[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postpartum-anxiety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postpartum-anxiety":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,50,92,105,132,162,187,214,244,270,301,329,353,380,409,439,472],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054124","feasibility-and-acceptability-of-a-novel-digital-intervention-to-prevent-paternal-postpartum-depression-100054124",false,"NCT07594743","Feasibility and Acceptability of a Novel Digital Intervention to Prevent Paternal Postpartum Depression","Pilot Randomized Trial of Together in Parenting, a Novel Digital Paternal Postpartum Depression Prevention Intervention","TIP RCT","Inclusion Criteria:\n\n1. English-speaking (for now, TIP is only available in English)\n2. age \\>18 years old,\n3. smartphone ownership or access to home internet,\n4. partner or patient received or receiving prenatal care from a resident or nurse-practitioner\u002Fmidwifery clinic at the Obstetrics and Gynecologic Care Center (OGCC) at Women \\& Infants Hospital of Rhode Island (WIHRI) or receiving an ultrasound at the WIHRI's Prenatal Diagnosis Center ,\n5. planned delivery or status post delivery at WIHRI.\n\nExclusion Criteria:\n\n1. Any self-reported active diagnosis or history of mental health conditions including depression, anxiety, or other psychiatric condition, as per patient report;\n2. Endorsing active suicidality on intake survey or screening positive on the MDS (≥13)16 or GAD-7 (≥8) at time of enrollment;\n3. prisoners;\n4. infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment;\n5. inability to consent. If new results on the MDS or GAD-7 indicate a positive screening or the father's infant(s) is diagnosed with a genetic abnormality, significant anatomic malformation, or NICU admission after the enrollment and randomization period, the father will still be eligible to continue participation in the study. This information will be tracked in the REDCap database.",true,"ALL","18 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","Postpartum depression (PPD) occurs almost as often among men as it does among women. However, while there have been multiple programs designed to prevent maternal PPD, few, if any, interventions exist that have been created specifically to prevent paternal PPD. After engaging in evidence-based qualitative research with soon-to-be or new fathers, a novel interpersonal-therapy based digital program was created to prevent paternal PPD called Together in Parenting (TIP), which comprises multiple podcasts and digital educational handouts. The proposed pilot study will examine the feasibility and acceptability of using TIP as a paternal PPD intervention, will determine the optimal timing of administering TIP to future\u002Fnew fathers, and will generate preliminary estimates of effect of the intervention to support a future efficacy study.",[28,29],"Paternal Postpartum Depression","Postpartum Anxiety",[31,32,33,34,35,36],"paternal postpartum depression","paternal postpartum anxiety","maternal postpartum depression","postpartum perceived stress","maternal postpartum anxiety","dyadic adjustment","RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2026-07-07",{"date":45,"type":22},"2027-12-01",{"name":47,"class":48},"Women and Infants Hospital of Rhode Island","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":49},"100527171","whole-body-hyperthermia-for-mood-and-anxiety-disorders-100527171","NCT06144294","Whole-Body Hyperthermia for Mood and Anxiety Disorders","Inclusion Criteria\n\n* Group 2\n\n  * Arm 1: Healthy women or transgender men 18-50 years of age, ≤ 6 months postpartum\n  * Arm 2: Women and transgender men 18-50 years of age, ≤ 6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI.\n  * Arm 3: Healthy adults of both sexes 18-50 years of age.\n  * Arm 4: Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the Mini International Neuropsychiatric Interview (MINI)\n* Group 2: Sub-study\n\n  * Subjects enrolled in Group 2 are eligible for an optional additional sub-study (Group 2: Sub-study); inclusion criteria are the same as for Group 2.\n\nExclusion criteria for all:\n\n* For logistics, we will exclude individuals with BMI \\>30 and waist size \\> 35, who may not fit comfortably in the sauna dome for all cohorts described above.\n* For contraindications to hyperthermia, we will exclude from all cohorts listed above, individuals with severe cardiovascular disease, including congestive heart failure, coronary artery disease, uncontrolled hypertension, and hypotension; pregnancy; active substance use disorders; recent major injuries or surgeries (\\\u003C1 week prior); impaired sweating (those with multiple sclerosis, diabetes mellitus with neuropathy, central nervous system disease, heat insensitivity); a history or family history of malignant hyperthermia, fever or active signs of infection; taking medications that may have interactions with hyperthermia (for example, barbiturates, diuretics, and beta blockers) and the use of an antipyretic or anihistamine medication in the 12 hours prior to the WBH intervention. Individuals with above mentioned conditions will be excluded since either WBH might deteriorate their conditions or it is unknown how their condition will be affected by WBH.\n* For contraindications to immune analyses, we will exclude individuals with conditions that might affect immune analyses, including individuals with known active autoimmune or endocrine disease and individuals with active infection at baseline.\n\nAdditional exclusion criteria by cohort or applicable study group:\n\n* Group 2\n\n  * Arm 1: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.