[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perinatal-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perinatal-depression":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,48,72,100,128,148,172,212,242,267,294,316,341,364,384,410,439,467,489,514,534,556,581,602,635],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"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":4},"100628212","reaching-calm-a-digital-intervention-to-prevent-perinatal-anxiety-disorders-100628212",false,"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","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29],"Perinatal Anxiety","Anxiety Sensitivity","Perinatal Depression",[31,32,33,34,35],"Perinatal anxiety","Obstetric care","Perinatal mental health","Digital mental health","Engagement","NOT_YET_RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-12","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2029-08-31",{"name":46,"class":47},"University of Massachusetts, Worcester","OTHER",{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100637526","parents-and-babies-pilot-100637526","NCT07607613","Parents and Babies Pilot","Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention","PAB","Inclusion Criteria:\n\n* self-identify as LGBTQ+\n* 18 years old or older\n* live in the USA or territories\n* speak and understand English\n* Currently pregnant or within one year of childbirth\n* Endorse current mild depressive symptoms or risk factors for postpartum depression\n\nExclusion Criteria:\n\n* Are unable to consent\u002Fhave impaired decision making capacity\n* Have current active suicidal or homicidal ideation, active psychosis, or current mania\n* Are currently experiencing a severe depressive episode\n* Do not have audio and\u002For video capacity for attending group sessions remotely.",{"count":57,"type":21},16,[24],"The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring\u002Funderstanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.",[29,61],"Postpartum Depression (PPD)","2026-06-01",{"date":64,"type":40},"2026-06-04",{"date":66,"type":21},"2026-06",{"date":68,"type":21},"2027-04",{"name":70,"class":47},"Northwestern University",1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":71},"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":81,"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.",[27,29,85],"Maternal Mental Health",[87,88,89,33,90],"Virtual reality","Mindfulness","Forest therapy","Pregnancy","2026-05-26",{"date":93,"type":40},"2026-05-29",{"date":95,"type":21},"2026-05-25",{"date":97,"type":21},"2027-12-31",{"name":99,"class":47},"National Taiwan University Hospital",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":79,"sex":108,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"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","ALL",{"count":110,"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.",[29,27],[115,116,117,118,119,120],"Depression","Anxiety","Perinatal","Prevention","mHealth","Implementation",{"date":93,"type":40},{"date":123,"type":21},"2026-05-30",{"date":125,"type":21},"2028-03-30",{"name":127,"class":47},"University of Seville",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":147,"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":110,"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.",[29,27],[115,116,117,141,119,120],"Referral","2026-05-19",{"date":144,"type":40},"2026-05-27",{"date":123,"type":21},{"date":125,"type":21},{"name":127,"class":47},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":71},"100638959","health-and-response-digital-markers-for-outcomes-in-perinatal-depression-treatment-study-100638959","NCT07577947","Health And Response: Digital Markers for Outcomes in Perinatal Depression Treatment Study","HARMONY","Inclusion Criteria:\n\n* At least 18 years of age\n* Able to read and communicate in English\n* Between 28 weeks pregnant and 12 weeks postpartum\n* Moderate-to-severe depression, as defined by Edinburgh Postnatal Depression Scale (EPDS) score ≥11\n* Not currently seeing a provider for mental health care\n* Own functioning iOS smartphone (iPhone 11 or newer, iOS 18 or newer) with access to reliable data plan and Wifi)\n* Able to read and understand a written informed consent form\n* Willingness to participate in treatment through the study and follow all study procedures, including providing HIPAA Authorization for research, installing a study app on personal iPhone, and wearing the provided Apple Watch for at least 20 hours every day in the first four weeks of the study (including while sleeping)\n\nExclusion Criteria:\n\n* Currently receiving treatment by a therapist or a psychiatrist\n* Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months)\n* Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded\n* Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)\n* Neurological conditions\n* Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)\n* Cognitive impairment (e.g., developmental disability, dementia)\n* Previously participated in the UCLA Depression Grand Challenge \"New Moms Mood Tracking \\& Wellbeing Study\" (IRB #20-001924)",{"count":156,"type":21},250,[24],"The purpose of this study is to determine if the addition of digital sensing data collected from phones and watches during the early stages of perinatal depression (PND) treatment can better predict treatment outcomes than using self-reported symptoms alone.STAND for PND: The UCLA Depression Grand Challenge (DGC) has previously developed a technology-assisted, scalable therapy system called STAND (Screening and Treatment for ANxiety and Depression) for perinatal depression (PND) and has demonstrated in an initial randomized clinical trial that this treatment intervention