[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anxiety-in-pregnancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anxiety-in-pregnancy":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100589084","preventing-maternal-mood-anxiety-and-trauma-symptoms-after-cesarean-delivery-100589084",false,"NCT06949813","Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery","Inclusion Criteria:\n\n* Pregnant Patients at 22-37 weeks gestation\n* Single or multiple gestation\n* Nulliparous or multiparous (with prior vaginal or cesarean delivery)\n* Antepartum admission for at least 3 days\n* High-risk pregnancy due to maternal\u002Ffetal comorbidities\n* Anticipated cesarean delivery at the University of Colorado\n\nExclusion Criteria:\n\n* Lack of capacity to consent\n* Medical factors prohibiting participation in the intervention as determined by the inpatient obstetric medical team.\n* Anticipated cesarean within 7 days of enrollment","FEMALE",{"count":17,"type":18},80,"ESTIMATED","INTERVENTIONAL",[21],"NA","Perinatal mental health disorders are the most prevalent perinatal comorbidity and are associated with the primary cause of maternal mortality in the United States (US) - suicide. Diagnosis of a high-risk pregnancy and cesarean delivery (CD) are both associated with increased risk for perinatal mood, anxiety, and trauma symptoms (PMATS). There is a deficit in resources and access to mental health treatment for pregnant patients, with some treatments being cost-prohibitive and requiring multiple sessions. Additionally, current approaches to addressing PMATS are reactive rather than preventive. There is evidence in the non-obstetric population that single-session cognitive behavioral therapy interventions targeting anxiety sensitivity (fear of fear) can prevent the development of anxiety and trauma symptoms when individuals are exposed to trauma. The investigators developed a low-cost, 1-hour, single-session prevention intervention that included psychoeducation about anxiety sensitivity, coupled with a brief exposure to the operating room environment and CD procedures. To revise the implementation plan and intervention (CARE: Communication, Agency, Readiness, Empowerment for cesarean delivery \\[CD\\]) for use in large L\\&D units with a broader population of patients, a fully powered multisite randomized control trial (RCT) is needed. Before initiating such a trial, work needs to be done to modify the intervention and implementation through a process of iterative refinement to enhance the acceptability, appropriateness, and feasibility of implementation in L\\&D units across the country, as well as its efficacy at engaging with the target mechanism (anxiety sensitivity). Using a logic model to guide the iterative refinement process through fast feedback loops and an atmosphere of co-creation, study investigators will gather critical input from stakeholders (individuals with lived experiences, community partners, front-line clinicians, and hospital staff) via 12 workgroups, 12 user-testing design sessions, and repeated engagement with a steering council. Following this refinement process, a treatment development pilot RCT at a large L\\&D unit will assess the efficacy of CARE for CD by probing engagement with the target mechanism, as well as assess the feasibility of implementation. Finally, the updated logic model and pilot trial results will inform the development of a protocol for a multisite RCT through engagement with expert consultants in a community engagement studio and further feedback from the steering council.",[24,25],"Anxiety in Pregnancy","Mood Disorder Due to Specified Medical Condition",[27,28,29,30],"perinatal mood and anxiety disorders","cesarean delivery","Single session immersive intervention","Randomized Controlled Trial","RECRUITING","2026-03-19",{"date":34,"type":35},"2026-03-23","ACTUAL",{"date":37,"type":35},"2025-10-13",{"date":39,"type":18},"2027-04-30",{"name":41,"class":42},"University of Colorado, Denver","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":15,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":19,"phases":54,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100544100","trueblue-clinical-study---investigating-the-use-of-a-mobile-phone-app-trueblue-for-monitoring-depression-and-anxiety-100544100","NCT06364488","TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety","Inclusion Criteria:\n\n\\- 18 years or older\n\n* Fluent in spoken and written English\n* Has capacity to provide consent\n* At least 12 weeks pregnant or less than 12 weeks postpartum\n* Access to internet connectivity\n* Access to a compatible smart phone device (for up to 10 participants, where needed through not having a personal device, this access may be provided through the study team).\n* Has a current GP within Nottinghamshire\n\nExclusion Criteria:\n\n* ● Current clinically diagnosed psychiatric disorder other than depression\n\n  * Previous history of a clinically diagnosed psychiatric disorder, other than depression and generalised anxiety disorder (including previous Psychosis, Bipolar Disorder, Personality Disorder, Substance Abuse Disorders, Eating Disorders)\n  * Clinical diagnosis of an Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Parkinson's Disease or other current Neurological Disorder.",true,"18 Years",{"count":53,"type":18},125,[21],"This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period.",[57,58,24,59,60,61],"Depression","Depression, Postpartum","Anxiety","Anhedonia","Perinatal Depression",[57,59,63],"Perinatal","2025-09-16",{"date":66,"type":35},"2025-09-19",{"date":68,"type":35},"2024-10-01",{"date":70,"type":18},"2026-12-30",{"name":72,"class":73},"BlueSkeye AI","INDUSTRY",2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":51,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":19,"phases":86,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100529540","heartgps-a-study-exploring-the-effects-of-a-psychological-intervention-for-parents-and-their-babies-after-prenatal-cardiac-diagnosis-100529540","NCT06175104","HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis","HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Effects of a Prenatally-Delivered Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease","HeartGPS","Inclusion Criteria\n\n1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).\n2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation.\n3. Singleton pregnancy.\n4. Pregnant person is planning to continue with the pregnancy.\n5. Pregnant person is able to participate and complete study assessments in English.\n\nExclusion Criteria\n\n1. Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).\n2. Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.\n3. Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.\n4. Parent with a moderate to severe intellectual disability.\n5. Parent age \\\u003C18 years.\n6. Surrogate for pregnancy.\n\nPrenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.","ALL",{"count":85,"type":18},50,[21],"Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.",[89,24,58,90,91],"Heart Defects, Congenital","Trauma, Psychological","Neurodevelopmental Disorders",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"Congenital Heart Disease","Prenatal","Mental Health","Neurodevelopment","Neurobehavior","Fetal Cardiology","Psychological Intervention","Mother-Infant Attachment","Mother-Infant Bonding","Medical Traumatic Stress","Neuroimaging","Brain Development","Fetal Neuroimaging","Perinatal Mental Health","Medical Psychology","2025-07-16",{"date":110,"type":35},"2025-07-20",{"date":112,"type":18},"2025-07-14",{"date":114,"type":18},"2027-12",{"name":116,"class":42},"Children's Hospital Medical Center, Cincinnati",4]