[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prenatal-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prenatal-depression":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100604612","technology-supported-mindfulness-for-prenatal-depression-and-mental-health-related-quality-of-life-in-a-resource-limited-environment-100604612",false,"NCT07151781","Technology Supported Mindfulness for Prenatal Depression and Mental Health-related Quality of Life in a Resource-Limited Environment","Technology Supported Mindfulness for Prenatal Depression and Mental Health-related Quality of Life: Research Protocol for Randomized Controlled Trial in a Resource-Limited Environment","Inclusion Criteria:\n\n* Pregnant women who lived in Jimma City for at least six months\n* Women with a gestational age between 12 and 28 weeks,\n* Women who scored EPDS ≥ 13,\n* Willing to participate for eight consecutive weeks,\n* Able to attend the health center three times per week and gave consent to be followed up by study supervisors and data collectors\n\nExclusion Criteria:\n\n* Having been diagnosed with mental health disorders or eating disorders,\n* Active substance use,\n* EPDS item 10 score ≥1 or total EPDS score \\>19,\n* Currently receiving pharmacological or psychotherapeutic treatment,\n* Regularly practice meditation,\n* Severely ill,\n* Has active pregnancy-related complications that could interfere with attending the mindfulness exercise, or neurological conditions such as epilepsy or seizures","FEMALE","15 Years","49 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if a video-guided mindfulness intervention can improve prenatal depression symptoms, improve mental health-related quality of life, reduce the risk of maternal postpartum depression and paternal postpartum depression, and improve neonatal birth outcomes in a resource-constrained setting. This clinical trial will be conducted in pregnant women. The main questions it aims to answer are:\n\n* Can video-guided mindfulness intervention be effective for prenatal depression treatment as compared to routine care?\n* Is there a dose-response relationship between the length of a video-guided mindfulness intervention and a reduction in prenatal depression symptoms?\n* Does a video-guided mindfulness intervention improve mental health-related quality of life more effectively than routine care?\n* What is the impact of intervention duration on the effectiveness of a video-guided mindfulness intervention for improving mental health-related quality of life?\n* Can a video-guided mindfulness intervention during pregnancy lead to improved neonatal birth outcomes compared to standard care?\n* Can a video-guided mindfulness intervention during pregnancy reduce the risk of developing prenatal depression compared to routine care?\n* Can the treatment of maternal prenatal depression through a video-guided mindfulness intervention reduce the risk of paternal postpartum depression? Researchers will compare the intervention group with a group of pregnant women who screen positive for prenatal depression but continue to receive only routine antenatal care, in order to evaluate differences in prenatal depression symptoms, improvements in mental health-related quality of life, reductions in the risk of maternal and paternal postpartum depression, and improvements in neonatal birth outcomes.\n\nParticipants (the intervention group) will receive a video-guided mindfulness intervention that they will listen to for eight weeks at their nearest health center three times a week.",[27,28,29,30],"Prenatal Depression","Mental Health Related Quality of Life","Maternal Postpartum Depression","Paternal Postpartum Depression",[32,33,34,35,36,37],"mHealth","mindfulness","prenatal depression","randomized controlled trial","health technology","RCT","NOT_YET_RECRUITING","2025-08-25",{"date":41,"type":42},"2025-09-03","ACTUAL",{"date":44,"type":21},"2025-11-01",{"date":46,"type":21},"2025-12-31",{"name":48,"class":49},"Bekelu Teka Worku","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":50},"100583059","effectiveness-of-an-online-biopsychosocial-intervention-to-improve-well-being-and-mental-health-during-pregnancy-100583059","NCT06871397","Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy","Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy: A Randomized Clinical Trial","BienGestar","Inclusion Criteria:\n\n* Pregnant women\n* Pregnancy of less than 15 weeks of gestation\n* More than 18 years old age\n* Able to read, write, and understand Spanish\n* In possession of a smartphone\n* Able to manage smartphone apps\n* Have signed a written informed consent document\n\nExclusion Criteria:\n\n* Having a high-risk pregnancy that entails transfer to another specialized health centre\n* Having diagnosis of disease that may affect the central nervous system, such as brain pathology or traumatic brain injury\n* Having other psychiatric diagnosis or acute psychiatric illness, such as substance dependence or abuse, a presence of schizophrenia or other psychotic disorders or risk for suicide\n* To be under psychopharmacological medication or under psychopharmacological treatment.",true,"18 Years",{"count":62,"type":21},228,[24],"This study aims to develop and implement a preventive intervention through a mobile application to help pregnant women feel better emotionally and cope with the changes of pregnancy in a more positive way. The idea is to offer practical and accessible tools that allow them to better manage stress, emotions and preparation for motherhood. The intervention proposed in this study is based on psychological strategies that have proven to be effective, such as relaxation exercises, techniques to manage stress and strategies to improve mood, strengthen the relationship with the partner and foster the bond with the baby before its birth.\n\nThe application is designed to accompany pregnant women from the beginning of pregnancy to the postpartum period. It has different programs that include weekly activities on various important topics, such as physical health care, emotional management, connection with the baby during pregnancy, preparation for childbirth and the first months of the newborn's life.\n\nTo evaluate the effectiveness of this tool, a study will be carried out with pregnant women treated by the Catalan Health Service. Participants will be randomly assigned to one of two study groups: the experimental group (in which participants, in addition to the usual medical care offered during pregnancy, will have access to the programs and activities of the app organized in a weekly plan of 5 activities and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum) or the control group (in which participants will receive the usual medical care offered during pregnancy, but will not have access to the programs and activities of the app and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum).\n\nWomen who use the app are expected to experience greater emotional well-being and a lower risk of developing mental health problems during pregnancy. In addition, they may feel more prepared for motherhood, take better care of their health, have a more positive birth experience and a lower risk of postpartum depression. These women are also expected to develop a stronger bond with their baby and adapt better to the new stage of motherhood.",[66,27,67,68,69],"Prenatal Anxiety","Wellbeing","Obstetrical Complications","Postnatal Depression",[71,72,73,74,75,76,77,35,78],"wellbeing","anxiety","depression","eHealth","maternal mental health","health promotion","cognitive behavioral intervention","pregnancy","RECRUITING","2025-07-14",{"date":82,"type":42},"2025-07-17",{"date":84,"type":42},"2025-04-03",{"date":86,"type":21},"2026-09-30",{"name":88,"class":49},"University Rovira i Virgili"]