to be as effective as psychiatrist delivered care for PND. In this study, the investigators will administer STAND for PND for up to 12 weeks as part of study participation. There will be no comparison between our treatment intervention and a treatment as usual condition, as this is not a trial of efficacy. In the STAND for PND treatment model, women with moderate symptoms will be routed to coach-guided, digital cognitive behavioral therapy (CBT) tailored to PND, which has been demonstrated to be an effective treatment approach for PND. Women with severe depression or suicidality will be routed to clinician delivered CBT, with pharmacotherapy as needed, with both CBT and pharmacotherapy demonstrated to be effective treatment approaches for PND. Symptoms will be regularly monitored throughout the intervention period. Digital Sensing in Depression: The DGC also has substantial experience in large-scale longitudinal digital sensing studies, and experience identifying associations between self-report or clinical ratings of depressive symptoms and digital sensing features, including in pregnant and postpartum women. Digital Sensing in a STAND for PND study: In our previous STAND for PND study, the investigators did not include digital sensing. In this next phase of our research program, the investigators will collect digital sensing data from phones and watches during the first four weeks of study participation. The investigators will enroll up to 250 women during their last trimester or who are in the postpartum period to participate in the 12-week study, which includes treatment provided through the STAND for PND program of care and during which the investigators will obtain 4-weeks of digital sensing data.The investigators will be testing whether behaviors measures through digital sensing (i.e., digital features) in combination with self-reported depression symptoms will better predict treatment outcomes than the self-reported depression symptoms alone. The investigators are testing the hypothesis that prospective longitudinal assessments using digital devices will enhance our ability to predict outcomes of STAND-PND.This project is part of a larger program of research that aims to improve clinical decision-making for PND by establishing a clinical care model for PND that fully integrates digital sensing with digital therapy. An additional objective of this program of research is to target low-income mothers from populations that have had limited access to mental healthcare, given that this population is particularly vulnerable to the impact of PND.",[115,29],[161,162],"depression","perinatal depression","2026-05-04",{"date":165,"type":40},"2026-05-11",{"date":167,"type":21},"2026-05-05",{"date":169,"type":21},"2027-05-01",{"name":171,"class":47},"University of California, Los Angeles",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":108,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":190,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":71},"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":181,"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.",[27,29,185,186,187,188,189],"Social Determinants of Health (SDOH)","Peer Support","Obstetric Care","Substance Use Disorder (SUD)","Perinatal Depression, Substance Use",[191,192,193,194,162,195,196,197,198,199,200,201,202],"implementation strategies","obstetric care","perinatal mental health","perinatal anxiety","perinatal mood disorders","qualitative study","focus groups","mixed methods","perinatal care","peer mentors","peer support","healthcare-community partnership","RECRUITING","2026-04-14",{"date":206,"type":40},"2026-04-20",{"date":208,"type":40},"2025-12-05",{"date":210,"type":21},"2030-10-01",{"name":46,"class":47},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100632556","efficacy-of-yoga-based-intervention-in-improving-mother-child-bonding-in-maternal-depression-100632556","NCT07515222","Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression","Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression - A Randomised Controlled Trial","Inclusion Criteria:\n\n* • Mothers aged 19 to 45 years presenting with an index depressive episode with onset either antenatally or within 12 months following childbirth and having a living child aged 0 to 28 months at time of enrolment\n\n  * Edinburgh Postnatal Depression Scale (EPDS) score of 13 or above3\n  * Willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* • Severe mental health conditions including psychotic features\n\n  * Active suicidal ideation or infanticidal ideas\n  * Active substance dependence (excluding nicotine)\n  * Unstable medical condition\n  * Extreme physical limitation precluding yoga participation\n  * Visual or auditory impairment","19 Years","45 Years",{"count":222,"type":21},52,[24],"Perinatal depression (PND), defined as a depressive episode occurring from the antenatal period through 12 months following childbirth, has a reported prevalence of 12-22%, with higher rates in low- and middle-income countries (LMICs) including India. PND has a multifaceted and detrimental impact on both the mother and the child during a critical window of the child's emotional, cognitive, and physical development. Mother-infant bonding - the affective relationship that develops between a mother and her infant - is significantly impaired by maternal depression. Impaired bonding leads to poor antenatal attachment, earlier cessation of breastfeeding, risk of child maltreatment and neglect, and diminished reciprocal emotional and cognitive growth in the infant. The maternal brain undergoes significant neurobiological adaptations during the perinatal period to facilitate recognition of infant emotional cues, reward-driven