[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627054":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":31,"locations":31,"responsibleParty":32,"collaborators":34,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":31,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":31,"enrollmentInfo":46,"targetDuration":31,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":61,"whyStopped":31,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":31},{"fullName":5,"class":6},"SRI International","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital cognitive behavioral therapy for insomnia","EXPERIMENTAL","An automated digital CBT-I program, delivered in 6 modules at least one week apart.",[13],"Behavioral: digital cognitive behavioral therapy for insomnia",{"label":15,"type":16,"description":17,"interventionNames":18},"Digital sleep hygiene education","ACTIVE_COMPARATOR","A digital sleep hygiene intervention delivered in 6 modules, at least one week apart.",[19],"Behavioral: Digital sleep hygiene education",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","digital cognitive behavioral therapy for insomnia","A digital CBT-I program that includes stimulus control, sleep restriction therapy, and cognitive therapy",[9],[27],"dCBT-I",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"A digital sleep hygiene education intervention that includes recommendations about environmental and behavioral factors that can support healthy sleep.",[15],null,{"type":33,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[35],{"name":36,"class":37},"Stanford University","OTHER","100627054","targeting-insomnia-to-prevent-depression-in-the-menopause-transition-100627054",false,"NCT07443644","Targeting Insomnia to Prevent Depression in the Menopause Transition","Inclusion Criteria:\n\n1. At least 40 years old and in the perimenopause,\n2. Willingness to participate in a digital research protocol,\n3. Current moderate to severe insomnia symptoms that started or worsened in association with perimenopause,\n4. English fluency.\n\nExclusion Criteria:\n\n1. Current major depressive disorder\n2. Existing diagnosis of a sleep disorder other than insomnia\n3. Experiencing excessive daytime sleepiness\n4. Having received CBT-I in the preceding 6 months\n5. Severe psychiatric or medical conditions or medications that could compromise safe participation in the study or interfere with the scientific aims\n6. Hysterectomy and\u002For bilateral ovariectomy or current hormonal therapy,\n7. Night shift worker","FEMALE","40 Years",{"count":47,"type":48},230,"ESTIMATED","INTERVENTIONAL",[51],"NA","This randomized clinical trial is focused on perimenopausal women who have difficulty sleeping. It will randomize digital cognitive behavioral therapy for insomnia (dCBT-I) or a sleep hygiene intervention (SHI). After treatment, participants will be assessed every 3-months over a 2-year period.\n\nThe two main questions the study aims to answer are:\n\n1. Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation?\n2. Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?",[54,55],"Insomnia","Menopause Related Conditions",[57,58,59,60],"menopause","hot flashes","cognitive behavioral therapy for insomnia","insomnia","NOT_YET_RECRUITING","2026-02-23",{"date":64,"type":65},"2026-03-02","ACTUAL",{"date":67,"type":48},"2026-09",{"date":69,"type":48},"2031-02",{"name":5,"class":6}]