\n  * Arm 2: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.\n  * Arm 3: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.\n  * Arm 4: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.\n* Group 2 and Group 2: Sub-study - All participants\n\n  * For contraindications to use of the e-Celsius capsule that will be used to measure core temperature, we will exclude individuals with pacemakers or any other electric medical implant, individuals with a current intestinal disorder that could lead to obstruction of the digestive tract including gastroparesis, individuals with history of diverticula, individuals with history of past surgical procedures in the gastrointestinal tract, individuals with a swallowing disorder and individuals with Crohn's disease.\n* Study Group 3 - All participants\n\n  * For contraindications to MRI, individuals with metal in the body will be excluded from participating in the MRI portion of the research since magnetic fields in MRI scanners can cause dangerous interactions in patients with metallic foreign bodies: projectile effect, twisting, burning, artifacts, and device malfunction (interference with a pacemaker).","50 Years",{"count":58,"type":22},240,[25],"This study aims to examine the scientific mechanisms of whole-body hyperthermia (WBH), a novel, rapidly acting, single session antidepressant and anxiolytic therapy. It also aims to determine its feasibility and acceptability in women with postpartum depression (PPD). The study will enroll four cohorts of participants: healthy postpartum controls; postpartum women with PPD; healthy adult controls; and adults with major depressive disorder or anxiety disorders in a longitudinal protocol.",[62,63,64,29],"Postpartum Depression","Mood Disorders","Anxiety Disorders",[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"postpartum depression","mood disorders","anxiety disorders","postpartum anxiety","whole-body hyperthermia","antidepressant therapy","anxiolytic therapy","postpartum feasibility and acceptability","psychoneuroimmunology","Broad-band neural suppression","EEG","Likert scale","inflammatory activity","pro-inflammatory cytokines","precision functional brain maps","fMRI","NOT_YET_RECRUITING","2026-06-18",{"date":85,"type":41},"2026-06-23",{"date":87,"type":22},"2028-06",{"date":89,"type":22},"2032-12",{"name":91,"class":48},"Weill Medical College of Cornell University",{"id":93,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":26,"conditions":96,"keywords":97,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":4},"100638818",{"count":21,"type":22},[25],[28,29],[31,32,33,34,35,36],"2026-05-12",{"date":100,"type":41},"2026-05-19",{"date":102,"type":22},"2026-06-01",{"date":45,"type":22},{"name":47,"class":48},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":112,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":49},"100537425","the-mom-and-infant-outcomes-momi-study-100537425","NCT06277661","The Mom and Infant Outcomes (MOMI) Study","The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems","Inclusion Criteria:\n\nTo be eligible for the MOMI PODS RCT, individuals will be required to be pregnant, with a current diagnosis or history of one or more of the following reflected in the medical record or by self-report - chronic hypertension (with or without super-imposed preeclampsia); gestational hypertension; preeclampsia; eclampsia; hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome; type 1 diabetes mellitus; type 2 diabetes mellitus; gestational diabetes mellitus (GDM); a depressive disorder (e.g., major depressive disorder, persistent depressive disorder) or anxiety disorder (e.g., generalized anxiety disorder, panic disorder).43-48 Inclusion criteria will also include a singleton pregnancy and medical record documentation or self-report of private or government-sponsored health insurance at the time of enrollment.\n\nExclusion Criteria:\n\nExclusion criteria will include the presence of a pre-existing, community driven MOMI PODS referral and enrollment into the program, maternal history of a seizure disorder, medical record documentation or self-report of a major complication of the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to anencephaly, myelomeningocele, esophageal atresia, gastroschisis, hypoplastic left heart syndrome, transposition of the great arteries, or tetralogy of Fallot. Exclusion criteria will also include the presence of a major genetic disorder among the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to trisomy 13, or trisomy 18 (trisomy 21 is not an exclusion criteria).","FEMALE",{"count":114,"type":22},384,[25],"The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192\u002Fgroup) following pregnancy affected by a cardiometabolic and\u002For mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.",[62,29,118],"Cardiometabolic Syndrome",[120,121,122,123],"Postpartum","Mental Health","Cardiometabolic Health","Maternal-Infant Health",{"date":125,"type":41},"2026-05-14",{"date":127,"type":41},"2024-06-27",{"date":129,"type":22},"2028-03-01",{"name":131,"class":48},"Ohio State University",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":112,"minAge":19,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100640076","mhealth-intervention-to-prevent-postpartum-depression-and-anxiety-in-chilean-women-wwwt-100640076","NCT07587177","mHealth Intervention to Prevent Postpartum Depression and Anxiety in Chilean Women (WWWT)","WHAT WERE WE THINKING\" (WWWT) PROGRAM: A DIGITAL INTERVENTION TO PREVENT POSTPARTUM DEPRESSION AND ANXIETY IN CHILEAN WOMEN","Inclusion Criteria:\n\n* First-time