bonding experiences, and reciprocal emotional responses. These include changes in oxytocin signalling, cortisol regulation, and functional connectivity of brain regions involved in maternal behaviour. Perinatal depression disrupts these neurobiological processes. Yoga-based interventions offer a safe, cost-effective, culturally acceptable, non-pharmacological approach. Yoga has demonstrated efficacy in improving depression and anxiety in perinatal populations. Its mechanisms include modulation of the HPA axis, reduction of cortisol, enhancement of oxytocin release, and promotion of mindful interoceptive awareness - directly relevant to the neurobiological disruptions in PND. This randomised controlled trial evaluates the efficacy of a structured 3-week bedside yoga intervention as an add-on to treatment as usual in improving mother-infant bonding scores, depression scores, and peripheral oxytocin and cortisol levels in mothers with perinatal depression. The study additionally explores the baseline neural correlates of mother-infant bonding using Event Related Potentials (ERP) and functional MRI (fMRI) of the brain.",[29,226,227],"Postpartum Depression","Mother-Infant Bonding Disorder",[229,230,231,232],"Perinatal depression","Postpartum depression","Mother-infant bonding","Yoga","2026-03-31",{"date":235,"type":40},"2026-04-07",{"date":237,"type":21},"2026-04-15",{"date":239,"type":21},"2027-05-15",{"name":241,"class":47},"All India Institute of Medical Sciences",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":79,"sex":108,"minAge":249,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":71},"100500765","gestational-diabetes-and-perinatal-depression-an-intervention-program-100500765","NCT05800509","Gestational Diabetes and Perinatal Depression: an Intervention Program","Gestational Diabetes and Depression in Pregnancy and the Postpartum Period Among Women: A Longitudinal Study and Interventive Program","Inclusion Criteria:\n\n* 1\\. The diagnosis of gestational diabetes mellitus.\n* 2\\. No any history of disease\\* before the pregnancy or do have history of disease\\* without taking any medicines. (\\*disease, eg. hypertension, diabetes mellitus, hyperthyroidism...etc.)\n* 3\\. No recurrent pregnancy loss and stable condition in the first trimester of pregnancy.\n* 4\\. Using smart phone.\n* 5\\. Being willing to participate in this study.\n\nExclusion Criteria:\n\n\\- 1. No diagnosis of diabetes mellitus before pregnancy.","20 Years",{"count":251,"type":21},600,[24],"Background: The gestational diabetes mellitus and perinatal depression are both global public health issues with high prevalence. Non-perinatal diabetes mellitus and depression are confirmed to have reciprocal influence, which is bidirectional relationship. However, there are still no any confirmations of relationship in the perinatal period. The reason could be that these kinds of studies mostly had been done for postpartum depression, they had rarely been discussed with a clearly sequential influence between gestational diabetes mellitus and perinatal depression. Additionally, there have not been so many Asian countries which been done this kind of studies, therefore, this study will focus on the relationship of gestational diabetes mellitus and perinatal depression.\n\nPurpose: This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression. In the other words, the prenatal depression influences on gestational diabetes mellitus, and vice versa. Those changeable factors, such as social support, health behavior, prenatal body index, weight gain during pregnancy, perinatal complications…etc, will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depression.Afterwards, a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior, then depression and other obstetrics and gynecological results will be tested for effects.",[255,226,29],"Gestational Diabetes Mellitus",[257,255,29,226,258],"Antepartum Depression","Health Interventions","2026-03-19",{"date":261,"type":40},"2026-03-23",{"date":263,"type":40},"2023-10-26",{"date":265,"type":21},"2026-12-31",{"name":99,"class":47},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":71},"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":275,"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.",[27,29],[117,90,280,281,282,283,284],"Postpartum","Perinatal Mood and Anxiety Disorders","Cognitive Behavioral Therapy","Mobile App","mobile Health (mHealth)","2026-02-24",{"date":287,"type":40},"2026-02-27",{"date":289,"type":40},"2023-09-19",{"date":291,"type":21},"2027-02",{"name":293,"class":47},"Weill Medical College of Cornell University",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":4},"100616383","center-m-randomized-trial-100616383","NCT07304895","Center M Randomized Trial","Inclusion Criteria:\n\n* Currently pregnant at ≥ 12 weeks of gestation age (GA)\n* ≤ 34 weeks GA at time of Center M intervention initiation\n* Receiving prenatal care through the Center for Women's Health at Oregon Health \\& Science University\n* Able to fluently understand, speak and read English\n* Available, able and willing to attend online group sessions\n* Willing and able to receive home practice materials on an accessible smartphone, tablet or computer\n* Residing in Oregon or Washington\n* Willingness to participate in either randomization arm\n\nExclusion Criteria:\n\n* Current or past enrollment in a formal mindfulness-based intervention group\n* Score in the \"severe\" range on the Edinburgh Postnatal Depression Scale (EPDS) (≥ 20) or Patient History Questionnaire (PHQ-9) (≥ 20)",{"count":301,"type":21},160,[24],"This is a randomized controlled trial with an intervention of Center M compared to treatment as usual. Center M consists of