[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583059":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":55,"collaborators":12,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":12,"enrollmentInfo":69,"targetDuration":12,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":36,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University Rovira i Virgili","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","NO_INTERVENTION","Participants in the control group will receive routine prenatal care as provided in the Spanish healthcare system. Standard care includes regular obstetric and midwifery follow-ups, screening for emotional distress during pregnancy, and referral to a mental health professional when clinically relevant symptoms of emotional disorders are detected. Emotional screening is integrated into prenatal visits to identify potential depressive, anxious, or other psychological symptoms, ensuring appropriate psychological or psychiatric support when necessary. This group will not receive the digital intervention and will serve as a comparator to evaluate the added benefits of the experimental intervention.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental group","EXPERIMENTAL","Participants in the experimental group will receive the same standard prenatal care as the control group, including routine emotional screening and referrals if necessary. Additionally, they will have access to a biopsychosocial, cognitive-behavioral digital intervention designed to promote gestational well-being and prevent emotional disorders during pregnancy. This intervention, delivered via a smartphone application, incorporates psychoeducation, cognitive restructuring, stress management techniques, progressive muscle relaxation, mindfulness, and guided visualization. It is structured into 10 interactive modules covering mental health promotion, prenatal attachment, childbirth preparation, and postpartum adaptation, aiming to enhance self-efficacy, emotional regulation, and maternal psychological resilience.",[18],"Other: Biopsychosocial Cognitive Behavioral Intervention",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Biopsychosocial Cognitive Behavioral Intervention","The study intervention is based on a biopsychosocial approach (considers the interaction between: biological factors such as physical health, fetal development and physiological changes; psychological factors such as stress management, emotions and thoughts; and social factors such as couple relationships, social support and the maternal role) with cognitive-behavioral strategies designed to promote comprehensive well-being during pregnancy and the postpartum. Techniques such as psychoeducation, reflection and self-observation, cognitive restructuring, problem solving, stress inoculation, progressive muscle relaxation, guided visualizations and mindfulness are applied.\n\nThe program consists of 10 modules focused on different areas: introduction to the study, mindfulness and breathing techniques, physical and mental health at different stages of pregnancy, fetal development and prenatal attachment, couple relationship, preparation for childbirth and postpartum, and care of the newborn.",[14],[25],{"name":26,"affiliation":5,"role":27},"Carmen Hernández Martínez, Doctor","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","+34675245881","carmen.hernandez@urv.cat",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Centre d'Atenció Primària Sant Pere","RECRUITING","Reus","Tarragona","43202","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],1.10687,41.15612,{"lat":46,"lon":45},[49,53],{"name":50,"role":30,"phone":51,"phoneExt":12,"email":52},"Cristina Rey Reñones, Doctor","93 482 41 24","crey.tgn.ics@gencat.cat",{"name":50,"role":54,"phone":12,"phoneExt":12,"email":12},"SUB_INVESTIGATOR",{"type":27,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Carmen Hernández Martínez","Doctor","100583059","effectiveness-of-an-online-biopsychosocial-intervention-to-improve-well-being-and-mental-health-during-pregnancy-100583059",false,"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,"FEMALE","18 Years",{"count":70,"type":71},228,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.",[77,78,79,80,81],"Prenatal Anxiety","Prenatal Depression","Wellbeing","Obstetrical Complications","Postnatal Depression",[83,84,85,86,87,88,89,90,91],"wellbeing","anxiety","depression","eHealth","maternal mental health","health promotion","cognitive behavioral intervention","randomized controlled trial","pregnancy","2025-07-14",{"date":94,"type":95},"2025-07-17","ACTUAL",{"date":97,"type":95},"2025-04-03",{"date":99,"type":71},"2026-09-30",{"name":5,"class":6},1]