mothers (primiparous women)\n* Aged 18 years or older\n* Having a healthy, full-term infant younger than 2 months of age\n* Receiving prenatal or postnatal care at participating primary health centers in Chile\n* Having access to a mobile phone capable of receiving calls and text messages\n* Able to understand and communicate in Spanish\n\nExclusion Criteria:\n\n* Severe symptoms of depression or anxiety at baseline requiring immediate specialized mental health treatment\n* Severe psychosocial problems (e.g., substance abuse, domestic violence, significant cognitive impairment)\n* Infant born preterm or with severe medical conditions (e.g., genetic disorders or serious neonatal complications)\n* Inability to provide informed consent or participate in study procedures due to language or cognitive barriers",{"count":140,"type":22},220,[25],"The goal of this clinical trial is to evaluate the effectiveness of a digital psychoeducational intervention, \"What Were We Thinking\" (WWWT), to prevent the development of postpartum depression and anxiety symptoms in first-time mothers in Chile. The study includes adult women with a healthy, full-term infant younger than two months who are receiving care in primary health centers.\n\nThe main questions it aims to answer are:\n\n* Does participation in the WWWT intervention reduce depressive and anxiety symptoms at 3 months after the end of the intervention compared to usual care?\n* Does participation in the intervention improve maternal self-efficacy, perceived social support, and coparenting relationship quality compared to usual care? Researchers will compare an experimental group receiving the full WWWT intervention with a control group receiving usual care to determine the effectiveness of the intervention.\n\nParticipants will:\n\n* Complete self-report questionnaires assessing depressive symptoms, anxiety symptoms, maternal self-efficacy, perceived social support, and coparenting at baseline and at 3-month follow-up\n* Be randomly assigned to either the intervention group or the control group\n* Receive the WWWT intervention between 4 and 10 weeks postpartum (intervention group), including:\n\n  * Fourteen psychoeducational video modules (3-5 minutes each) delivered via text messaging over 4-5 weeks\n  * Individual contact with a trained facilitator through text messaging\n  * One virtual group session with other mothers and a facilitator\n* Continue receiving usual care in primary health services (control group) and receive a shortened version of the intervention after the follow-up assessment",[144,29],"Postpartum Depression (PPD)",[146,147,148,149,150,151,152,153],"Postpartum depression prevention","Postpartum anxiety prevention","Perinatal mental health","First-time mothers","mHealth intervention","Randomized controlled trial","Chile","What Were We Thinking (WWWT)","2026-05-08",{"date":125,"type":41},{"date":157,"type":22},"2026-05-01",{"date":159,"type":22},"2026-08-31",{"name":161,"class":48},"Universidad del Desarrollo",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":4},"100633539","hypno-breastfeeding-education-and-postpartum-outcomes-100633539","NCT07528001","Hypno-Breastfeeding Education and Postpartum Outcomes","The Effect of Hypno-Breastfeeding-Based Education on Postpartum Anxiety, Self-Compassion, Breastfeeding Motivation, and Breastfeeding Self-Efficacy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Primiparous mothers Aged between 18-40 years Within the first 72 hours postpartum Having a singleton birth Staying in the same room with the newborn (rooming-in) No medical condition preventing breastfeeding No chronic disease or pregnancy-related complications Did not receive breastfeeding education during pregnancy Able to understand and speak Turkish Willing to participate and provide informed consent\n\nExclusion Criteria:\n\n* Use of medications that interfere with breastfeeding Having a newborn admitted to the neonatal intensive care unit Diagnosed psychiatric disorder or use of psychiatric medication Participation in less than 80% of the intervention sessions Withdrawal from the study at any stage","40 Years",{"count":171,"type":22},102,[25],"This randomized controlled trial aims to examine the effects of hypno-breastfeeding-based education on postpartum anxiety, self-compassion, breastfeeding motivation, and breastfeeding self-efficacy among mothers in the early postpartum period. The postpartum period is a critical phase characterized by significant physical and psychological changes. Primiparous mothers, in particular, may experience anxiety, lack of confidence, and reduced motivation for breastfeeding, which may negatively affect breastfeeding success and mother-infant bonding.\n\nThe study will be conducted with 102 primiparous mothers aged 18-40 years within the first 72 hours postpartum. Participants will be randomly assigned to intervention and control groups. The intervention group will receive hypno-breastfeeding-based education, while the control group will receive routine care. The educational program includes principles of hypnosis, breastfeeding knowledge, anxiety management, self-efficacy enhancement, and self-awareness techniques, supported by guided relaxation, breathing exercises, and positive suggestion methods.\n\nData will be collected using validated scales, including the Postpartum-Specific Anxiety Scale, Self-Compassion Scale, Breastfeeding Motivation Scale, and Breastfeeding Self-Efficacy Scale. Appropriate statistical analyses will be performed.