weekly digital one-hour group sessions led by a trained therapist aligned with mindfulness based cognitive therapy. Changes in perinatal depression symptoms will be compared between groups.",[29],[306],"mindfulness based cognitive therapy","2025-12-11",{"date":309,"type":40},"2025-12-26",{"date":311,"type":21},"2025-12",{"date":313,"type":21},"2026-12",{"name":315,"class":47},"Oregon Health and Science University",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":324,"phases":4,"briefSummary":325,"conditions":326,"keywords":329,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":340,"locationsCount":71},"100533882","the-relationship-between-maternal-perinatal-depression-and-feeding-behavior-among-primiparas-100533882","NCT06231602","The Relationship Between Maternal Perinatal Depression and Feeding Behavior Among Primiparas","Inclusion Criteria:\n\n* Primipara\n* Adult women over 18 years old\n* Those with no recurrent pregnancy loss and stable signs of pregnancy\n* Those who agree to participate in this study\n\nExclusion Criteria:\n\n* No exclusion conditions",{"count":323,"type":21},500,"OBSERVATIONAL","The goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Participants will be asked to finish questionnaires four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum).",[29,327,328],"Breastfeeding","Complementary Feeding",[330,331,332,333],"prenatal depression","postpartum depression","breastfeeding","complementary feeding","2025-11-16",{"date":336,"type":40},"2025-11-19",{"date":338,"type":40},"2024-02-19",{"date":265,"type":21},{"name":99,"class":47},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":79,"sex":108,"minAge":4,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":71},"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":350,"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.",[29,27],[355,33,115],"Doulas","2025-10-21",{"date":358,"type":40},"2025-10-22",{"date":356,"type":40},{"date":361,"type":21},"2027-06",{"name":363,"class":47},"Beth Israel Deaconess Medical Center",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":382,"locationsCount":71},"100367807","implementation-of-prevention-and-intervention-of-maternal-perinatal-depression-to-strengthen-maternal-and-child-health-100367807","NCT04069091","Implementation of Prevention and Intervention of Maternal Perinatal Depression to Strengthen Maternal and Child Health","IMPRINT","Inclusion Criteria:\n\n* EPDS screen result of 10 or more\n* Agreed to be invited for the intervention during the screening phase\n\nExclusion Criteria:\n\n* Active suicidality\n* Presence of severe mental disorder\n* Concurrent use of psychotropic medication \u002F concurrently under psychosocial treatment for mental disorder",{"count":372,"type":21},1000,[24],"IMPRINT strengthens maternal and child health by screening, treating and preventing maternal perinatal depression, the most common complication of pregnancy and the child's first 1000 days. It is associated with poor pregnancy outcome and perinatal mortality and has adverse consequences on physical and mental development of the child. Yet, only 7-28% of women with perinatal depression worldwide receive appropriate evidence-based care. This is astounding given that the need of investing on mental health is widely recognized and low-intensity interventions not requiring costly mental health professionals have been shown to be effective.\n\nIMPRINT improves the effectiveness, reliability, safety, appropriateness, equity and efficiency of routine health care provided for the mother and the child during the child's first 1000 days of life. The investigators 1) have adapted into the gender-, country-, and cultural-context an existing evidence-based, low-intensity pregnancy intervention targeting maternal perinatal depression (online CBT-based therapy) (iloodottaa.fi); 2) test in cluster-randomised trial the short- and long-term efficacy of the intervention in women who report clinically relevant, subthreshold or more severe symptoms in an early pregnancy depression screen; 3) study biological, psychological and social determinants of depressive symptom severity, comorbidities and response to interventions. The study recruits women from 58 antenetal clinics in the cities of Helsinki, Vantaa, Keski-Uusimaa, Kuopio and Lohja and aims at recruiting 500 women to the intervention and 500 women to the control arms.\n\nBecause of low recruitment rate, the cluster-randomized clinical trial design was changed to a single-arm clinical trial. All pregnant mothers who meet the inclusion criteria are eligible to participate in the CBT-intervention. In parallel with the change in study design, recruitment expanded to cover all antenatal clinical in the well-being services counties: Helsinki, Vantaa and Kerava, Central Uusimaa, Western Uusimaa (Lohja), Eastern Finland, and Pirkanmaa. Amendment to HUS ethical committee, approval date: June 26 2024; Amendment to HUS research permit, approval date: August 8 2024; Approvals from the counties participating in the study, approval dates: by October 31 2024.",[29],"2025-09-24",{"date":378,"type":40},"2025-09-30",{"date":380,"type":40},"2020-01-01",{"date":97,"type":21},{"name":383,"class":47},"Katri Räikkönen",{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":398,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":409},"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.",{"count":391,"type":21},125,[24],"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.",[115,395,396,116,397,29],"Depression, Postpartum","Anxiety in Pregnancy","Anhedonia",[115,116,117],"2025-09-16",{"date":401,"type":40},"2025-09-19",{"date":403,"type":40},"2024-10-01",{"date":405,"type":21},"2026-12-30",{"name":407,"class":408},"BlueSkeye