[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549155":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":68,"collaborators":25,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Henry Ford Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)","EXPERIMENTAL","PUMAS is a clinician-administered psychotherapy intervention for prenatal insomnia that includes six weekly 60-minute sessions in an individual format. PUMAS combines behavioral sleep strategies with mindfulness exercises and tailors all components to pregnancy to improve sleep quality. PUMAS will be delivered via telemedicine video.",[13],"Behavioral: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment-as-usual (TAU)","ACTIVE_COMPARATOR","TAU reflects real-world care where patients and their providers make their own treatment decisions for treating prenatal insomnia. Common TAU options include over-the-counter sleep aids, sleep hygiene education, melatonin, and cognitive-behavioral therapy for insomnia. The TAU group will be well-characterized (i.e., the investigators will monitor interventions administered by the usual care providers and collect information on dosage, frequency, duration, adherence) to best describe treatment options sought and completed in the real world.",[19],"Other: Treatment-as-usual (TAU)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Mindfulness-based sleep program for pregnant women.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Usual practices from real-world care experiences.",[15],[30],"Usual care practice",[32],{"name":33,"affiliation":34,"role":35},"David A Kalmbach, PhD","Henry Ford Health","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":25,"email":40},"CONTACT","248-325-3938","dkalmba1@hfhs.org",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Christopher L Drake, PhD","248-344-6672","cdrake1@hfhs.org",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Henry Ford Medical Center","RECRUITING","Novi","Michigan","48377","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-83.47549,42.48059,{"lat":58,"lon":57},[61,65],{"name":62,"role":38,"phone":63,"phoneExt":25,"email":64},"David Kalmbach, PhD","2483253938","dkalmbach1@hfhs.org",{"name":66,"role":38,"phone":25,"phoneExt":25,"email":67},"Heba Afaneh, MA","hafaneh1@hfhs.org",{"type":35,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"David Kalmbach","Associate Scientist","100549155","phase-2-sleep-to-reduce-incident-depression-effectively-in-peripartum-100549155",false,"NCT06430333","Sleep to Reduce Incident Depression Effectively in Peripartum","STRIDE P","Inclusion Criteria:\n\n1. Singleton pregnancy, gestational week 14-31 at screening.\n2. DSM-5 Insomnia Disorder (≥1 month duration).\n3. Insomnia Severity Index (ISI) score ≥ 11.\n4. Edinburgh Postnatal Depression Scale score\\\u003C13 at screening.\n5. No current DSM-5 Major Depression.\n6. Reliable internet access for treatment and assessments.\n7. Not currently engaged in therapy for major depression or insomnia disorder.\n8. Age 18 years or older.\n\nExclusion Criteria:\n\n1. High risk pregnancy (pre-eclampsia, placenta previa w\u002F hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed).\n2. Active suicidal intent.\n3. Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.\n4. Untreated RLS (treated RLS is OK).\n5. Excessive daytime sleepiness; Epworth Sleepiness Scale\\>15.\n6. Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).","FEMALE","18 Years",{"count":81,"type":82},500,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","Perinatal depression (PND) is the most common complication in pregnancy and postpartum, which increases risk for adverse perinatal outcomes such as preterm birth, maternal suicidal thoughts, and impaired mother-infant bonding. Insomnia often precedes PND cases and may serve as an entry point for interventions preventing PND. The proposed project is a large-scale clinical trial to test the effectiveness of a mindfulness-based sleep program designed for pregnant women to improve sleep and alleviate cognitive arousal to reduce risk for PND across pregnancy and postpartum.",[88,89],"Insomnia","Depression",[91,92,93,94,95],"pregnancy","postpartum","sleep","worry","rumination","2026-04-14",{"date":98,"type":99},"2026-04-17","ACTUAL",{"date":101,"type":99},"2024-12-10",{"date":103,"type":82},"2028-02-29",{"name":5,"class":6},1]