[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perinatal-anxiety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perinatal-anxiety":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,49,77,106,133,153,194,221,244,265,288],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100645217","midwife-led-childbirth-review-and-psychological-outcomes-in-new-parents-100645217",false,"NCT07678801","Midwife-led Childbirth Review and Psychological Outcomes in New Parents","Effects of a Midwife-led Childbirth Review on Psychological Outcomes in New Parents","CROWN","Inclusion Criteria:\n\nPregnant women: Age ≥ 18 years; Singleton pregnancy; Fluency in Czech; Women can enter the study without a partner; Live birth after enrollment. Partners: Partner of an enrolled woman; Age ≥ 18 years; Planning on being present at childbirth; Fluency in Czech\n\nExclusion Criteria:\n\nPregnant women: Age \\\u003C 18 years; Multi-fetal pregnancy; Not being able to read and speak fluent Czech; A severe medical condition including significant pregnancy complications preventing participation in the intervention or assessments; Stillbirth or neonatal death; Infant admitted to intensive care for a prolonged or life-threatening condition; Acute psychiatric condition (suicidality, psychosis, manic episode, substance abuse). Partners: Age \\\u003C 18 years; Not being able to read and speak fluent Czech; Not planning on being present at childbirth \u002F after recruitment: not present at childbirth; A severe medical condition preventing participation in the intervention or assessments; Stillbirth or neonatal death; Infant admitted to intensive care for a prolonged or life-threatening condition; Acute psychiatric condition (suicidality, psychosis, manic episode, substance abuse)","ALL","18 Years",{"count":20,"type":21},1300,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this clinical trial is to support psychological well-being and facilitate adjustment to parenthood among postpartum mothers and fathers through a midwife-led childbirth review (MLCR). MLCR is a structured 45-60-minute postpartum intervention focused on processing and integration of the individual's childbirth experience, involving active listening, emotional support, and provision of information. In this study, the investigators will employ the MLCR intervention developed by Gamble and Creedy (2009) for women with traumatic birth experiences, adapted for use in the general population of new parents, including both mothers and fathers\u002Fpartners. This study will compare the effectiveness of three MLCR models - MLCR provided within the first postpartum week, MLCR provided at 6-8 weeks postpartum, and MLCR provided at both time points - with standard postpartum care and with each other.",[27,28,29],"Postpartum Depression (PPD)","Perinatal Anxiety","Postpartum Mental Health",[31,32,33,34,35],"Postpartum debriefing","Perinatal mental health","Midwife-led childbirth review","Parenting","Postpartum adjustment","NOT_YET_RECRUITING","2026-06-25",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":21},"2026-07-06",{"date":44,"type":21},"2028-07-15",{"name":46,"class":47},"Charles University, Czech Republic","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100628212","reaching-calm-a-digital-intervention-to-prevent-perinatal-anxiety-disorders-100628212","NCT07458698","Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders","Reaching Calm Pilot (K23)","Inclusion Criteria:\n\n* Receiving prenatal care at participating obstetric practice\n* Endorsed mild to moderate anxiety (GAD-7 score 5-15)\n* Currently pregnant (gestational age \\\u003C32)\n* Started Reaching Calm digital intervention, if in intervention group\n\nExclusion Criteria:\n\n* Not pregnant\n* Unable to participate in 60-minute interview\n* Unwilling to be audio recorded\n* GAD-7 \\\u003C5, or GAD-7≥15\n* Adults unable to consent (adults lacking capacity)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Non-English-speaking","FEMALE",{"count":58,"type":21},60,[24],"The goal of this clinical trial is to find out if a digital program called Reaching Calm can help prevent anxiety in women who are pregnant. The study will offer Reaching Calm at obstetric practices where participants receive prenatal care. The study focuses on people who may be at greater risk for experiencing anxiety during or after pregnancy. The main questions this study aims to answer are:\n\n* Is Reaching Calm easy to use and acceptable to both participants and healthcare professionals?\n* Does Reaching Calm help reduce risk for anxiety among participants?\n* Does personalizing the digital program help participants stay involved? Researchers will compare obstetric practices that offer Reaching Calm to those providing usual care.\n\nParticipants will:\n\n* Receive text messages and use a web-based platform for learning about anxiety and coping strategies\n* Respond to surveys about their experiences and symptoms\n* Some will take part in interviews and focus groups to share their views\n* Healthcare professionals will receive training on how to support the program The study will monitor how many people join, stay involved, and how the program affects their well-being. The results will help prepare for a larger study that could lead to wider use of Reaching Calm across the country.",[28,62,63],"Anxiety Sensitivity","Perinatal Depression",[65,66,32,67,68],"Perinatal anxiety","Obstetric care","Digital mental health","Engagement","2026-06-10",{"date":71,"type":40},"2026-06-12",{"date":39,"type":21},{"date":74,"type":21},"2029-08-31",{"name":76,"class":47},"University of Massachusetts, Worcester",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100638984","virtual-forest-based-mindfulness-for-perinatal-mental-health-100638984","NCT07606248","Virtual