[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659601":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":29,"interventions":29,"overallOfficials":35,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":29,"enrollmentInfo":84,"targetDuration":29,"studyType":87,"phases":29,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":99,"whyStopped":29,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Hawaii","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":29},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Clinically Significant Depression Score Assessed by EPDS","An Edinburgh Postnatal Depression Scale (EPDS) score \\>= 11 will indicate a clinically significant depression score (Levis et al., 2020, BMJ).","Anytime between baseline and 6 months postpartum",{"measure":14,"description":15,"timeFrame":12},"Alternate Metric for Clinically Significant Depression Score Assessed by EPDS","An Edinburgh Postnatal Depression Scale (EPDS) score \\>= 13 will be an alternative metric for clinically severe depression score (Levis et al., 2020, BMJ).",{"measure":17,"description":18,"timeFrame":12},"Clinically Significant Anxiety Score Assessed by GAD-7","GAD-7 Score \\>= 10 (Solomonov et al., 2025, JAMA Network Open)",{"measure":20,"description":21,"timeFrame":12},"Alternate Metric for Clinically Significant Anxiety Score Assessed by GAD-7","GAD-7 score \\>= 13 will be an alternate threshold for determining clinically significant anxiety symptoms (Simpson et al., 2014, Canadian Journal of Psychiatry)",[23,26],{"measure":24,"description":25,"timeFrame":12},"Clinically Significant Change in EPDS Scores","Change of \\>= 4 between EPDS scores will indicate a clinically significant change (Matthey, 2004, Journal of Affective Disorders)",{"measure":27,"description":28,"timeFrame":12},"Clinically Significant Change in GAD-7 Scores","Change of greater than 3 on the GAD-7 (Stefana et al., 2026, Anxiety Disorders)",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","Mental health conditions are the leading cause of perinatal death in the United States, accounting for more than one-quarter of pregnancy-related deaths. Perinatal depression is particularly common, with up to 28% of postpartum individuals meeting criteria for clinically significant depression.\n\nObjective, noninvasive biomarkers, particularly from wearables (e.g., Apple Watch), can passively measure sleep, activity, heart rate, and oxygen saturation, avoiding reporting bias and revealing underlying physiology. However, empirical evidence for wearable-based detection of postpartum depression is lacking, and it remains unclear whether individual variation in changing normative health metrics can be used to remotely monitor common mental health concerns, such as postpartum depression.\n\nTo address these gaps, the project proposes a fully remote study in Hawai'i, where geographic and access barriers are high. This project will enroll 100 women within 2 months postpartum and following them to 6 months, and collect Apple Watch metrics and weekly depression\u002Fanxiety symptom ratings. Practical AI\u002Fmachine learning approaches will be designed to automatically process and analyze the large-scale wearable data, enabling the efficient integration of complex, time-varying signals, effective detection of subtle deviations, and accurate prediction of depressive episodes.\n\nBy integrating wearable-derived biometrics, weekly symptom tracking, and AI\u002FML prediction models, this study aims to identify digital biomarkers of postpartum depression and anxiety. These findings may support earlier screening, personalized monitoring, and timely referral for perinatal mental health care in Hawai'i and beyond, especially helping people living in rural areas and on neighbor islands, given that Hawai'i is classified as a state with low access to mental healthcare.","We will recruit postpartum women across the Hawaiian Islands who have given birth within the last 2 months.",[36,40],{"name":37,"affiliation":38,"role":39},"Cassandra L Hendrix, PhD","University of Hawai'i at Mānoa","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":38,"role":39},"Yifan Wang, PhD",[43],{"name":44,"role":45,"phone":46,"phoneExt":29,"email":47},"Zoë Barron","CONTACT","(805) 242-8408","reeflab@hawaii.edu",[49],{"facility":38,"status":29,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Honolulu","Hawaii","96822","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-157.85833,21.30694,{"lat":59,"lon":58},[62,64,65],{"name":44,"role":45,"phone":63,"phoneExt":29,"email":47},"805-242-8408",{"name":37,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":41,"role":39,"phone":29,"phoneExt":29,"email":29},{"type":39,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Yifan Wang","Assistant Professor",[70],{"name":71,"class":72},"Apple Inc.","INDUSTRY","100659601","hawaii-postpartum-onset-depression-study-100659601",false,"NCT07866053","Hawai'i Postpartum Onset Depression Study","AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety","POD","Inclusion Criteria:\n\n* Be at least 18 years old;\n* Be within two months after giving birth at the time of enrollment;\n* Live in Hawai'i;\n* Have access to an iPhone that is compatible with the study-specific iOS application and Apple Watch;\n* Be able to understand the study information and provide informed consent; and\n* Be able to read and complete study procedures in English.\n\nExclusion Criteria:\n\n* Less than 18 years old;\n* Has not given birth within the past 2 months;\n* Does not live in Hawai'i;\n* Does not have access to a study-compatible iPhone;\n* Cannot understand study information and provide informed consent; or\n* Cannot read or complete study procedures in English.",true,"FEMALE","18 Years",{"count":85,"type":86},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to examine whether passively collected wearable data can be used to predict onset and severity of postpartum depression and anxiety symptoms. The main questions it aims to answer are:\n\n1. When do depression and anxiety symptoms emerge, worsen, and improve across the first 6 months postpartum?\n2. Can machine learning\u002Fartificial intelligence models prospectively predict clinically significant depression symptoms using Apple Watch metrics?\n\nWomen who have given birth within the past 2 months and who live in Hawai'i will be eligible for the study. Participants will wear an Apple Watch and answer weekly online survey questions until they reach 6 months postpartum. The study is designed to be fully remote to maximize accessibility across the Hawaiian Islands.",[90,91],"Postpartum Depression (PPD)","Postpartum Anxiety",[93,94,95,96,97,98],"postpartum depression","postpartum anxiety","wearables","Apple Watch","artificial intelligence","machine learning","NOT_YET_RECRUITING","2026-10-07",{"date":102,"type":103},"2026-10-08","ACTUAL",{"date":105,"type":86},"2026-12-01",{"date":107,"type":86},"2027-12",{"name":5,"class":6},1]