[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postpartum-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postpartum-depression":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,51,94,126,150,178,204,235,257,285,308,334,366,387,412,443,469,492,511,539,571,595,617,643,668],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100558026","admission-to-kangaroo-mother-care-kmc-ward-and-maternal-postpartum-depression-100558026",false,"NCT06545760","Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression","Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial","KMC PPD","Inclusion Criteria:\n\n-AIM #1-2 and #5\n\nMothers to newborns who are:\n\n1\\) Birthweight between 1000-2000gm 2) Admitted to the Women and Neonates Hospital-University Teaching Hospital Neonatal Intensive Care Unit (WNH-UTH NICU) (\\>48hrs) 3) Stable preterm eligible for continuing kangaroo mother care (KMC) in the NICU or NICU discharge 4) 16+ years of age (Mother) 5) Residing within Lusaka Province with no intensions to relocate in the coming 18 months\n\n* AIM #3\n\n  1. Parents (mothers and fathers) whose newborn has been enrolled in the study\n  2. Trusted family member or friend of the mother whose newborns is enrolled into the study\n  3. 16+ years of age (mothers and fathers)\n  4. 18+ years of age (family members)\n* AIM # 4:\n\n  1. Fathers whose newborn has been enrolled into the study\n  2. 16+ years of age (father)\n\nExclusion Criteria:\n\n* AIM #1-2 and #5\n\n  1. Mothers who are on treatment for depression and\u002For anxiety\n  2. Mothers who did not consent\n  3. Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study\n* AIM #3\n\n  1\\) Family members of parents who do not consent to study participation\n* AIM # 4:\n\n  1. Fathers who are on treatment for depression and\u002For anxiety\n  2. Fathers who did not provide informed consent\n  3. Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study","ALL","1 Day","89 Years",{"count":22,"type":23},1908,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are:\n\n* Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting?\n* Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting?\n* What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting?\n* What is the prevalence of paternal depression in a low resource setting?\n* Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge?\n\nResearchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings.\n\nParticipants (infants) will:\n\n* At time of discharge from the NICU, when clinically stable, spend either \\\u003C 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge.\n* Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression.\n* Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.",[29,30,31,32,33],"Low Birth Weight","Kangaroo Mother Care","Postpartum Depression","Neurodevelopmental Outcome","Pre-Term",[35,30,36,37],"Low resource setting","Paternal depression","Cost-effectiveness","RECRUITING","2026-06-18",{"date":41,"type":42},"2026-06-22","ACTUAL",{"date":44,"type":42},"2024-12-01",{"date":46,"type":23},"2027-09-30",{"name":48,"class":49},"University of Alabama at Birmingham","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":18,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":24,"phases":62,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":50},"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).",true,"18 Years","50 Years",{"count":61,"type":23},240,[26],"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.",[31,65,66,67],"Mood Disorders","Anxiety Disorders","Postpartum Anxiety",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84],"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",{"date":87,"type":42},"2026-06-23",{"date":89,"type":23},"2028-06",{"date":91,"type":23},"2032-12",{"name":93,"class":49},"Weill Medical College of Cornell University",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":24,"phases":104,"briefSummary":106,"conditions":107,"keywords":113,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":50},"100642691","phase-4-intranasal-esketamine-dexmedetomidine-combination-and-postpartum-depression-100642691","NCT07639099","Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression","Impact of Intranasal Esketamine-dexmedetomidine Combination on Postpartum Depression in Parturients With Prenatal Depressive Symptoms: a Randomized, Double-blind, and Placebo-controlled Trial","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years who are preparing for childbirth;\n* Positive prenatal depression screening, defined as a Patient Health Questionnaire-9 (PHQ-9) score ≥5.