[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411062":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of South Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia","EXPERIMENTAL","This is a pilot trial with one treatment condition (CBT-I).",[13],"Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)","Participants will complete 4 web-based CBT- I sessions. Lesson 1: Sleep Hygiene and Stimulus Control Lesson 2: Sleep Restriction and Relaxation Strategies Lesson 3: Identifying and Restructuring Dysfunction Thoughts Lesson 4: Practical Recommendations, Review, and Maintenance of Change",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Christina McCrae","University of Missouri-Columbia","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Christina S McCrae","CONTACT","573-882-0982","mccraec@health.missouri.edu",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Riley Stephens","573-882-8881","rstephens@health.missouri.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of Missouri","RECRUITING","Columbia","Missouri","65212","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-92.33407,38.95171,{"lat":49,"lon":48},[52,53],{"name":23,"role":29,"phone":20,"phoneExt":20,"email":20},{"name":33,"role":29,"phone":20,"phoneExt":20,"email":20},{"type":25,"investigatorFullName":23,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Professor","100411062","web-based-cognitive-behavioral-treatment-for-insomnia-in-dementia-caregivers-100411062",false,"NCT04632628","Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers","NiteCAPP","CAREGIVER\n\nInclusion Criteria:\n\n* 18+ yrs\n* Dementia caregiver living with person with dementia\n* willing to be randomized, 4. read\u002Funderstand English\n* insomnia diagnosis\n* no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.\n\nInsomnia:\n\n* complaints for 6+ mos\n* adequate opportunity and circumstances for sleep\n* 1+ of the following: difficulty falling asleep, staying asleep, or waking too early\n* daytime dysfunction (mood, cognitive, social, occupational) due to insomnia\n* Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10\n* baseline diaries indicate \\>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.\n\nExclusion Criteria:\n\n* unable to consent\n* cognitive impairment \\[Telephone Interview for Cognitive Status (TICS) \\\u003C25 or Mini Mental State Examination (MMSE) \\\u003C26\\]\n* sleep disorder other than insomnia \\[i.e., sleep apnea (apnea\u002Fhypopnea index, AHI \\>15)\\]\n* bipolar or seizure disorder\n* other major psychopathology except depression or anxiety (e.g., suicidal ideation\u002Fintent, psychosis)\n* severe untreated psychiatric comorbidity\n* psychotropic or other medications (e.g., beta-blockers) that alter sleep\n* non-pharmacological tx for sleep or mood outside current trial.\n\nPERSONS WITH DEMENTIA\n\nInclusion Criteria:\n\n* 18+ yrs\n* Persons with dementia living with caregiver\n* Have an eligible caregiver\n* willing to be randomized\n\nExclusion Criteria:\n\n• Person with dementia or legally authorized representative is unable to consent",true,"ALL","18 Years",{"count":67,"type":68},60,"ESTIMATED","INTERVENTIONAL",[71],"NA","Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia.\n\nObjectives\n\n1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.\n2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.\n3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.\n4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).",[74,75],"Insomnia Chronic","Dementia",[77,78,79,80,81,75],"Dementia Caregiver","Sleep","Behavioral Interventions","Online Behavioral Intervention","Insomnia","2026-06-11",{"date":84,"type":85},"2026-06-15","ACTUAL",{"date":87,"type":85},"2023-11-14",{"date":89,"type":68},"2027-09-30",{"name":5,"class":6},1]