AI","INDUSTRY",2,{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":426,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":71},"100590513","accelerated-tms-for-perinatal-depression-100590513","NCT06968390","Accelerated TMS for Perinatal Depression","Perinatal Accelerated iTBS Neuromodulation Therapy","PAiNT","Inclusion Criteria:\n\n* Age 18-55\n* All individuals must be 14-34 weeks gestational age or within one year of delivery at the time of treatment. The odds of delivery nears 10% after 36 weeks, which would limit participants from being able to complete the study and interfere with the primary study aim to understand safety and tolerability. Additionally, after 36 weeks, the standard of care is weekly obstetric check-in visits, which would be challenging for patients to complete given the time demands of the study protocol.\n* Patients will not be scanned after 32 weeks gestational age due to the time needed to construct the individualized treatment target. Individuals seeking treatment beyond 32 weeks will be offered scalp-based target localization so as not to limit patient access to care.\n* English proficiency sufficient for informed consent, questionnaires\u002Ftasks, and treatment\n* Primary diagnosis of major depressive disorder per DSM-V criteria (MINI International Neuropsychiatric Interview\u002F Structured Clinical Interview for DSM-5): \\>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and moderate to severe level of treatment resistance (Maudsley Staging Method)\n* Stable antidepressant medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the treatment course. We request that this regimen remain stable until the 1 month post-treatment if clinically appropriate.\n* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial in addition to an obstetric provider responsible for obstetric care.\n* Agreement to lifestyle considerations: Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment\n\nExclusion Criteria:\n\n* Concurrent use of rapid acting antidepressant agent (ketamine\u002Fesketamine\u002FECT)\n* Receiving or planning to receive other TMS treatments during course of participation\n* Obstetric concerns: Preeclampsia and\u002For current frequent, painful contractions (more than one every 10 minutes)\n* History of: Neurosurgical intervention for depression, autism spectrum disorder, intellectual disability, severe cognitive impairment, significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion), untreated or insufficiently treated endocrine disorder, and\u002For treatment with investigational drug or intervention during the study period\n* ≥ 30% change in MADRS score between screening and baseline\n* Anyone presenting with: Mania or hypomania, psychosis, active suicidal ideation with plan and some intent to act or a suicide attempt (defined by C-SSRS) within the past 3 months, neurological lesion, contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \\> 4 hours per night with hypnotic, etc.), and\u002For current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal\n* Existing tinnitus (ringing in the ears) that causes functional impairment\n* History of retinal detachment or other retinal pathology\n* Severe borderline personality disorder\n* Any other condition deemed by the PI to interfere with the study or increase risk to the participant","55 Years",{"count":420,"type":21},24,[24],"We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a focal, non-invasive form of brain stimulation that is cleared by the Food and Drug Administration for depression. Typically, traditional TMS involves daily treatments for 6-8 weeks. In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days.",[29,424,425],"Post Partum Depression","Major Depressive Disorder",[427,428,29,117,280,226,425,429],"TMS","Accelerated TMS","Pregnant","2025-09-03",{"date":432,"type":40},"2025-09-09",{"date":434,"type":40},"2025-08-05",{"date":436,"type":21},"2027-01-01",{"name":438,"class":47},"Brigham and Women's Hospital",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":79,"sex":108,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":324,"phases":4,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":71},"100561753","validation-of-the-french-version-of-the-perinatal-assessment-of-paternal-affectivity-papa-100561753","NCT06594263","Validation of the French Version of the Perinatal Assessment of Paternal Affectivity (PAPA)","Cross-cultural Adaptation and Validation of the French Version of the PAPA (Perinatal Assessment of Paternal Affectivity) Self-questionnaire Assessing the Psychological Experience of Fathers Pre- and Post-natal","French-Papa","Inclusion Criteria:\n\n* Woman and its male partner aged 18 years old and older\n* Couple understanding, speaking and reading French\n* Couple giving their informed consent to participate voluntarily\n\nExclusion Criteria:\n\n* Woman without male partner\n* Woman admitted to intensive care after giving birth\n* Couple whose newborn died peripartum\n* Couple who have had a medical abortion or fetal death in utero for the current pregnancy\n* Woman and\u002For male partner refusing to participate in the study\n* Woman and\u002For male partner not speaking French\n* Woman and\u002For male partner in the incapacity to answer the questionnaires\n* Woman and\u002For male partner under guardianship or conservatorship, deprived of liberty, or in the custody of correctional authorities",{"count":448,"type":21},340,"The transition to parenthood is a critical period for both the woman and her partner, and this can affect the mental health of the parents. Like mothers, fathers are at risk of stress, anxiety, depression and post-traumatic stress disorder during the perinatal period.