\n\nExclusion Criteria:\n\n* History of schizophrenia or existence of communication barriers;\n* Severe obstetric complications, including severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placental abruption, or ASA physical status classification \\>III;\n* Contraindications to ketamine\u002Fesketamine, including refractory hypertension, severe cardiovascular disease (NYHA class ≥III), or hyperthyroidism;\n* Contraindications to dexmedetomidine, including severe bradycardia (heart rate \\\u003C50 bpm), or second-degree or higher atrioventricular block;\n* Unsuitable for intranasal administration due to nasal cavity diseases (e.g., rhinitis, nasal polyps, or nasal congestion of any cause);\n* Refusal to participate in this study or concurrent participation in another clinical trial.","FEMALE",{"count":103,"type":23},164,[105],"PHASE4","Esketamine has rapid-onset antidepressant effects and may reduce postpartum depression in parturients with prenatal depressive symptoms. However, its adverse neuropsychiatric symptoms limits clinical application. Dexmedetomidine can alleviate these adverse symptoms and has independent antidepressant effect. This randomized, double-blind, placebo-controlled trial is designed to evaluate whether intranasal esketamine combined with dexmedetomidine can reduce the prevalence of postpartum depression in women with prenatal depressive symptoms.",[108,109,110,111,112,31],"Parturients","Depressive Symptoms","Esketamine","Dexmedetomidine","Intranasal Administration",[108,114,110,111,115,116],"Prenatal depressive symptoms","Intranasal administration","Postpartum depression","2026-06-11",{"date":119,"type":42},"2026-06-15",{"date":121,"type":23},"2026-06",{"date":123,"type":23},"2029-12",{"name":125,"class":49},"Peking University First Hospital",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":57,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100639571","a-descriptive-study-of-the-correlation-between-postpartum-depression-and-body-image-dissatisfaction-self-objectification-and-social-media-appearance-comparison-100639571","NCT07603063","A Descriptive Study of the Correlation Between Postpartum Depression and Body Image Dissatisfaction, Self-objectification, and Social Media Appearance Comparison","Inclusion Criteria:\n\n1. Aged ≥ 18 years;\n2. Between 4 weeks and 12 months postpartum;\n3. Able to read and comprehend the Chinese questionnaire, and capable of using a smartphone;\n4. Voluntary participation in the study with a signed written informed consent form.\n\nExclusion Criteria:\n\n1. A confirmed pre-pregnancy diagnosis of psychiatric disorders or intellectual disabilities, preventing normal communication;\n2. Diagnosed with depression during pregnancy or the postpartum period, and currently receiving pharmacological or psychological therapy;\n3. Experiencing severe pregnancy or postpartum complications with an unstable clinical condition, rendering the participant unable to complete the questionnaire;\n4. Having a newborn with congenital malformations or severe medical conditions;\n5. Having experienced major stressful life events within the past 4 to 6 weeks (e.g., perinatal fetal death, or the death of an immediate family member).",{"count":133,"type":23},385,"OBSERVATIONAL","The goal of this observational study is to assess the prevalence of postpartum depression and analyze its relationship with body image dissatisfaction, self-objectification, and social media appearance comparison in postpartum women seeking care at the Obstetrics Department.\n\nThe main questions it aims to answer are:\n\nWhat is the current status of postpartum depression, body image dissatisfaction, and self-objectification in this population? How do body image dissatisfaction, self-objectification, and appearance-related social media comparison correlate with postpartum depression? Participants will answer online survey questions about their psychological status and social media usage.",[31],[31,138,139,140],"Body Image Dissatisfaction","Self-Objectification","Social Media Appearance Comparison","2026-05-20",{"date":143,"type":42},"2026-05-22",{"date":145,"type":23},"2026-04-28",{"date":147,"type":23},"2026-10-30",{"name":149,"class":49},"Sun Yat-sen University",{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":57,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":50},"100493100","the-rose-scale-up-study-informing-a-decision-about-rose-as-universal-ppd-prevention-100493100","NCT05700760","The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention","The ROSE Scale-up Study: Informing a Decision About ROSE as Universal Postpartum Depression Prevention","ROSES-II","Inclusion Criteria:\n\n1. Is aged 18 or older\n2. Is receiving prenatal services within the U.S\n3. Is between 12-32 weeks pregnant\n4. Speaks and understand English well enough to understand questionnaires when they are read aloud\n5. Has access to a telephone through owning