[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431337":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":39,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":39,"enrollmentInfo":70,"targetDuration":39,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":43,"whyStopped":39,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of South Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NiteCAPP CARES","EXPERIMENTAL","Cognitive Behavioral Treatment-Insomnia. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on sleep education, sleep hygiene, and stimulus control. Session 2 focuses on sleep compression, relaxation, and problem solving. Session 3 focuses on coping and stress management and cognitive therapy. Session 4 focuses on a review of skills and plan for maintenance of behavior change.",[13],"Behavioral: NiteCAPP CARES",{"label":15,"type":10,"description":16,"interventionNames":17},"NiteCAPP SHARES","Sleep Hygiene and Related Education. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on expanded sleep education and sleep hygiene. Session 2 focuses insomnia education and sleep hygiene support. Session 3 focuses on targeted sleep education and sleep in dementia. Session 4 focuses on a review of skills and plan for maintenance of behavior change. Boosters review skills, encourage practice, and troubleshoot issues.",[18],"Behavioral: NiteCAPP SHARES",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on sleep education, sleep hygiene, and stimulus control. Session 2 focuses on sleep compression, relaxation, and problem solving. Session 3 focuses on coping and stress management and cognitive therapy. Session 4 focuses on a review of skills and plan for maintenance of behavior change.",[9],[25],"Web CBT-I",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on expanded sleep education and sleep hygiene. Session 2 focuses insomnia education and sleep hygiene support. Session 3 focuses on targeted sleep education and sleep in dementia. Session 4 focuses on a review of skills and plan for maintenance of behavior change. Boosters review skills, encourage practice, and troubleshoot issues.",[15],[30],"Web Sleep Hygiene and Related Education (Web-SHARE)",[32],{"name":33,"affiliation":5,"role":34},"Christina S McCrae","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","813-974-1804",null,"christinamccrae@usf.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-82.45843,27.94752,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":38,"phoneExt":39,"email":40},"Christina McCrae",{"type":59,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100431337","nitecapp-web-based-interventions-for-insomnia-in-rural-dementia-caregivers-100431337",false,"NCT04896775","NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers","NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes","NiteCAPP","Inclusion:\n\nCaregiver Eligibility. Inclusion criteria: 1. 18+ yrs, 2. CG living with PWD, 3. willing to be randomized, 4. read\u002Funderstand English, 5. insomnia diagnosis, 6. no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos.\n\n* Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances for sleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking too early, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 5. baseline diaries indicate \\>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.\n\nPWD Eligibility. 1. probable\u002Fpossible Alzheimer's Disease (self-report or primary care provider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts\u002Fwk, 3. tolerate actigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder for which CBT-I is not recommended (e.g., apnea), 6. scoring \\\u003C32 on Sleep Apnea scale, Sleep Disorders Ques.\n\nExclusion:\n\nCG Exclusion criteria: 1. unable to consent, 2. cognitive impairment \\[Telephone Interview for Cognitive Status (TICS) \\\u003C25\\], 3. sleep disorder other than insomnia \\[i.e., apnea (apnea\u002Fhypopnea index-AHI \\>15)\\], 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outside current trial.","ALL","18 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.",[78,79],"Insomnia","Dementia",[81],"Dementia Caregiver","2026-04-24",{"date":84,"type":85},"2026-04-30","ACTUAL",{"date":87,"type":85},"2022-02-02",{"date":89,"type":72},"2027-09-30",{"name":5,"class":6},1]