[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551147":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":44,"responsibleParty":65,"collaborators":67,"id":71,"slug":12,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":12,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Kenyatta National Hospital","OTHER_GOV",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm: Enhanced Standard of care","NO_INTERVENTION","Control facilities will provide enhanced standard of care. The enhanced standard of care will include two enhancements:\n\n1. HIV Testing Services (HTS) providers and lay workers will conduct screening for perinatal mood and anxiety disorders (PMAD) using the PHQ-2 and GAD-2.\n2. The study team will provide a PMAD referral information sheet to all control facilities describing inpatient and outpatient psychiatry services at the nearby referral hospitals",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention arm: Integrated Perinatal Mental Health Program (IPMH)","EXPERIMENTAL","Intervention facilities will receive the Integrated Perinatal Mental Health Program (IPMH). This includes:\n\n1. Systematic screening for PMAD symptoms using PHQ-2 and GAD-2. Positive screeners (PHQ-2≥3 and\u002For GAD-2≥3) will then be referred to nurses to administer additional screening by PHQ-9 and GAD-7\n2. Non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) delivered weekly\n3. In-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to Problem Management+",[18],"Behavioral: Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)","The intervention includes systematic screening for PMAD symptoms using PHQ-2 and GAD-2, non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) and in-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to PM+",[14],[26,29,32],{"name":27,"affiliation":5,"role":28},"John Kinuthia, MBChB, MMed, MPH","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Keshet Ronen, MPH, PhD","University of Washington",{"name":33,"affiliation":31,"role":28},"Amritha Bhat, MBBS, MD, MPH",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":12,"email":39},"Nancy Ngumbau, MBChB, MPH","CONTACT","+254713917226","nancym390@gmail.com",{"name":41,"role":37,"phone":42,"phoneExt":12,"email":43},"Agnes Karume, MBChB, MPH","+254715181283","karumeagnes@gmail.com",[45,60],{"facility":5,"status":46,"city":47,"state":12,"zip":12,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Nairobi","Kenya",{"type":50,"coordinates":51},"Point",[52,53],36.81667,-1.28333,{"lat":53,"lon":52},[56,59],{"name":27,"role":37,"phone":57,"phoneExt":12,"email":58},"+254722799052","kinuthia@uw.edu",{"name":27,"role":28,"phone":12,"phoneExt":12,"email":12},{"facility":61,"status":46,"city":62,"state":12,"zip":12,"country":48,"cosmosGeoPoint":12,"geoPoint":12,"contacts":63},"HomaBay, Siaya and Kisumu","Western Kenya",[64],{"name":27,"role":37,"phone":57,"phoneExt":12,"email":58},{"type":66,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[68],{"name":69,"class":70},"National Institute of Mental Health (NIMH)","NIH","100551147",false,"NCT06456307","Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics","IPMH","Inclusion Criteria:\n\n* Pregnant and ≥28 weeks gestation\n* Attending ANC care at the facility\n* ≥14 years old\n* Screen positive for PMAD symptoms (PHQ-2≥3 and\u002For GAD-2≥3)\n* Willing to return to the MCH and PMTCT clinic for study visits\n\nExclusion Criteria:\n\n* Less than 28 weeks gestation\n* Any woman at high risk of self-harm based on a study self-harm assessment protocol,\n* Has cognitive impairments or psychotic symptoms",true,"FEMALE","14 Years",{"count":81,"type":82},2970,"ESTIMATED","INTERVENTIONAL",[85],"NA","Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.",[88,89,90],"Depression, Anxiety","Antenatal Depression","Postnatal Depression",[92,93,94,95,96,97,98,99],"perinatal mood and anxiety disorders","telepsychiatry","Problem management plus","Integrated Perinatal Mental Health","Pregnancy","Postpartum","Depression","Anxiety","2025-12-03",{"date":102,"type":103},"2025-12-10","ACTUAL",{"date":105,"type":103},"2025-02-17",{"date":107,"type":82},"2028-03",{"name":5,"class":6},2]