[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652499":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":22,"locations":31,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":11,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"University of Kansas Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive behavioral therapy for insomnia (CBT-I)","EXPERIMENTAL",null,[13],"Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)",{"label":15,"type":16,"description":11,"interventionNames":11},"Treatment As Usual (TAU)","NO_INTERVENTION",[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":11},"BEHAVIORAL","The CBT-I program is a 1x\u002Fweek, 6-week one-one-one program via video conferencing with trained research personnel. The program is based on standard CBT-I manuals.",[9],[23,28],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Catherine Siengsukon, PT, PHD","CONTACT","913-588-6913","csiengsukon@kumc.edu",{"name":29,"role":25,"phone":11,"phoneExt":11,"email":30},"Jade Robichaud","jrobichaud@kumc.edu",[32],{"facility":33,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University of Kansas Medical Center- Sleep, Health and Wellness Laboratory","Kansas City","Kansas","66160","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-94.62746,39.11417,{"lat":43,"lon":42},[46],{"name":29,"role":25,"phone":11,"phoneExt":11,"email":30},{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100652499","phase-1-early-cognitive-behavioral-therapy-for-insomnia-cbt-i-in-people-planning-to-under-hematopoietic-stem-cell-transplant-hsct-100652499",false,"NCT07774039","Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)","Feasibility, Acceptability, and Preliminary Treatment Efficacy of Early Cognitive Behavioral Therapy for Insomnia (CBT-I) to Mitigate Insomnia Symptoms and Fatigue and Improve Health-related Quality of Life in Individuals Planning to Undergo Hematopoietic Stem Cell Transplant (HSCT)","Inclusion Criteria:\n\n* ≥18 years old\n* ≥10 on Insomnia Severity Index\n* Primary HSCT physician approval\n* English speaking\n\nExclusion Criteria:\n\n* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)\n* \\>3 on STOP BANG indicating increased risk of sleep apnea\n* Increased risk of Restless legs syndrome as determined by RLS-Diagnosis Index\n* Parasomnia as determined by the Sleep Disorders-Revised\n* If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \\\u003C 3 months or dose has changed in past 3 months\n* T-score ≥70 on PROMIS 29+2 Anxiety or PROMIS 29+2 Depression domains indicating moderate\u002Fsevere anxiety or depression\n* Current or history (up to 2 years) of substance use disorder involving drugs or alcohol as defined by DSM-5-TR criteria\n* History of other nervous system disorder such as stroke or Parkinson's disease\n* Severe mental illness such as schizophrenia or bipolar disorder\n* Severe neurological or sensory impairments that would interfere significantly with testing\n* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am\n* Currently receiving a behavioral sleep health intervention or other behavioral health interventions that may impact sleep (such as exercise, mindfulness, CBT)","ALL","18 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","This proposed study is a prospective, randomized, controlled Phase 1 clinical trial to determine feasibility, acceptability (Aim 1) and preliminary effect (Aim 2) to mitigate insomnia symptoms and fatigue and improve health-related quality of life in patients who are planning to undergo HSCT. The investigators plan to enroll n=30 with insomnia symptoms (Insomnia Severity Index ≥10) who will be randomized into one of two groups: 1. A group that starts CBT-I after the initial evaluation visit with the HSCT care team (Early CBT-I), or 2. Treatment as usual (TAU). Participants in the CBT-I group will receive six sessions of telehealth-delivered CBT-I that is completed prior to transplant. Reassessments will occur post-intervention (\\~1-2 weeks before HSCT) and 1- and 3-months post-HSCT.",[66],"Hematopoietic Stem Cell Transplant","NOT_YET_RECRUITING","2026-08-14",{"date":70,"type":71},"2026-08-19","ACTUAL",{"date":73,"type":60},"2026-09-08",{"date":75,"type":60},"2027-06-30",{"name":5,"class":6},1]