\n\nExisting screening or diagnostic tools have been developed on the basis of traditional depressive symptoms expressed by women. However, the manifestations of perinatal mental disorders appear to be different in men. It is therefore essential to develop tools that are sensitive and specific to both gender and the perinatal period in order to increase the sensitivity and specificity of screening for fathers.\n\nIn France, to the best of the knowledge of the investigators, there is no validated tool in French to assess paternal psychological disorders, either prenatally or postnatally. Baldoni et al. had validated a brief self-report questionnaire, the \" Perinatal Assessment of Paternal Affectivity \" (PAPA), to screen for perinatal signs and symptoms of paternal affective disorder, using a gender-sensitive approach.\n\nThe aim of this study is to cross-cultural adapt the PAPA in French and to evaluate its psychometric properties.\n\nThis validation of the French-PAPA would provide a simple tool, easy to use in everyday practice, to detect any signs or symptoms of paternal psychopathological distress in the pre- and postnatal period.",[29,451,452],"Affective Disorder","Fathers",[452,117,454,455,115,456,457],"Cross-cultural adaptation","Validation","Affective disorders","Screening","2025-08-11",{"date":460,"type":40},"2025-08-14",{"date":462,"type":40},"2024-10-19",{"date":464,"type":21},"2026-11-18",{"name":466,"class":47},"University Hospital, Clermont-Ferrand",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":486,"leadSponsor":487,"locationsCount":71},"100550362","a-chinese-version-of-the-thinking-health-program-for-east-asian-pregnant-immigrant-people-in-canada-100550362","NCT06446089","A Chinese Version of the Thinking Health Program for East Asian Pregnant Immigrant People in Canada","The Feasibility of a Culturally Tailored Mobile App-based Thinking Healthy Program for Mental Health Support of East Asian Pregnant Immigrants in Canada","Inclusion Criteria:\n\n* pregnant women at ≥ 22 weeks of gestation; AND\n* ≥ 18 years old; AND\n* are first or second-generation Chinese immigrants residing in Canada (who identify as someone with East Asian cultural and ethnic background born outside of Canada or have at least one parent born outside of Canada); AND\n* understand both spoken and written Mandarin language; AND\n* have access to internet and a smartphone with Android operating system or willing to download an Android emulator to operate the App; AND\n* are willing to download and use the study mobile App with brief Chinese version of THP for \"talking therapy\" with accompanying activities.\n\nExclusion Criteria:\n\n* Women currently being treated for mental conditions, including depression",{"count":475,"type":21},50,[24],"The goal of this study is to determine the feasibility of using a psychosocial intervention culturally adapted in China to support perinatal mental well-being of Chinese immigrant pregnant women in Canada. The intervention is adapted from the Thinking Healthy Program (THP), available through a mobile application, and will be offered to Chinese immigrant pregnant women (22 weeks' gestation or greater) residing in Canada, who are over the age of 18, and speak Mandarin. The main questions this study aims to answer are:\n\n* Will the Chinese version of the THP be acceptable to Chinese immigrant pregnant women residing in Canada and will they use the program which is delivered through a mobile App?\n* How well does the process of recruiting, keeping participants in the study and helping them complete the activities work, so it can be used for a future larger study?\n\nWomen interested in the study and who meet the study criteria will complete a questionnaire at the start of the study, then use the THP for three weeks, complete questionnaires 3-4 weeks after completing the intervention and 6-8 weeks after having their baby(ies). Some may be asked to participate in an individual interview.",[29],[480,481],"immigrant women","East-Asian immigrants","2025-07-23",{"date":484,"type":40},"2025-07-28",{"date":403,"type":40},{"date":311,"type":21},{"name":488,"class":47},"Queen's University",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":497,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":71},"100595077","clinical-and-cost-effectiveness-of-an-online-self-help-intervention-and-a-face-to-face-intervention-versus-usual-care-in-mothers-at-moderate-risk-for-perinatal-depression-100595077","NCT07027761","Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression","Maternal Mental Health Intervention (MaMHI) Study: A Combined Non-inferiority and Superiority Randomized Controlled Trial Comparing the Clinical and Cost-effectiveness of an Online Self-help Intervention and a Brief Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression Identified by a Concentration-of-risk Prediction Approach.","MaMHI","Inclusion Criteria:\n\nParticipants will be drawn from the broader PRIL (Perinatal mental health Profiling and Intervention in Leuven) study, who consented to being contacted for the intervention trial and who meet criteria for moderate risk for perinatal depression based on an analytical epidemiological approach aligned with precision medicine principles, specifically a concentration-of-risk prediction modeling approach. Based on a comprehensive assessment of biological, psychological and social risk and protective factors, concentration-of-risk models will be developed and validated to stratify respondents in terms of risk for future perinatal depression, namely (1) not, (2) mildly, (3) moderately and (4) highly at risk of developing perinatal depression. Mothers falling into the moderate risk profile are eligible to participate\n\nExclusion