[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551147":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":44,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":12,"enrollmentInfo":82,"targetDuration":12,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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",[45,61],{"facility":5,"status":46,"city":47,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Nairobi","Kenya","KE",{"type":51,"coordinates":52},"Point",[53,54],36.81667,-1.28333,{"lat":54,"lon":53},[57,60],{"name":27,"role":37,"phone":58,"phoneExt":12,"email":59},"+254722799052","kinuthia@uw.edu",{"name":27,"role":28,"phone":12,"phoneExt":12,"email":12},{"facility":62,"status":46,"city":63,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":12,"geoPoint":12,"contacts":64},"HomaBay, Siaya and Kisumu","Western Kenya",[65],{"name":27,"role":37,"phone":58,"phoneExt":12,"email":59},{"type":67,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[69],{"name":70,"class":71},"National Institute of Mental Health (NIMH)","NIH","100551147","integration-of-stepped-care-for-perinatal-mood-and-anxiety-disorders-among-women-attending-mch-clinics-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":83,"type":84},2970,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90,91,92],"Depression, Anxiety","Antenatal Depression","Postnatal Depression",[94,95,96,97,98,99,100,101],"perinatal mood and anxiety disorders","telepsychiatry","Problem management plus","Integrated Perinatal Mental Health","Pregnancy","Postpartum","Depression","Anxiety","2025-12-03",{"date":104,"type":105},"2025-12-10","ACTUAL",{"date":107,"type":105},"2025-02-17",{"date":109,"type":84},"2028-03",{"name":5,"class":6},2]