one, a relative\u002Ffriend, or an agency\n6. Is willing and able to provide the name and contact information of at least two locator persons\n\nExclusion Criteria:\n\n1. Has a current major depressive episode\n2. Has current or past diagnosis of a bipolar disorder or a psychotic disorder",{"count":159,"type":23},2320,[26],"The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300\u002Fwoman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents \\~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.",[31],[69,164,165,166,167,168],"antenatal depression","depression","prevention","depression prevention","pregnancy","2026-05-14",{"date":171,"type":42},"2026-05-18",{"date":173,"type":42},"2023-06-01",{"date":175,"type":23},"2027-12-31",{"name":177,"class":49},"Michigan State University",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":101,"minAge":4,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":24,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":50},"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).",{"count":186,"type":23},384,[26],"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.",[31,67,190],"Cardiometabolic Syndrome",[192,193,194,195],"Postpartum","Mental Health","Cardiometabolic Health","Maternal-Infant Health","2026-05-12",{"date":169,"type":42},{"date":199,"type":42},"2024-06-27",{"date":201,"type":23},"2028-03-01",{"name":203,"class":49},"Ohio State University",{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":24,"phases":215,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":231,"leadSponsor":233,"locationsCount":50},"100633226","midwife-led-digital-follow-up-after-cesarean-section-100633226","NCT07523932","Midwife-Led Digital Follow-Up After Cesarean Section","The Effect of a Midwife-Led Digital Follow-Up Program on Postpartum Depression, Perceived Social Support, and Breastfeeding Self-Efficacy in Women After Cesarean Section: A Randomized Controlled Trial","MID-CS","Inclusion Criteria:\n\n* Women aged between 18 and 45 years\n* Women who have undergone cesarean section\n* Within the first 24 hours postpartum\n* Able to communicate in Turkish\n* Having a healthy singleton newborn\n* Willing to participate and provide informed consent\n\nExclusion Criteria:\n\n* History of psychiatric disorders\n* Presence of severe maternal complications\n* Newborn requiring intensive care unit admission\n* Women with communication difficulties\n* Participation in another intervention study","45 Years",{"count":214,"type":23},104,[26],"This randomized controlled trial aims to evaluate the effect of a midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section.\n\nParticipants will be randomly assigned to either an intervention group that will receive structured face-to-face education followed by a 4-week digital follow-up program, or a control group that will receive routine postpartum care.\n\nData will be collected at baseline (postpartum day 1), at 1 week, and at 4 weeks postpartum using validated measurement tools.\n\nThe study will provide evidence on the effectiveness of continuous, midwife-led digital support in improving maternal psychological well-being and breastfeeding outcomes in the early postpartum period.",[31,218,219],"Breastfeeding","Postpartum Period",[221,222,223,224,225,226],"Cesarean Section","Midwife-Led Intervention","Digital Follow-Up","Breastfeeding Self-Efficacy","Social Support","Postpartum Care","2026-04-13",{"date":229,"type":42},"2026-04-16",{"date":121,"type":23},{"date":232,"type":23},"2026-10",{"name":234,"class":49},"Inonu University",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":57,"sex":101,"minAge":242,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":24,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":50},"100506375","preventing-postpartum-depression-in-immigrant-latinas-100506375","NCT05873569","Preventing Postpartum Depression in Immigrant Latinas","Preventing Postpartum Depression Among Immigrant Latinas Though a Virtual Group Intervention","Inclusion Criteria:\n\n* Self-identify as Latina\n* Speak Spanish\n* Be at least 16 years old\n* Be pregnant or have a child \\\u003C9 months\n* Have access to a device they can use for MB-VG sessions.\n* Elevated depressive symptoms either scores of 5-14 on the Edinburgh Postnatal Depression Scale (EPDS) and\u002For scores 3.5 or greater prenatally or 4.5 or greater prenatally on the Postpartum Depression Predictors Inventory.\n\nExclusion Criteria:\n\n* Individuals who score \\>14 on the EPDS are exhibiting moderately severe to severe depressive symptoms and will be excluded given our prevention focus.