Forest-Based Mindfulness for Perinatal Mental Health","Evaluating the Effects of an Integrated Virtual Forest Environment and Mindfulness-Based Intervention on Mental Health in Perinatal Women","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older\n* Gestational age below 25 weeks at recruitment\n* Able to communicate in Chinese and provide informed consent\n* Willing to participate in the study and complete follow-up assessments\n\nExclusion Criteria:\n\n* Diagnosed epilepsy, photosensitive epilepsy, or other neurological disorders\n* Severe anxiety, depression, or other psychiatric disorders currently receiving intensive treatment\n* History of severe adverse reactions to virtual reality devices, including severe dizziness, nausea, or visual discomfort\n* Inability to participate in mindfulness or VR intervention proceduresriteria:\n\nExclusion Criteria:\n\n\\-",true,{"count":86,"type":21},100,[24],"Perinatal anxiety and depression are common mental health concerns that may negatively affect maternal well-being, infant development, and family functioning. Mindfulness-based interventions have shown beneficial effects on reducing psychological distress during pregnancy; however, maintaining attention and engagement during mindfulness practice may be challenging for some pregnant women.\n\nThis randomized controlled trial aims to evaluate the feasibility and effectiveness of an integrated virtual forest environment and mindfulness-based intervention for improving mental health in perinatal women. Pregnant women between 20 and 24 weeks of gestation will be randomly assigned to either an experimental group receiving virtual reality (VR)-based forest mindfulness intervention or a control group receiving conventional mindfulness intervention.\n\nBoth groups will participate in a 9-week mindfulness program and receive app-based mindfulness practice. The experimental group will additionally receive immersive VR forest-based mindfulness sessions during prenatal visits. Outcomes including anxiety, depression, mindfulness awareness, physiological indicators, and intervention acceptability will be assessed during pregnancy and postpartum follow-up.",[28,63,90],"Maternal Mental Health",[92,93,94,32,95],"Virtual reality","Mindfulness","Forest therapy","Pregnancy","2026-05-26",{"date":98,"type":40},"2026-05-29",{"date":100,"type":21},"2026-05-25",{"date":102,"type":21},"2027-12-31",{"name":104,"class":47},"National Taiwan University Hospital",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":84,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100637378","effectiveness-and-implementation-of-a-personalized-mhealth-intervention-for-the-universal-prevention-of-maternal-perinatal-mental-disorders-100637378","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",{"count":115,"type":21},3000,[24],"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.",[63,28],[120,121,122,123,124,125],"Depression","Anxiety","Perinatal","Prevention","mHealth","Implementation",{"date":98,"type":40},{"date":128,"type":21},"2026-05-30",{"date":130,"type":21},"2028-03-30",{"name":132,"class":47},"University of Seville",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":84,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":151,"leadSponsor":152,"locationsCount":4},"100639051","feasibility-and-implementation-of-early-referral-in-perinatal-mental-health-100639051","NCT07609550","Feasibility and Implementation of Early Referral in Perinatal Mental Health","Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study","e-Perinatal-Re","Inclusion Criteria:\n\n* Pregnant and postpartum women enrolled in the main e-Perinatal trial, indicating the presence of a depressive or anxiety disorder with CIDI.\n* Access to smartphone and internet\n* Able to write and read in Spanish\n\nExclusion Criteria:\n\n* None beyond those defined in the main trial",{"count":115,"type":21},[24],"This study is part of the e-Perinatal project and is embedded within the main cluster randomized trial. The primary aim is to evaluate the feasibility, acceptability, and preliminary effectiveness of an early diagnosis detection and referral strategy to specialized mental health services within routine maternal care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.",[63,28],[120,121,122,146,124,125],"Referral","2026-05-19",{"date":149,"type":40},"2026-05-27",{"date":128,"type":21},{"date":130,"type":21},{"name":132,"class":47},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":171,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":105},"100576849","pathways-to-perinatal-mental-health-equity-100576849","NCT06790641","Pathways to Perinatal Mental Health Equity","Pathways","Inclusion Criteria for perinatal care setting team members:\n\n* Be employed by a participating perinatal care setting in a clinical role (including as an obstetrician-gynecologist, midwife, nurse practitioner, a nurse, a navigator, or administrative staff member who implemented the respective intervention during the study period).\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for peer mentors:\n\n* Have completed PSI training to be a peer mentor\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for perinatal individuals:\n\n* Have received perinatal care at a study partnering perinatal care setting during the study period\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English or Spanish\n\nExclusion Criteria:\n\nAn individual who does not meet the inclusion criteria listed above will be excluded from participation in this study. There are no additional exclusion criteria.","70 Years",{"count":162,"type":21},1270,[24],"Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, \"Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?\" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.",[28,63,166,167,168,169,170],"Social Determinants of Health (SDOH)","Peer Support","Obstetric Care","Substance Use Disorder (SUD)","Perinatal Depression, Substance Use",[172,173,174,175,176,177,178,179,180,181,182,183,184],"implementation strategies","obstetric care","perinatal mental health","perinatal anxiety","perinatal depression","perinatal mood disorders","qualitative study","focus groups","mixed methods","perinatal care","peer mentors","peer support","healthcare-community partnership","RECRUITING","2026-04-14",{"date":188,"type":40},"2026-04-20",{"date":190,"type":40},"2025-12-05",{"date":192,"type":21},"2030-10-01",{"name":76,"class":47},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":105},"100508223","feasibility-and-acceptability-of-a-novel-cognitive-behavioral-skills-mobile-app-for-pregnant-and-postpartum-individuals-100508223","NCT05897619","Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals","Pilot Trial Assessing Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for a Perinatal Population","Inclusion Criteria:\n\n* Female, Trans-male, non-binary, gender expansive, or gender questioning gestational carriers of pregnancy\n* Currently pregnant or up to 12 months postpartum\n* 18 years or older\n* English proficiency\n* Have access to a smartphone or other mobile device capable of receiving Short Message Service (SMS) pushes and complete Qualtrics surveys and App modules\n* Be available to speak by phone or secure video-conference platform at points throughout the study.\n\nExclusion Criteria:\n\n* Safety concerns at the time of enrollment, including, but not limited to, a response \\>0 on the EPDS question 10 or reported suicidal or self-harm thoughts or behaviors within one year of enrollment\n* Current substance use disorder\n* History of a bipolar or psychotic disorder, or current symptoms of psychosis or mania.",{"count":202,"type":21},75,[24],"This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum individuals experiencing difficulties with mood, anxiety, or stress. Participants will complete the 12-module app to learn evidence-based strategies previously shown to help manage mood and anxiety. Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures. The study investigators hypothesizes that participants will find content to be helpful in developing skills to manage anxiety and mood difficulties during the perinatal period, and that the app interface, session structure, and pacing will be acceptable and feasible for this population. It is further hypothesized that increased Maya Perinatal Cognitive Behavioral Skills App use, engagement, and satisfaction will be associated with lower self-reported anxiety and mood symptoms.",[28,63],[122,95,207,208,209,210,211],"Postpartum","Perinatal Mood and Anxiety Disorders","Cognitive Behavioral Therapy","Mobile App","mobile Health (mHealth)","2026-02-24",{"date":214,"type":40},"2026-02-27",{"date":216,"type":40},"2023-09-19",{"date":218,"type":21},"2027-02",{"name":220,"class":47},"Weill Medical College of Cornell University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":84,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":105},"100609667","testing-doula-link-a-multi-component-intervention-to-improve-perinatal-mental-health-100609667","NCT07217561","Testing \"Doula Link\", a Multi-Component Intervention to Improve Perinatal Mental Health","Doula Link for Perinatal Mental Health - Trial","Doula Link","Inclusion Criteria:\n\n* For doulas: currently providing prenatal or postpartum support to at least one client; plant to provide prenatal or postpartum support to at least three clients in the next six months; work in Massachusetts; did not participate in development of the intervention; available to participate in in-person training; English language fluency\n* For clients: Pregnant or no more than 12 weeks postpartum at enrollment; served by one of the 30 study doulas; live in, and plan to give birth in Massachusetts; fluency in either English or Spanish\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria",{"count":230,"type":21},90,[24],"Doulas are trained individuals who offer informational, emotional, and physical support to their pregnant, birthing, and postpartum clients. The goal of this clinical trial is to learn if a new intervention (called \"Doula Link\") is feasible to implement and acceptable to both doulas and their clients. The main questions it aims to answer are:\n\n* Is Doula Link feasible to implement and acceptable to doulas and their clients?\n* What are the preliminary differences in depression and anxiety between individuals working with doulas who received Doula Link compared to those who did not receive Doula Link?\n\nResearchers will compare \"Doula Link\" to usual doula practice to see if Doula Link is feasible and has potential to improve mental health outcomes in postpartum individuals.\n\nDoulas will be randomly assigned to either receive \"Doula Link\" or continue with their practice as usual.\n\nParticipating doulas assigned to Doula Link will receive training mental health and implementing an intervention called \"Our Babies and Us\"; receive access to a toolkit; receive access to perinatal psychiatrists and referral specialists for consultations; receive access to a support group\n\nAll participating doulas will be invited to complete surveys about their experience with Doula Link (if assigned to that group) and their experience providing care for their clients.