\n\nThe findings are expected to contribute to the development of psychoeducational nursing interventions, reduce postpartum anxiety, improve breastfeeding outcomes, and strengthen maternal adaptation.",[29],[176,29,177],"Hypno-breastfeeding","Breastfeeding Self-Efficacy","2026-04-07",{"date":180,"type":41},"2026-04-14",{"date":182,"type":22},"2026-04-15",{"date":184,"type":22},"2026-08-15",{"name":186,"class":48},"Saglik Bilimleri Universitesi",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":56,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":202,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100632957","short-term-mindfulness-intervention-for-anxiety-and-maternal-attachment-in-nicu-mothers-100632957","NCT07520435","Short-Term Mindfulness Intervention for Anxiety and Maternal Attachment in NICU Mothers","Effect of a Short-Term Mindfulness-Based Stress Reduction Program on Anxiety and Maternal Attachment in Mothers With Infants Admitted to the Neonatal Intensive Care Unit: A Randomized Controlled Trial","Inclusion Criteria:\n\nMothers aged 18 to 50 years Mothers whose newborns are admitted to the Neonatal Intensive Care Unit (NICU) Mothers of infants without congenital anomalies Mothers who have not previously participated in any mindfulness-based or psychological support program Mothers without cognitive impairment Mothers who are willing to participate voluntarily and comply with all study procedures Mothers who are able to communicate in Turkish\n\nExclusion Criteria:\n\nMothers who wish to withdraw from the study voluntarily Mothers whose infants are discharged from the NICU during the intervention period Mothers receiving MBSR or any other psychological therapy Mothers using psychopharmacological medication",{"count":195,"type":22},66,[25],"This randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal Intensive Care Unit (NICU). A total of 33 mothers will be recruited and assigned to intervention and control groups. The intervention group will receive a structured four-session mindfulness program, while the control group will receive standard care. Data will be collected using the Maternal Attachment Scale and the State-Trait Anxiety Inventory. The findings are expected to provide evidence on the effectiveness of mindfulness-based interventions in reducing anxiety and improving maternal-infant bonding during the postpartum period.",[29,199,200,201],"Postpartum Period","Maternal Behavior","Psychological Stress",[203,204,64,205],"Mindfulness","Mindfulness-Based Stress Reduction","Randomized Controlled Trial","2026-04-03",{"date":208,"type":41},"2026-04-09",{"date":210,"type":22},"2026-04-27",{"date":212,"type":22},"2026-07-01",{"name":186,"class":48},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":49},"100592641","essential-coaching-postpartum-evaluating-a-parent-focused-postpartum-text-message-program-in-nova-scotia-100592641","NCT06996067","Essential Coaching Postpartum: Evaluating a Parent-focused Postpartum Text Message Program in Nova Scotia","INCLUSION CRITERIA:\n\nEligible birthing parents will\n\n* early postpartum (\\\u003C7 days) with their first child\n* understand English\n* have a cell phone with text and data\n* be 18 years of age or old\n* live in Nova Scotia.\n\nEligible non-birthing parents will:\n\n* be early postpartum (\\\u003C7 days) with their first child\n* understand English\n* have a cell phone with text and data\n* be 18 years of age or old\n* live in Nova Scotia.\n\nEXCLUSION CRITERIA:\n\nParticipants (both birthing and non-birthing parents) will be excluded if:\n\n* newborn die or are expected to die prior to leaving the hospital\n* they have no access to mobile phone, either personal or shared\n* unwilling to receive SMS messages\n* decline or withdraw to participate\n* participated in a previous iteration of this project (e.g., either the development or evaluation).",{"count":221,"type":22},332,[25],"The transition to parenthood is often an exciting yet hard period for parents. In the first year after a new baby, many parents feel less confident, have more anxiety and depression, and feel more isolated and alone. During this time, many parents use their phones and the Internet to seek out information and support. Thus, the investigators are exploring the opportunity of using mHealth, or mobile health, to provide information directly to parents after the birth of their first baby. The investigators have developed a program for both birthing and non-birthing parents called the Essential Coaching Postpartum program. This program provides 332 parents with text messages sent for 6 weeks after birth to share information on newborn care and parent outcomes. This will be tailored based on whether they are the birthing parent (Essential Coaching for Every Mother) or non-birthing parent (Essential Coaching for Every Partner). The investigators will evaluate this program by comparing a group of parents who receive the messages to a group of parents do not receive any text messages. To determine the success of the Essential Coaching Postpartum program, the investigators will compare parents' confidence, anxiety, depression, and co-parenting between the two groups after six-weeks and six-months. The investigators believe that parents who get the text messages will have higher confidence and co-parenting outcomes and lower anxiety and depression. The investigator's goal with the Essential Coaching Postpartum program is to help make the first few weeks after a new baby less stressful by providing information and support directly to parents that they know they can trust.",[225,29,144,226,121,227],"Parenting Self-efficacy","Postpartum Stress","Co-parenting Practices",[229,230,231,232,233,234],"text messaging","non-birthing parent","birthing