\n* Individuals not at risk for PPD-i.e., EPDS scores \\\u003C5 and under the PDPI-R cutoff-will also be excluded.","16 Years",{"count":244,"type":23},300,[26],"Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and\u002For other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD.",[31],"2026-04-06",{"date":250,"type":42},"2026-04-09",{"date":252,"type":42},"2023-10-15",{"date":254,"type":23},"2027-04-30",{"name":256,"class":49},"Northwestern University",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":101,"minAge":264,"maxAge":212,"enrollmentInfo":265,"targetDuration":4,"studyType":24,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"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",{"count":266,"type":23},52,[26],"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.",[270,31,271],"Perinatal Depression","Mother-Infant Bonding Disorder",[273,116,274,275],"Perinatal depression","Mother-infant bonding","Yoga","2026-03-31",{"date":278,"type":42},"2026-04-07",{"date":280,"type":23},"2026-04-15",{"date":282,"type":23},"2027-05-15",{"name":284,"class":49},"All India Institute of Medical Sciences",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":57,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":24,"phases":294,"briefSummary":295,"conditions":296,"keywords":297,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},"100579010","implementation-of-a-clinical-decision-support-tool-for-postpartum-depression-100579010","NCT06818734","Implementation of a Clinical Decision Support Tool for Postpartum Depression","CDS","Inclusion Criteria:\n\n* 18 years or older\n* being seen at one of participating clinics\n* pregnancy at 20 week gestation or more\n\nExclusion Criteria:\n\n* Does not speak inclusion\n* does not have internet access\n\nClinician eligibility:\n\n* If they manage patients in the three clinics as a board-certified OBGYN clinician.\n* No exclusion criteria apply for clinician based on their knowledge and experience in treating PPD",{"count":293,"type":23},160,[26],"This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD).",[31],[298],"Clinical decision support tool","2026-03-30",{"date":301,"type":42},"2026-04-02",{"date":303,"type":23},"2026-05-01",{"date":305,"type":23},"2026-12-01",{"name":93,"class":49},3,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":57,"sex":18,"minAge":315,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":24,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":50},"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":317,"type":23},600,[26],"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.",[321,31,270],"Gestational Diabetes Mellitus",[323,321,270,31,324],"Antepartum Depression","Health Interventions","2026-03-19",{"date":327,"type":42},"2026-03-23",{"date":329,"type":42},"2023-10-26",{"date":331,"type":23},"2026-12-31",{"name":333,"class":49},"National Taiwan University Hospital",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":24,"phases":344,"briefSummary":345,"conditions":346,"keywords":349,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100545221","poor-sleep-during-pregnancy-as-risk-factor-for-post-partum-stress-and-mental-health-100545221","NCT06379074","Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health","Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health: A Translational, Longitudinal and Clinical Study. Maternal Outcome After THERapy for Sleep (MOTHERS)","MOTHERS","Inclusion Criteria:\n\n1. age ≥ 18 yrs. old;\n2. good knowledge of Italian language;\n3. intention to continue pregnancy;\n4. BMI ranging 18-30 (i.e., without underweight or obesity following international criteria; WHO, 2013);\n5. ≤ 15th week of pregnancy at the time of recruitment.\n\nExclusion Criteria:\n\n1. severe diagnosis of relevant somatic disorder;\n2. smoking;\n3. alcohol intake;\n4. assumption of illegal drugs;",{"count":343,"type":23},114,[26],"Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes.",[31,347,348],"Insomnia","Stress",[347,350,348,351,192,352,353,354,355],"Pregnancy","Sleep health","Actigraphy","Cortisol","DNA methylation","CBT-I","2026-02-26",{"date":358,"type":42},"2026-03-02",{"date":360,"type":42},"2024-05-06",{"date":362,"type":23},"2026-10-06",{"name":364,"class":49},"University of Rome G. Marconi",2,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":50},"100623579","a-long-term-study-of-patient-reported-changes-in-postpartum-depression-symptoms-in-people-starting-zuranolone-100623579","NCT07398469","A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone","A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use","Key Inclusion Criteria:\n\n* Participants with a prescription for zuranolone via Accredo Specialty Pharmacy.\n* Recent pregnancy in the last 12 months.\n* Confirmed diagnosis of PPD.\n* Able to complete the questionnaires by themselves in English.\n\nKey Exclusion Criteria:\n\n* Prior fill of zuranolone or brexanolone in last 12 months.