Criteria:\n\n* Receiving concurrent psychological guidance in perinatal mental health problems;\n* Not consenting to (a) audiorecording of the first two face-to-face sessions and\u002For (b) paying the appropriate fee, in case of randomization to the face-to-face intervention arm.","16 Years",{"count":499,"type":21},210,[24],"The perinatal period (pregnancy and the first postnatal year) (O'Hara \\& Wisner, 2014) involves important changes and considerable challenges for parents (Milgrom \\& Gemmill, 2015). As a result, perinatal mental health (PMH) disorders are highly prevalent. It is estimated that 1 in 5 women meet criteria for mental health disorders during the perinatal period (Van Damme et al., 2018). These psychological problems not only significantly impact (expectant) mother's own wellbeing, but also that of their children, partners, and their support networks. Additionally, PMH problems are associated with significant financial burden. For instance, In the UK perinatal depression and anxiety are estimated to cost approximately £8.1 billion per annual birth cohort (Bauer, 2015). Prevention of these problems is therefore essential. Unfortunately, in up to 75% of women symptoms of depressive or anxiety disorders are not detected timely, and only 10% of these women receive appropriate help (Kingston et al., 2015).\n\nThis study proposes a novel approach to intervention by investigating the effectiveness of psychosocial treatments for (expectant) mothers identified to be at moderate risk of developing perinatal depression based on a novel statistical risk modeling approach. Specifically, we will investigate the clinical and cost-effectiveness of (a) an online self-help program and (b) a brief face-to-face (FTF) intervention for expectant mothers with a moderate risk of developing perinatal depression, compared to (c) standard care (treatment as usual). We expect both active treatments to be superior compared to standard care and similar in effectiveness to each other. In addition, we expect both online self-help and the brief FTF intervention to be more cost-effective compared to usual care. Moreover, we will also investigate the effects of the three treatments on a range of other important outcomes, participants' satisfaction with the treatments, the credibility of the treatments and expected effects as rated by patients. Finally, in a small qualitative study, we will investigate the subjective experiences of participants in the brief FTF intervention specifically.",[29],[504],"Perinatal depression; maternal mental health; face-to-face intervention; online self-help; early intervention, brief psychotherapy; psychodynamic therapy.","2025-06-10",{"date":507,"type":40},"2025-06-18",{"date":509,"type":21},"2025-06-15",{"date":511,"type":21},"2028-10-31",{"name":513,"class":47},"Universitaire Ziekenhuizen KU Leuven",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":108,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":532,"leadSponsor":533,"locationsCount":71},"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":522,"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.",[29,27],[115,116,117,527,118,119],"Well-being","2025-05-02",{"date":530,"type":40},"2025-05-07",{"date":528,"type":40},{"date":311,"type":21},{"name":127,"class":47},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":71},"100519890","maternal-mental-health-access---mama-100519890","NCT06049433","Maternal Mental Health Access - MaMa","Prevention of Perinatal Depression Among At-risk Individuals Through Integration of a Multimedia, Web-based Intervention Within the Healthcare System","MaMa","Inclusion Criteria:\n\n* 18+ years of age, who at the time of screening\n* Have a viable pregnancy or are postpartum (up to 1 year)\n* Identified as at-risk for PD (any one of the following:\n* EPDS score equal to or greater than 9 or less than 21\n* History of depression\u002Fanxiety\n* 2 or more significant life events)\n* English- or Spanish-speaking\n* Currently attending a UHealth clinic or rural public health partner clinic.\n\nExclusion Criteria:\n\n* Have a substance use disorder\n* Current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including EPDS \\> 20)\n* Severe anxiety, suicidality, or currently taking any medications for a mental health condition.",{"count":543,"type":21},120,[24],"This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory.\n\nUsing the Implementation Research Logic Model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand MBCT PD prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. Successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated Digital Mental Health Technology and to estimate the cost\u002Fbenefit ratio",[226,29],"2024-12-04",{"date":549,"type":40},"2024-12-06",{"date":551,"type":40},"2023-04-04",{"date":553,"type":21},"2025-12-30",{"name":555,"class":47},"University of Utah",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":220,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":569,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":71},"100567764","preventing-perinatal-depression-with-an-app-based-cbt-program-100567764","NCT06672432","Preventing Perinatal Depression with an App-Based CBT Program","Preventing Perinatal Depression Using an App-based Cognitive Behavioral Therapy Program","Inclusion Criteria:\n\n* aged 18-45 years\n* at 20-24 weeks of gestation\n* at risk of depression but not experiencing severe depressive symptoms at recruitment, as indicated by an Edinburgh Postnatal Depression Scale (EPDS) score of between 5 and 12\n* own a smartphone\n* are able to independently engage with the program\n\nExclusion Criteria:\n\n* have serious medical conditions or pregnancy complications that may affect their psychological condition, as determined by their medical doctor\n* have a prior diagnosis of any mental disorders\n* are currently or were recently (within the past six months) receiving any kinds of psychological services or treatments\n* have a history of self-harm or suicide\n* have any suicidal thoughts in the past 12 months\n* experienced fetal deaths in the past 18 months",{"count":564,"type":21},290,[24],"The goal of this clinical trial is to learn if CareMom, a mobile app-based cognitive behavioral therapy program works to prevent perinatal depression among Chinese mothers. The main questions the trial aims to answer are:\n\n1. Does CareMom lower depression scores after an 8-week intervention?