress, symptoms of depression, and high blood pressure. You would receive free access to the InovCares mobile app, which is a telehealth platform offering culturally sensitive care, mental health support (like cognitive behavioral therapy), and peer support. The study will measure changes in your depression, anxiety, and stress levels, as well as sleep quality, over a period of up to 7 months. We are currently enrolling participants.","Participants will be followed for up to 7 months to measure changes in depression, anxiety, stress, and sleep quality.",94,"You would use the InovCares mobile app. Your depression, anxiety, stress, and sleep quality will be measured for up to 7 months.","Not stated in the trial record.",[],"v2"]