\n* Participants who have taken 1 or more doses of zuranolone at the time of study screening.\n* Current or history of bipolar disorder.\n* Failure to complete baseline (Day 0) surveys.\n* Declined to consent.\n* Pregnancy that ended more than 12 months ago.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":374,"type":23},200,"In this study, researchers will learn how postpartum depression symptoms may change after people first start taking zuranolone. This is a drug available for doctors to prescribe for people with postpartum depression, also known as PPD. After giving birth, people with PPD can suffer from symptoms like tiredness, sadness, and a loss of interest in their daily activities.\n\nThis is known as an \"observational\" study, which collects health information about study participants without changing their medical care. Participants for this study will be found in the United States using a database from Accredo Specialty Pharmacy. This will include anyone who has a new prescription for zuranolone and were pregnant in the last 12 months before joining the study.\n\nThe main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be done using a questionnaire called the Edinburgh Postnatal Depression Scale, also known as the EPDS.\n\nThe main question that researchers want to answer is:\n\n• Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?\n\nResearchers will also learn about :\n\n* Changes in participants' EPDS scores at Day 45 and Day 90 in the study\n* Changes in EPDS scores at Day 15, Day 45, and Day 90 in a group of participants who have moderately severe PPD before starting zuranolone\n* How many participants breastfeed their babies while taking zuranolone\n* How many participants report not starting new medicine after finishing their zuranolone treatment\n\nThe study will be done as follows:\n\n* People with PPD who get a new zuranolone prescription through Accredo Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.\n* Before taking their first dose of zuranolone, participants will be asked to answer written questions about their symptoms using the online EPDS survey. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study.\n* Participants will then be asked to answer questions using the EPDS survey, 15 days, 45 days, and 90 days after taking the first dose of zuranolone. Each survey will take about 10-15 minutes to finish.",[31],"2026-02-04",{"date":379,"type":42},"2026-02-10",{"date":381,"type":42},"2025-12-22",{"date":383,"type":23},"2027-03-29",{"name":385,"class":386},"Biogen","INDUSTRY",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":57,"sex":101,"minAge":58,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":24,"phases":396,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":410,"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":395,"type":23},60,[26],"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.",[31,67],[400,401,165,402,403],"woman","postpartum","anxiety","mandala","2026-01-03",{"date":406,"type":42},"2026-01-07",{"date":408,"type":23},"2026-01-15",{"date":280,"type":23},{"name":411,"class":49},"Afyonkarahisar Health Sciences University",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":212,"enrollmentInfo":419,"targetDuration":4,"studyType":24,"phases":420,"briefSummary":421,"conditions":422,"keywords":423,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":50},"100613523","postpartum-1-day-cbt-pilot-study-trkiye-100613523","NCT07267702","Postpartum 1-Day CBT Pilot Study (Türkiye)","Cultural Adaptation of a One-Day Online Cognitive Behavioral Therapy Group Workshop for Postpartum Depression in Türkiye: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Female participants aged 18-45 years\n* Having an infant aged 1-12 months\n* Presence of clinically relevant postpartum depressive symptoms (EPDS ≥10)\n* Literate in Turkish (able to read and write)\n* Access to a stable internet connection\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Current psychotic, bipolar, organic mental, or substance use disorder\n* Severe depressive episode or impaired judgment due to psychiatric illness\n* Active suicidal ideation or intent\n* Medical or neurological condition preventing participation (e.g., dementia, intellectual disability, severe hearing or visual impairment)\n* Infant with a life-threatening congenital disorder",{"count":395,"type":23},[26],"This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effects of a culturally adapted, one-day online Cognitive Behavioral Therapy (CBT)-based group workshop for women with postpartum depression in Türkiye. The intervention was adapted from a validated model developed in Ontario, Canada, using Bernal's cultural adaptation framework.