\n2. Does CareMom lower depression scores at 6 weeks after childbirth?\n3. How satisfied are participants with CareMom?\n4. What unfavorable events, if any, are associated with the use of CareMom?\n\nResearchers will compare CareMom to a matched attention control (a mobile app-based program that offers participants a similar level of interaction and daily activities) to see if CareMom works to prevent perinatal depression.\n\nParticipants will:\n\n1. Engage in the CareMom program or a relaxation training program every day for 8 weeks\n2. Complete a series of online questionnaire tests before and after the 8-week intervention.\n3. Report any discomfort experienced throughout the study period.",[29,568],"Disease Prevention",[229,570,571],"cognitive behavioral therapy","iCBT","2024-10-31",{"date":574,"type":40},"2024-11-04",{"date":576,"type":21},"2024-11",{"date":578,"type":21},"2025-11",{"name":580,"class":47},"Jintang County Maternal and Child Health Hospital",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":220,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":71},"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).",{"count":589,"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.",[593,27,29],"Sleep Disturbance","2024-09-28",{"date":403,"type":40},{"date":597,"type":40},"2023-08-10",{"date":599,"type":21},"2025-09",{"name":601,"class":47},"St. Joseph's Healthcare Hamilton",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":614,"conditions":615,"keywords":617,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":71},"100521796","phase-2-perinatal-depression--anxiety-pda-and-maternal-gut-microbiome-100521796","NCT06074250","Perinatal Depression & Anxiety (PDA) and Maternal Gut Microbiome","Targeting Maternal Gut to Improve Mental Health Outcomes-- A Feasibility Pilot Clinical Trial","Inclusion Criteria\n\n* Women 18-43 years old\n* 12-35 weeks of gestation\n* Non-smoker\u002Falcohol\u002Frecreational drug user\n* Financially stable\n* Clinical diagnosis of lifetime depression\u002Fanxiety or PDA but currently well\n* English speaking\n\nExclusion Criteria:\n\n* Body Mass Index (BMI)≥30\n* Low income (unable to afford basic daily needs (i.e., shelter, food, etc.)\n* Diagnosis with other major mental health disorders (Bipolar, Psychosis, Addiction, Schizophrenia);\n* Diagnosis with other severe medical conditions (i.e. epilepsy, neurological disorders, etc.)\n* Allergies to fish oils\u002Fingredients in supplements\n* Conditions that require repeated\u002Fchronic antibiotic usage\n* Having a child with significant mental\u002Fphysical disability\n* Single mothers without any kind of family support,\n* Cigarette, alcohol and recreational drug users\n* Women unwilling to switch to study product(s)\n* Multiparous women with young children (i.e. one or more children less than 4 years of age at the time of delivery)\n* Non-English Readers\u002FSpeakers","43 Years",{"count":81,"type":21},[612,613],"PHASE2","PHASE3","Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary\u002Fsupplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children.\n\nThe investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided.\n\nThe findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and\u002For supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.",[29,616],"PerinatalAnxiety",[618,619,620,621,622,623,624,625],"Gut Microbiome","Gut-Brain Axis","Diet","Omega 3 Fatty acids","Probiotics","Fish Oil","Mental Health disorders","Perinatal Depression and anxiety","2024-08-22",{"date":628,"type":40},"2024-08-27",{"date":630,"type":40},"2024-08-15",{"date":632,"type":21},"2028-03",{"name":634,"class":47},"The Canadian College of Naturopathic Medicine",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":324,"phases":4,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":71},"100552503","maternal-well-being-in-the-perinatal-period-100552503","NCT06473935","Maternal Well-being in the Perinatal Period","Maternal Well-being in the Perinatal Period: a Prospective Observational Study","Inclusion Criteria:\n\n* Age 18 years or older\n* Adequate understanding of the Italian language\n* Willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement\n* Women experiencing their first pregnancy\n* Women in the last trimester of gestation (28th-35th week of gestation) who will be followed for 18 months after childbirth\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Women who are not able to understand the Italian language\n* Absence of the willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement\n* Women who are not experiencing their first pregnancy\n* Women who are not in the last trimester of gestation (28th-35th week of gestation)",{"count":643,"type":21},134,"The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.",[29,116,646,647],"Loneliness","Mother-Child Relations","2024-06-19",{"date":650,"type":40},"2024-06-25",{"date":652,"type":40},"2024-06-01",{"date":654,"type":21},"2025-12-31",{"name":656,"class":47},"IRCCS San Raffaele"]