parents","mothers","fathers","digital health","2026-03-24",{"date":237,"type":41},"2026-03-27",{"date":239,"type":41},"2025-06-05",{"date":241,"type":22},"2027-06",{"name":243,"class":48},"IWK Health Centre",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":268,"locationsCount":4},"100616991","the-effect-of-art-based-mandala-coloring-activity-on-postpartum-anxiety-and-postpartum-depression-100616991","NCT07312812","The Effect of Art-Based Mandala Coloring Activity on Postpartum Anxiety and Postpartum Depression","Inclusion Criteria:\n\n* Able to speak and understand Turkish\n* Voluntarily agree to participate in the study and have signed the informed consent form\n* 18 years of age or older\n* Literate\n* Have not received any psychiatric diagnosis and are not currently receiving psychological or psychiatric support (therapy, counseling, or medication treatment)\n* Have not experienced any complications during delivery\n* Have a newborn with no malformation or anomaly\n* Have a newborn with no complications\n\nExclusion Criteria:\n\n* Have previously received psychological or psychiatric treatment or are receiving such treatment during the data collection period,\n* Have a serious neurological or psychiatric disorder that affects cognitive functioning,\n* Have serious health problems that prevent communication or participation in the study,\n* Have not provided informed consent,\n* Are unable to speak or understand Turkish,\n* Have experienced complications during delivery,\n* Have a newborn with a malformation or anomaly,\n* Have a newborn with any complications.","49 Years",{"count":252,"type":22},60,[25],"The postpartum period is a critical time for women's physical and psychological health, during which significant hormonal, emotional, and social changes occur. During this period, many women experience increased stress, anxiety, and emotional vulnerability while adapting to new parental responsibilities and caring for a newborn. When these challenges are not adequately managed, they may contribute to the development of postpartum anxiety and postpartum depression, which can negatively affect maternal well-being, mother-infant bonding, breastfeeding practices, and child development. Despite the importance of postpartum mental health, non-pharmacological and easily accessible supportive interventions remain limited.\n\nThis randomized controlled experimental study aims to evaluate the effect of a structured, art-based mandala coloring activity on postpartum anxiety and postpartum depression among postpartum women. The study will be conducted at Afyonkarahisar Health Sciences University Health Practice and Research Center, Obstetrics and Gynecology Clinic, and will include women who have recently given birth at this institution. Eligible participants will be randomly assigned to either an intervention group or a control group.\n\nWomen in the intervention group will receive individual training in mandala coloring before hospital discharge and will be provided with mandala coloring materials for home use. They will be encouraged to engage in the mandala coloring activity over an eight-week period and will be followed through regular telephone contacts. In addition to monitoring participation in the activity, individualized supportive counseling will be provided based on participants' needs. Women in the control group will receive routine postpartum care without any additional intervention.\n\nPostpartum anxiety and postpartum depression levels will be assessed at multiple time points during the study to examine changes over time. This study seeks to determine whether mandala coloring, as a low-cost and non-pharmacological art-based activity, may serve as a supportive approach to improve psychological well-being during the postpartum period. The findings may contribute to the development of accessible interventions aimed at supporting maternal mental health in the early postpartum period.",[62,29],[257,258,259,260,261],"woman","postpartum","depression","anxiety","mandala","2026-01-03",{"date":264,"type":41},"2026-01-07",{"date":266,"type":22},"2026-01-15",{"date":182,"type":22},{"name":269,"class":48},"Afyonkarahisar Health Sciences University",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":56,"enrollmentInfo":278,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":49},"100613873","narrative-nursing-for-cesarean-mothers-anxiety-and-breastfeeding-confidence-100613873","NCT07272252","Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence","Psychological Effects and Breastfeeding Self-Efficacy of a Structured Four-Step Narrative Nursing Intervention in Cesarean Mothers: A Randomized Controlled Mixed-Methods Study","NARRCARE","Inclusion Criteria:\n\n1. Women aged 18-50 years\n2. Scheduled for elective or non-emergency cesarean section at ≥37 weeks\n3. Able to communicate in Mandarin and provide written informed consent\n4. Expected hospital stay ≥24 h\n5. Singleton pregnancy with stable maternal and neonatal condition allowing routine mother-baby contact\n\nExclusion Criteria:\n\n1. Severe psychiatric disorders (schizophrenia, bipolar disorder, active suicidal ideation)\n2. Maternal or neonatal need for ICU\u002FNICU admission\n3. Emergency cesarean section preventing baseline assessment\n4. Communication or cognitive impairment precluding interview",{"count":279,"type":22},160,[25],"This study tests whether a nurse-led \"4-step narrative nursing\" program can reduce anxiety and improve breastfeeding confidence in mothers who are having a planned or non-emergency cesarean section.