\n\nParticipants will be randomly assigned in a 1:1 ratio to either a workshop group, who will receive the one-day online CBT-based workshop within the first month after enrollment, or a control group who will continue to receive usual postpartum care throughout the study period. Data will be collected at baseline and at the 3-month follow-up using the Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), the Frequency of Actions and Thoughts Scale (FATS), and the TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ).\n\nThe study will assess feasibility indicators including recruitment, randomization procedures, completion of study questionnaires, retention through the 3-month follow-up, and adherence to the one-day workshop. Acceptability and preliminary changes in depressive, anxiety, and cognitive-behavioral outcomes will also be explored.\n\nThis pilot trial represents the first culturally adapted, one-day online CBT-based group intervention for postpartum depression in Türkiye and will inform the design of a future large-scale randomized controlled trial.",[31],[424,425,426,427,428,429,430,65,431,432,433],"Cognitive Behavioral Therapy","Online Intervention","Cultural Adaptation","Women, Gender and Mental Health","Feasibility Study","Randomized Controlled Trial","Psychotherapy","Depressive Disorder","Behavioral Disciplines and Activities","Depression, Postpartum","2025-11-25",{"date":436,"type":42},"2025-12-05",{"date":438,"type":23},"2025-12",{"date":440,"type":23},"2026-07",{"name":442,"class":49},"Marmara University",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":57,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":24,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":50},"100497921","understanding-the-role-of-doulas-in-supporting-people-with-pmads-100497921","NCT05763537","Understanding the Role of Doulas in Supporting People With PMADs","Inclusion Criteria:\n\n* Participants must be over the age of 18\n* Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment\n* Live in a HRSA-designated rural area of Montana\n\nExclusion Criteria:\n\n* They are under the age of 18\n* Not currently pregnant\n* Not between 13-26 gestational weeks at the time of enrollment\n* If they do not live in a HRSA-designated rural are of Montana.",{"count":450,"type":23},75,[26],"Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.",[454,350,455,456,225,193,457,31,458,459],"Maternal Health","Delivery, Obstetric","Self Efficacy","Substance-Related Disorders","Depression","Mental Health Services","2025-11-12",{"date":462,"type":42},"2025-11-14",{"date":464,"type":42},"2024-11-26",{"date":466,"type":23},"2026-07-31",{"name":468,"class":49},"University of Montana",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":101,"minAge":242,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":24,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":50},"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",{"count":477,"type":23},20,[26],"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.",[481,482,31,67],"Stress Disorders, Post-Traumatic","Premature Birth","2025-10-09",{"date":485,"type":42},"2025-10-14",{"date":487,"type":42},"2024-09-11",{"date":489,"type":23},"2027-08",{"name":491,"class":49},"University of Pennsylvania",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":101,"minAge":4,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":24,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":50},"100484217","engage--connect-a-psychotherapy-for-postpartum-depression-100484217","NCT05585164","Engage & Connect: A Psychotherapy for Postpartum Depression","Engage & Connect: A Novel Social Reward Psychotherapy for Postpartum Depression","Inclusion Criteria:\n\n1. Up to 1 year post-delivery\n2. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.\n3. Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks.\n4. Capacity to provide consent for research assessment and treatment.\n5. Speaks English proficiently\n\nExclusion Criteria:\n\n1. Intent or plan to attempt suicide in the near future\n2. Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)\n3. Active substance abuse or dependence\n4. Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy\n5. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia.\n6. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.",{"count":395,"type":23},[26],"This randomized controlled trial compares a novel psychotherapy, Engage \\& Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.",[31],"2025-09-22",{"date":505,"type":42},"2025-09-25",{"date":507,"type":42},"2022-11-01",{"date":509,"type":23},"2030-07",{"name":93,"class":49},{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":24,"phases":520,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":50},"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":519,"type":23},64,[26],"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.",[31,67,523],"Parental Stress",[116,525,526,527,528,529],"Postpartum anxiety","Parental stress","Mindfulness","Mindful with your baby","Mother-infant interaction","2025-09-15",{"date":532,"type":42},"2025-09-19",{"date":534,"type":42},"2023-07-01",{"date":536,"type":23},"2026-09",{"name":538,"class":49},"Tilburg University",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":57,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":549,"conditions":550,"keywords":558,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":50},"100599361","non-invasive-detection-of-iron-deficiency-in-obstetrics-100599361","NCT07083492","Non-invasive Detection of Iron Deficiency in Obstetrics","Point-of-care Transcutaneous Longitudinal Non-invasive Detection of Iron Deficiency in Obstetrics (PICCOLINO-Trial)","PICCOLINO","Inclusion Criteria:\n\n* any timepoint during or up to 3 months after pregnancy\n* age ≥ 18 years\n* written informed consent\n\nExclusion Criteria:\n\n* previous participation in this study\n* refusal of blood sampling\n* incapacity to give informed consent",{"count":548,"type":23},500,"Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy.\n\nIn addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.",[551,552,553,554,555,31,556,557],"Iron Deficiency Anemia of Pregnancy","Iron-deficiency","Restless Leg Syndrome in Pregnancy","Restless Leg Syndrome Due to Iron Deficiency Anaemia","Postpartum Hemorrhage","Pregnancy Anemia","Iron Deficiency (Without Anemia)",[559,560,561,562],"Zinc protoporphyrin","Non-invasive detection","Obstetric anesthesia","Patient blood management","2025-07-23",{"date":565,"type":42},"2025-07-24",{"date":567,"type":42},"2022-11-15",{"date":331,"type":23},{"name":570,"class":49},"Wuerzburg University Hospital",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":24,"phases":580,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":365},"100446757","rct-of-at-home-tdcs-for-depression-in-pregnancy-100446757","NCT05097586","RCT of At-Home tDCS for Depression in Pregnancy","Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy","Inclusion criteria:\n\n1. Adult, ≥18 years of age\n2. Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization\n3. In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)\n4. Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use\n5. No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment\n\nExclusion criteria:\n\n1. Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS\n2. Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)\n3. Bipolar disorder as assessed by MINI International Neuropsychiatric Interview\n4. Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview\n5. Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia\u002Feclampsia in current pregnancy or neurologic illness or seizure history\n6. Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI\u002FCo-I assessment)\n7. Metal implants in cranium or any electrical implants\n8. Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS\n9. Visibly non-intact skin\u002Frash on scalp areas at stimulation electrode sites\n10. Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English",{"count":579,"type":23},156,[26],"This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum",[583,350,31],"Major Depression",[350,458,585],"Transcranial direct current stimulation","2025-05-21",{"date":588,"type":42},"2025-05-28",{"date":590,"type":42},"2021-11-08",{"date":592,"type":23},"2027-06",{"name":594,"class":49},"Women's College Hospital",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":24,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":50},"100491268","maternal-well-being-in-the-postnatal-stage-100491268","NCT05676918","Maternal Well-being in the Postnatal Stage","Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention","BIEMAT","Inclusion Criteria:\n\n* Women who have been mothers in the last year\n\nExclusion Criteria:\n\n* Women who have been mothers in the last month,\n* Women who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for substance abuse and\u002For dependence within 30 days prior to study participation,\n* Women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).",{"count":604,"type":23},98,[26],"The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.",[31,608],"Postpartum Disorder","2025-05-16",{"date":586,"type":42},{"date":612,"type":42},"2023-01-16",{"date":614,"type":23},"2026-03-01",{"name":616,"class":49},"Universidad Complutense de Madrid",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":101,"minAge":58,"maxAge":59,"enrollmentInfo":624,"targetDuration":4,"studyType":24,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":50},"100425559","maternal-stress-on-human-milk-and-infant-outcomes-100425559","NCT04821544","Maternal