[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637378":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":11,"responsibleParty":39,"collaborators":42,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":11},{"fullName":5,"class":6},"University of Seville","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR",null,[13],"Other: Standard routine maternal care",{"label":15,"type":16,"description":11,"interventionNames":17},"Intervention group","EXPERIMENTAL",[18],"Behavioral: The e-Perinatal intervention is a personalized mobile health (mHealth) program",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BEHAVIORAL","The e-Perinatal intervention is a personalized mobile health (mHealth) program","The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care.\n\nParticipants will use the app from recruitment (pregnancy) until 12 months of postpartum.",[15],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Standard routine maternal care","Participants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.",[9],[30],{"name":31,"affiliation":5,"role":32},"Emma Motrico, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Emma Motrico, PhD Psychology","CONTACT","0034636995778","eperinatal@us.es",{"type":32,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Emma Motrico","Professor of Psychology",[43,46],{"name":44,"class":45},"Junta de Andalucia","OTHER_GOV",{"name":47,"class":45},"Health Service of Andalucia","100637378","effectiveness-and-implementation-of-a-personalized-mhealth-intervention-for-the-universal-prevention-of-maternal-perinatal-mental-disorders-100637378",false,"NCT07613008","Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders","Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial","ePerinatal-RCT","Inclusion Criteria:\n\n\\- Inclusion Criteria (Women)\n\nMust receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers\n\nMust be pregnant for at least 11 weeks at the time of enrollment\n\nMust be at least 18 years old\n\nMust have access to a mobile phone and internet connection\n\nMust be able to read, write, and understand Spanish\n\nMust have a personal email account\n\nNo diagnosis of depression or anxiety disorder at baseline Forma\n\n\\- Inclusion Criteria (Partners or significant others)\n\nMust receive an invitation to participate from a woman already enrolled in the study\n\nMust be at least 18 years old\n\nMust have access to a mobile phone and internet connection\n\nMust be able to read, write, and understand Spanish\n\nMust have a personal email account\n\nExclusion Criteria:\n\n* Exclusion Criteria (Women)\n\nCurrent diagnosis of depression or anxiety disorder\n\nReceiving psychological or pharmacological treatment for mental health or substance use conditions\n\n\\- Exclusion criteria for partners (or significant others):\n\nThere are no exclusion criteria for partners",true,"ALL","18 Years",{"count":60,"type":61},3000,"ESTIMATED","INTERVENTIONAL",[64],"NA","This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.",[67,68],"Perinatal Depression","Perinatal Anxiety",[70,71,72,73,74,75],"Depression","Anxiety","Perinatal","Prevention","mHealth","Implementation","NOT_YET_RECRUITING","2026-05-25",{"date":79,"type":80},"2026-05-29","ACTUAL",{"date":82,"type":61},"2026-05-30",{"date":84,"type":61},"2028-03-30",{"name":5,"class":6}]