\n\nWhat is the problem? About 30-40% of Chinese cesarean mothers feel high anxiety after surgery, and 1 in 5 is at risk for postpartum depression. Low confidence in breastfeeding is also common.\n\nWhat will we do?\n\nWe will randomly assign 160 mothers (1:1) to either:\n\nUsual care - standard education and ward care, or\n\nUsual care plus narrative nursing - four short (10-20 min) conversations with a trained nurse:\n\nBefore surgery - help the mother talk about her fears. 24-48 h after surgery - encourage her to \"name\" pain or worries and separate them from herself.\n\nBefore discharge - guide her to find positive moments and build a \"strong-mom\" story.\n\nTwo weeks later by phone - strengthen the new story and review feeding success. What will we measure? Main result: anxiety score at 48 h (STAI scale). Other results: depression risk, breastfeeding confidence, pain, and feeding rates up to 3 months.\n\nPossible benefits:\n\nLower anxiety, better mood, higher breastfeeding rates. No drugs or extra procedures are involved, only talking.\n\nRisks:\n\nMinimal; some mothers may feel emotional during conversations, but nurses can pause or refer to counselling if needed.",[29,144,177,283],"Cesarean Section Wound",[285,286,287,69,288,289,290,291],"narrative nursing","storytelling intervention","cesarean section","breastfeeding confidence","mixed-methods","randomized controlled trial","China","2025-12-11",{"date":294,"type":41},"2025-12-18",{"date":296,"type":41},"2025-10-01",{"date":298,"type":22},"2026-03-01",{"name":300,"class":48},"Xi Huang",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":112,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":328},"100613147","psychological-and-physiological-impact-of-a-mindfulness-based-intervention-on-anxiety-disorders-during-the-postpartum-period-100613147","NCT07262801","Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period","Evaluating the Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period: A Proof of Concept Trial","Inclusion Criteria:\n\n* mothers\u002Fbirthing parents 18 years and older who are between 0-12 months postpartum\n* principal diagnosis of an anxiety disorder as per the Diagnostic Assessment Research Tool (DART; Schneider et al., 2022), with or without comorbid depression\n* no concurrent psychological treatment\n* 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; McQueen et al., 2016) and b) medications remain stable throughout the study\n* fluent in English, minimal grade 8 reading level.\n\nExclusion Criteria:\n\n* severe depression\u002Fsuicidality requiring acute intervention\n* women with psychotic or current alcohol or substance use disorders\n* suffering from severe claustrophobia\n* metallic objects in body (metal implants, pacemakers)\n* currently pregnant",{"count":309,"type":22},50,[25],"Postpartum anxiety (PPA) affects up to 20% of mothers in the first year after delivery, with mothers often reporting both psychological and physical symptoms. Present non-pharmacological interventions are effective at improving some psychological aspects of PPA such as anxiety, depressive mood, and distress. However, current interventions are not effective in improving emotion regulation (ER), something that many with PPA experience impairment in. Current interventions also seldom target the physical aspects of anxiety, such as bodily awareness - sensing and understanding internal signals in the body (e.g., sensing a fast heartbeat). There is a link between ER and bodily awareness, however psychological interventions that target both these aspects have not been investigated in the PPA population. As a result, a mind-body intervention targeting both ER and bodily awareness is needed to offer a more holistic treatment option.\n\nThe purpose of the proposed study is to test the effectiveness of a 4-week mindfulness intervention on anxiety symptoms, ER, and bodily awareness in those with PPA. We will use self-report questionnaires alongside brain imaging (functional magnetic resonance imaging; fMRI) to evaluate the effectiveness. Combining both subjective and objective measures will provide greater confidence in our findings, ensuring a more comprehensive understanding of the intervention's impact. Self-report questionnaires will be administered at enrolment, immediately post-intervention, and 4 weeks post-intervention. Brain imaging will be conducted at enrolment and immediately post-intervention. We believe this intervention will lead to improvements in anxiety symptoms, ER, and bodily awareness on the questionnaires and fMRI scans.\n\nIf effective, the proposed mindfulness intervention will target a broader range of psychological and physical symptoms, and reduce the negative impact of PPA on mothers and their infants in Canada and beyond.",[29,64],[69,68,232,314,315,316,317,81,318],"mindfulness","mindfulness-based intervention","emotion regulation","interoception","resting state functional connectivity","2025-12-01",{"date":321,"type":41},"2025-12-04",{"date":323,"type":22},"2025-12",{"date":325,"type":22},"2026-09",{"name":327,"class":48},"St. Joseph's Healthcare Hamilton",2,{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":112,"minAge":336,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":49},"100556154","postpartum-care-in-the-nicu-pelican-transitions-100556154","NCT06521398","Postpartum Care in the NICU (PeliCaN) Transitions","PeliCaN","Inclusion Criteria:\n\n* HUP postpartum patients who are at least 16 years old at the time their newborns' birth\n* Infant born at HUP\n* Preterm birth \\\u003C34 weeks\n* English language speaking\n\nExclusion Criteria:\n\n* Unable to read or sign informed consent\n* Parents of infants transferred into HUP