[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550108":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":93,"collaborators":95,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":25,"enrollmentInfo":114,"targetDuration":25,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":127,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"A Thousand Colibris, S.L","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Participants of this group will have care as usual from healthcare providers. Participants will have the study variables measured (by questionnaires and monitoring via wearable).",[13],"Other: Monitoring via wearable",{"label":15,"type":16,"description":17,"interventionNames":18},"Mobile application","EXPERIMENTAL","Participants of this group will have access to the content of the application and will use it regularly from the start of the study until 4 months postpartum. Participants will have the study variables measured (by questionnaires and monitoring via wearable)",[19,13],"Other: Mobile application",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"OTHER","The intervention that has been developed is a digital tool of a biopsychosocial nature based on the main cognitive-behavioral strategies: psychoeducation, reflection, self-observation, guided visualizations, mindfulness and progressive muscle relaxation.\n\nThe intervention consists of 3 main areas of work:\n\n* Programs: Biopsychosocial programs in text and audio format.\n* Community: Forum with directed questions and space to share experiences between mothers.\n* Diary: Space to record mood and emotional record.\n\nThe entire tool works transversally in 4 dimensions: self-care, relationship with perinatal changes, relationship with the baby, social relationship.\n\nThe tool itself includes 3 mental health and well-being screening questionnaires: Whooley Questionnaire and the Edinburgh Postnatal Depression Scale (EPDS).",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Monitoring via wearable","Participants that own a wearable will connect it to monitor variables related to sleeping patterns, activity and stress (see variables section).",[9,15],[31],{"name":32,"affiliation":5,"role":33},"Roser Palau-Costafreda, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Veronica Montesinos","CONTACT","+34622353245","veronica@athousandcolibris.com",{"name":32,"role":37,"phone":25,"phoneExt":25,"email":41},"roser@dana.health",[43,65,77],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hospital Vall d'Hebron","RECRUITING","Barcelona","Catalonia","08550","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],2.15899,41.38879,{"lat":55,"lon":54},[58,63],{"name":59,"role":37,"phone":60,"phoneExt":61,"email":62},"Maia Brik","+34934893000","Ext 3186","maia.brik@vallhebron.cat",{"name":64,"role":33,"phone":25,"phoneExt":25,"email":25},"Maia Brik, PhD",{"facility":66,"status":45,"city":46,"state":25,"zip":67,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Hospital del Mar","08003",{"type":52,"coordinates":69},[54,55],{"lat":55,"lon":54},[72,75],{"name":73,"role":37,"phone":25,"phoneExt":25,"email":74},"Esther Insa Calderon, PhD","einsacalderon@psmar.cat",{"name":76,"role":33,"phone":25,"phoneExt":25,"email":25},"Esther Insa, PhD",{"facility":78,"status":45,"city":79,"state":25,"zip":80,"country":49,"countryCode":50,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"ASSIR Tarragona","Tarragona","43007",{"type":52,"coordinates":82},[83,84],1.24544,41.11905,{"lat":84,"lon":83},[87,91],{"name":88,"role":37,"phone":89,"phoneExt":25,"email":90},"Carmen Hernández, PhD","+34977558175","carmen.hernandez@urv.cat",{"name":92,"role":33,"phone":25,"phoneExt":25,"email":25},"Carmen Hernandez, PhD",{"type":94,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[96,98,101],{"name":97,"class":22},"Hospital Universitari Vall d'Hebron Research Institute",{"name":99,"class":100},"Universitat Rovira i Virgili (URV)","UNKNOWN",{"name":102,"class":22},"Hospital del Mar Research Institute (IMIM)","100550108","mamaconecta-digital-tool-for-maternal-mental-health-100550108",false,"NCT06442774","MamaConecta: Digital Tool for Maternal Mental Health","Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period","DDT","Inclusion Criteria:\n\n* Gestational age between 12-14 weeks of gestation.\n* The first obstetric ultrasound has been performed.\n* Women who know how to read and understand Spanish.\n* Women who have access to a mobile phone with an internet connection (data or wifi)\n* Women who have knowledge of technology tools via app.\n* Have signed the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Termination of pregnancy, or early miscarriage\n* Perinatal loss at any time during pregnancy.\n* Severe mental pathology or moderate unstable mental pathology.\n* Consumption of toxic substances.",true,"FEMALE","18 Years",{"count":115,"type":116},1200,"ESTIMATED","INTERVENTIONAL",[119],"NA","The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are:\n\n* Does the app improve overall maternal well-being during the perinatal period?\n* Can the app increase the early detection rates of perinatal mental health disorders?\n* Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems?\n* How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants?\n\nResearchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes.\n\nParticipants will:\n\n* Use the mobile application from 12-14 weeks of gestation until 24 months postpartum.\n* Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data.\n* Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old.\n\nThis trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.",[122,123,124,125,126],"Pregnancy Related","Mental Health Issue","Postpartum Depression","Postpartum Anxiety","Well-Being, Psychological",[128,129,130,131,132,133,134,135,136],"mental health","pregnancy","mobile application","wellbeing","child neurodevelopment","antenatal depression screening","early detection","postpartum","digital health","2025-01-15",{"date":139,"type":140},"2025-01-17","ACTUAL",{"date":142,"type":140},"2024-12-28",{"date":144,"type":116},"2027-12-31",{"name":5,"class":6},3]