\n\nAll participating clients (pregnant and postpartum individuals) will be invited to complete surveys about their experiences with their doulas, their own mental health, and their experiences with the health system.",[63,28],[235,32,120],"Doulas","2025-10-21",{"date":238,"type":40},"2025-10-22",{"date":236,"type":40},{"date":241,"type":21},"2027-06",{"name":243,"class":47},"Beth Israel Deaconess Medical Center",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":105},"100565340","feasibility-study-and-pilot-hybrid-effectiveness-implementation-trial-for-the-universal-prevention-of-maternal-perinatal-mental-disorders-as-normalized-routine-practice-e-perinatal-pilot-100565340","NCT06640907","Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)","Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)","Inclusion criteria for mothers:\n\n* Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers\n* Must be pregnant for at least 16 weeks or have given birth within the last 5 months at the time of enrollment\n* Must be at least 18 years old\n* Must have access to a mobile phone and internet connection\n* Must be able to read, write, and understand Spanish\n* Must have a personal email account\n\nInclusion criteria for partners (or significant others):\n\n* Must receive an invitation to participate from a woman already enrolled in the study\n* Must be at least 18 years old\n* Must have access to a mobile phone and internet connection\n* Must be able to read, write, and understand Spanish\n* Must have a personal email account\n\nExclusion criteria for mothers:\n\n* Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview\n* Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition\n\nExclusion criteria for partners (or significant others):\n\n* There are no exclusion criteria for partners",{"count":252,"type":21},96,[24],"This study is part of the e-Perinatal project, funded by the European Research Council. This research project will follow the first three phases recommended by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions (Skivington et al., 2021).\n\nThe primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.",[63,28],[120,121,122,257,123,124],"Well-being","2025-05-02",{"date":260,"type":40},"2025-05-07",{"date":258,"type":40},{"date":263,"type":21},"2025-12",{"name":132,"class":47},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":105},"100493886","brief-cognitive-behavioural-therapy-for-insomnia-versus-sleep-hygiene-for-sleep-difficulties-in-early-pregnancy-100493886","NCT05710991","Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy","A Randomized Controlled Trial Examining the Impact of a Brief, Proactive, Cognitive Behavioural Therapy Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy","Inclusion Criteria:\n\n1. ≥18 years\n2. First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early\u002Fproactive benefit of sleep intervention.\n3. Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index)\n4. Fluent in English.\n\nExclusion Criteria:\n\n1. Severe depression\u002Factive suicidal ideation or psychotic\n2. Unstable general medical condition\n3. Current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration\n4. a sleep disorder other than insomnia (e.g., restless leg syndrome).","45 Years",{"count":274,"type":21},102,[24],"Pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. Research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy. Currently, there are two main non-medical treatments for sleep difficulties available. The first, cognitive behavioural therapy (CBT), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. In addition, shortened sessions of CBT for insomnia have also been found to successfully reduce sleep difficulties. The second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. The present study will compare the effectiveness of a CBT for insomnia group workshop to a Sleep Hygiene group workshop.",[278,28,63],"Sleep Disturbance","2024-09-28",{"date":281,"type":40},"2024-10-01",{"date":283,"type":40},"2023-08-10",{"date":285,"type":21},"2025-09",{"name":287,"class":47},"St. Joseph's Healthcare Hamilton",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":272,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100478498","phase-3-cognitive-behavioural-therapy-versus-psychoeducation-for-perinatal-anxiety-100478498","NCT05510752","Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety","Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Women 18 and older that are pregnant or between 0-12 months postpartum;\n2. Principal diagnosis of an anxiety disorder as per the Mini International Neuropsychiatric Interview for DSM-5 (version 7.0.2) with or without comorbid depression;\n3. No concurrent psychological treatment;\n4. Not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; and b) medications remain stable throughout the study;\n5. Fluent in English, minimal grade 8 reading level.\n\nExclusion Criteria:\n\n1. Severe depression\u002Fsuicidality requiring acute intervention;\n2. Women with psychotic or current substance use disorders,\n3. medication changes in dose or type or less than 5\u002F6 sessions complete (will continue with treatment but be excluded from the study).",{"count":296,"type":21},216,[298],"PHASE3","Anxiety during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a barrier to receiving effective treatment for many women. As such, the present single-blind, randomized controlled trial seeks to evaluate whether group-based cognitive behavioural therapy, the gold-standard psychological treatment for anxiety disorders in the general population, effectively treats perinatal anxiety symptoms when compared to a psychoeducation group, which is currently the most commonly prescribed non-medication-based treatment for perinatal distress.",[28],"2022-08-19",{"date":303,"type":40},"2022-08-22",{"date":305,"type":21},"2022-09-01",{"date":307,"type":21},"2026-09-01",{"name":287,"class":47}]