NICU\n* If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks\n* HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth","16 Years",{"count":338,"type":22},20,[25],"This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.",[342,343,62,29],"Stress Disorders, Post-Traumatic","Premature Birth","2025-10-09",{"date":346,"type":41},"2025-10-14",{"date":348,"type":41},"2024-09-11",{"date":350,"type":22},"2027-08",{"name":352,"class":48},"University of Pennsylvania",{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":112,"minAge":19,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":49},"100503054","mother-infant-bonding-in-the-brain-a-mindfulness-based-intervention-100503054","NCT05830266","Mother-infant Bonding in the Brain: a Mindfulness-based Intervention","Mother-infant Bonding in the Brain: Promoting Maternal Mental Health and High-quality Mother-infant Interactions Via a Mindfulness-based Intervention","Inclusion Criteria:\n\n* Pregnant women (18+y).\n* First antenatal visit \\\u003C 12 weeks.\n* Score above cut off on the Edinburgh Postnatal Depression Scale (EPDS), the anxiety subscale of the Symptom Checklist (SCL-90) and\u002For the Parental Stress Questionnaire (PSQ) at 8-10 weeks postpartum.\n* Dutch-speaking or understanding Dutch.\n\nExclusion Criteria:\n\n* Gemelli pregnancy (or higher order pregnancy).\n* Known endocrine disorder before pregnancy (diabetes-I, Rheumatoid arthritis).\n* Severe psychiatric disease (schizophrenia, borderline or bipolar disorder).\n* HIV.\n* Drug or alcohol addiction problems.\n* Any other disease resulting in treatment with drugs that are potentially adverse for the fetus and need careful follow-up during pregnancy.\n* No access to the internet.",{"count":361,"type":22},64,[25],"The study investigates the effectiveness of the mindfulness-based intervention \"Mindful with your Baby\" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and\u002For parental stress. The intervention \"Mindful with your Baby\" is one of the very few interventions for maternal postnatal mental health issues that takes the bond between mother and infant into account. It is hypothesized that the \"Mindful with your Baby\" intervention will reduce levels of postpartum depression, anxiety and parental stress, and improve mother-infant behavioral interaction and increase neural synchrony between mother and infant brains.",[62,29,365],"Parental Stress",[367,368,369,203,370,371],"Postpartum depression","Postpartum anxiety","Parental stress","Mindful with your baby","Mother-infant interaction","2025-09-15",{"date":374,"type":41},"2025-09-19",{"date":376,"type":41},"2023-07-01",{"date":325,"type":22},{"name":379,"class":48},"Tilburg University",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":395,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":49},"100563006","powerly---science-based-digital-intervention-preventing-postpartum-depression-and-anxiety-100563006","NCT06610552","Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety","Real-life Implementation Randomized Clinical Trial Assessing Effectiveness of Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety","POWERLY app","Inclusion Criteria:\n\n* being between 24 and 32 weeks pregnant,\n* owning an iPhone,\n* having sufficient fluency in German language\n\nExclusion Criteria:\n\n* high-risk pregnancies,\n* history of substance abuse and psychiatric disorders such as bipolar disorder, schizophrenia, or other psychotic disorders,\n* current use of professional face-to-face psychotherapeutic support,\n* participation in other clinical trials or interventions at the same time",{"count":389,"type":22},140,[25],"The goal of this clinical trial is to determine if the Powerly app can help prevent postpartum depression and anxiety in healthy pregnant women.\n\nThe main questions it aims to answer are:\n\n* Does the Powerly app reduce postpartum depression and anxiety?\n* Does it improve emotion regulation and maternal bonding with a child?\n\nResearchers will compare two groups: one using the Powerly app and the other receiving care as usual (CAU) to see if the app leads to better mental health outcomes.\n\nParticipants will:\n\n* Use the Powerly app for four weeks (if in the intervention group).\n* Complete mental health assessments before the study, after four weeks, and six weeks postpartum.",[393,394,29],"Stress","Postpartum Depressive Disorder",[396,66,69,397,234,398,399],"pregnancy","stress","mobile health","ecological momentary intervention","2025-05-15",{"date":402,"type":41},"2025-05-20",{"date":404,"type":41},"2024-02-01",{"date":406,"type":22},"2026-10-30",{"name":408,"class":48},"Marta Marciniak",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":23,"phases":420,"briefSummary":421,"conditions":422,"keywords":427,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":437,"locationsCount":49},"100557963","improving-maternal-sleep-and-mental-health-100557963","NCT06544941","Improving Maternal Sleep and Mental Health","Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet","SHINE","Inclusion Criteria:\n\n* Pregnant women with a singleton gestation who have a military affiliation\n* Ages 18-45 years\n* Ability to communicate during the screening process\n* Access to a computer, smart phone or tablet with internet service\n* Willing to use bassinet they are randomized to\n* Willing to travel to a local Quest for blood draw\n\nExclusion Criteria:\n\n* Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.\n* Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.\n* Under the age of 18 years or \\> 45 years. The goal is to include women of childbearing age.\n* Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.