Stress on Human Milk and Infant Outcomes","Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes","Inclusion Criteria:\n\n* Mothers of newborn infants at Kootenai Health NICU and the Palouse region\n\nExclusion Criteria:\n\n\\-",{"count":548,"type":23},[26],"The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.",[31,628],"Preterm Labor",[630,527,631,632,633,634],"Maternal stress","Human milk bioactives","Infant metabolome","Maternal transcriptome","Infant transcriptome",{"date":636,"type":42},"2025-05-18",{"date":638,"type":42},"2021-05-01",{"date":640,"type":23},"2027-06-30",{"name":642,"class":49},"University of Idaho",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":649,"eligibilityCriteria":650,"healthyVolunteers":57,"sex":18,"minAge":58,"maxAge":59,"enrollmentInfo":651,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":653,"conditions":654,"keywords":656,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":50},"100551634","contact-relationship-in-neonatal-intensive-care-unit-100551634","NCT06462638","COntact RElationship in Neonatal Intensive Care Unit","Study on the Developmental Value of the Physical and Vocal Contact Relationship Between Preterm Infant in the NICU and Caregivers (Mother, Father, Nurse)","CORE in NICU","Inclusion Criteria:\n\n* For infants: Infants with gestational age between 33 and 36 weeks, weighing around 2kg (LBW - low birth weight), in whom life-threatening conditions have been averted and in stable medical condition will be included in the study.\n* For parents: Male and female adults aged between 18 and 50 years.\n\nExclusion Criteria:\n\n* For infants: Presence of congenital anomalies, neurological disorders, genetic syndromes, and any other condition of developmental atypicality.\n* For parents: Parents under 18 years of age; Parents with diagnosed psychiatric disorders and\u002For sensory disabilities; single parents.",{"count":652,"type":23},80,"The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the neurobehavioral states of the infant in response to maternal and paternal voice.\n\nThe study is aimed at furthering the still underdeveloped knowledge regarding the possible effects of the paternal voice on the neurobehavioral states of the preterm infant in the crib, comparing them with the effects of exposure to the maternal voice and the voice of a familiar but non-parental figure, such as the NICU nurse.\n\nThese behavioral states will also be observed as a function of the psychological condition of the parents, investigating the presence of a possible postpartum depressive condition and\u002For anxiety of the mother and symptomatology attributable to perinatal affective disorders in the fathers, which are often overlooked; and again, the neurobehavioral responses of the infants will be correlated with the neurophysiological responses of the parents\u002Fnurses who interact with them through voice and touch.\n\nThe research aims to have a direct impact on both parents and health care personnel: in addition to questionnaires dedicated to screening parents for perinatal psychological disorders, artificial intelligence systems will be used to intercept possible postpartum depression early by recording the maternal voice, enabling the activation of a psychological support intervention and reducing the negative impact that a postpartum depression has on the early mother-child relationship. In addition, information on parent-child interactive modalities will be able to further guide the intake of assignment and particularly the accompaniment of parents during the time of hospitalization.",[655,31],"Preterm Birth",[657,658,69],"preterm birth","contact relationship","2025-04-29",{"date":661,"type":42},"2025-05-01",{"date":663,"type":42},"2024-11-01",{"date":665,"type":23},"2026-10-31",{"name":667,"class":49},"Istituto per la Ricerca e l'Innovazione Biomedica",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":674,"eligibilityCriteria":675,"healthyVolunteers":57,"sex":101,"minAge":58,"maxAge":212,"enrollmentInfo":676,"targetDuration":4,"studyType":24,"phases":678,"briefSummary":679,"conditions":680,"keywords":686,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":696,"locationsCount":50},"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.",{"count":677,"type":23},342,[26],"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.",[31,67,681,682,683,684,685],"Sleep Disturbance","Infant Behavior","Maternal Behavior","Inflammation","Military Family",[687,401,688,689,165,402],"sleep","intervention","inflammation","2025-02-06",{"date":692,"type":42},"2025-02-10",{"date":694,"type":42},"2025-01-15",{"date":89,"type":23},{"name":697,"class":49},"University of Colorado, Colorado Springs"]