\n* Tobacco use (current). Smoking is associated with poor sleep and inflammation.\n* Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and\u002For obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.\n* Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.","45 Years",{"count":419,"type":22},342,[25],"The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent\u002Fmitigate postpartum mood disorders by augmenting maternal sleep and\u002For enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual\u002Ftraditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nAim 1: Determine the effect of the SB on infant sleep and maternal sleep. \\[primary hypothesis or outcome measure 2\\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.\n\nMilitary-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.",[62,29,423,424,200,425,426],"Sleep Disturbance","Infant Behavior","Inflammation","Military Family",[428,258,429,430,259,260],"sleep","intervention","inflammation","2025-02-06",{"date":433,"type":41},"2025-02-10",{"date":435,"type":41},"2025-01-15",{"date":87,"type":22},{"name":438,"class":48},"University of Colorado, Colorado Springs",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":455,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":471},"100550108","mamaconecta-digital-tool-for-maternal-mental-health-100550108","NCT06442774","MamaConecta: Digital Tool for Maternal Mental Health","Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period","DDT","Inclusion Criteria:\n\n* Gestational age between 12-14 weeks of gestation.\n* The first obstetric ultrasound has been performed.\n* Women who know how to read and understand Spanish.\n* Women who have access to a mobile phone with an internet connection (data or wifi)\n* Women who have knowledge of technology tools via app.\n* Have signed the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Termination of pregnancy, or early miscarriage\n* Perinatal loss at any time during pregnancy.\n* Severe mental pathology or moderate unstable mental pathology.\n* Consumption of toxic substances.",{"count":448,"type":22},1200,[25],"The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are:\n\n* Does the app improve overall maternal well-being during the perinatal period?\n* Can the app increase the early detection rates of perinatal mental health disorders?\n* Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems?\n* How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants?\n\nResearchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes.\n\nParticipants will:\n\n* Use the mobile application from 12-14 weeks of gestation until 24 months postpartum.\n* Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data.\n* Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old.\n\nThis trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.",[452,453,62,29,454],"Pregnancy Related","Mental Health Issue","Well-Being, Psychological",[456,396,457,458,459,460,461,258,234],"mental health","mobile application","wellbeing","child neurodevelopment","antenatal depression screening","early detection",{"date":463,"type":41},"2025-01-17",{"date":465,"type":41},"2024-12-28",{"date":467,"type":22},"2027-12-31",{"name":469,"class":470},"A Thousand Colibris, S.L","INDUSTRY",3,{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":17,"sex":112,"minAge":19,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":486,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":49},"100568550","investigation-of-tvns-administration-on-postpartum-mental-health-100568550","NCT06682689","Investigation of TVNS Administration on Postpartum Mental Health","Integrative Investigation of Transcutaneous Vagus Nerve Stimulation: Impact on Postpartum Mental Health Through Wearable Technology, Hormonal Analysis and Modulatory Factors","Inclusion Criteria:\n\n* No malformation of fetal organs (no abnormalities detected during \"organ screening\").\n* Ability to provide written consent for themselves.\n* Sufficient German language skills to communicate and understand study procedures.\n\nExclusion Criteria:\n\n* Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems, cardiovascular health issues).\n* Cardiac arrhythmias or coronary heart disease.\n* Neurological disorders.\n* Current diagnosis or episode of a mood disorder.\n* Diagnosed schizophrenia spectrum and other psychotic disorders.\n* Severe substance use disorders.\n* Individual exclusion may also occur based on other health issues if the study clinician determines that participation in the study may pose a disadvantage for the participant or the child.",{"count":480,"type":22},120,[25],"The aim of the study is to explore whether transcutaneous vagus nerve stimulation (tVNS) may be effective in preventing mood swings and depressive symptoms in the postpartum phase, as well as serving as a supplementary intervention in cases where mood symptoms develop. The study will investigate the effects of tVNS intervention during the first 12 weeks postpartum. Pregnant women will be recruited for the study, and the intervention will begin shortly after giving birth. Participants will receive different instructions on how to use the tVNS device. Additional parameters such as physiological functions, chronic stress, hormones, environment, and personality traits will also be assessed.",[144,29,484,485],"Postpartum Sadness","Postpartum Blues",[487,488,120,489,490],"tVNS","Transcutaneous vagus nerve stimulation","PPD","Depression","2024-11-08",{"date":493,"type":41},"2024-11-12",{"date":495,"type":22},"2024-11",{"date":497,"type":22},"2026-12",{"name":499,"class":48},"University Hospital Tuebingen"]