[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599846":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers","EXPERIMENTAL",null,[13],"Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I",{"label":15,"type":16,"description":11,"interventionNames":17},"Sleep hygiene education","ACTIVE_COMPARATOR",[18],"Behavioral: Sleep hygiene education",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BEHAVIORAL","Nurse-Supported Mobile App for Self-Help CBT-I","The intervention consists of two components: 1) a mobile app (i.e., WeChat mini program) delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session (up to 20 minutes each) across a 6 week intervention period.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"The participants in the control group will receive only sleep hygiene (one-page handout) via WeChat. Access to the CBT-I WeChat mini program will be offered to these participants after the completion of the 3-month follow-up assessment.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Yangxi Huang","CONTACT","+85263581459","hyangxi@connect.hku.hk",[35],{"facility":36,"status":37,"city":38,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Shanghai University Shanghai Cancer Centre","RECRUITING","Shanghai","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":50,"phoneExt":11,"email":33},"Yangxi Huang, Master","+86 1570 8991 853",{"type":52,"investigatorFullName":30,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100599846","nurse-supported-mobile-app-for-self-help-cbt-i-in-informal-cancer-caregivers-100599846",false,"NCT07089797","Nurse-supported Mobile App for Self-help CBT-I in Informal Cancer Caregivers","Effect of Nurse-supported Mobile App for Self-help Cognitive Behavioral Therapy for Insomnia in Informal Cancer Caregivers: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years\n* Informal caregiver (e.g., family member or a friend) who co-resides with a cancer survivor of any site or stage and provides at least 4 hours of unpaid daily care. If two or more caregivers are available for a cancer survivor, the one providing most of the daily care will be included.\n* Able to understand the research procedures, and read and communicate in Chinese\n* Able to use WeChat\n* Insomnia severity index scores \\> 7\n\nExclusion Criteria:\n\n* Another sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome, rapid eye movement behavior disorder), besides insomnia, that is not adequately treated\n* Psychotic disorders (e.g., bipolar disorder, schizophrenia); Suicidal ideation with intent and plan OR attempted suicide within the past 2 months\n* Currently taking any psychotropic drugs (e.g., antidepressants, anxiolytics, sleep medications)\n* Unstable or acute medical condition or condition requiring surgery in the next 6 months; Pregnancy; or Epilepsy\n* Currently participating in any other interventional program\n* Prior experience with CBT-I\n* Night, evening, early morning or rotating shift work\n* Currently caring for a cancer patient receiving hospice care","ALL","18 Years",{"count":64,"type":65},208,"ESTIMATED","INTERVENTIONAL",[68],"NA","This mixed-methods randomized controlled trial investigates whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) effectively reduces insomnia severity among informal cancer caregivers, compared to sleep hygiene education.\\\u003Cbr\\>\\\u003Cbr\\>\n\nThe primary research question is:\\\u003Cbr\\> Does nurse-supported mobile app for self-help CBT-I lower insomnia severity among cancer caregivers compared to sleep hygiene education at post-intervention and 3-month follow-up?\\\u003Cbr\\>\\\u003Cbr\\>\n\nA total of 208 participants will:\\\u003Cbr\\>\n\n1. Be randomly assigned to one of two groups:\\\u003Cbr\\> (i) the nurse-supported mobile app-based self-help CBT-I group, which involves a 6-week CBT-I program delivered via a WeChat mini program along with weekly nurse support sessions (up to 20 minutes each); or\\\u003Cbr\\> (ii) the sleep hygiene education group.\\\u003Cbr\\>\n2. Complete assessments at baseline, post-intervention, and 3-month follow-up to measure changes in insomnia severity (primary outcome). Secondary outcomes include subjective sleep outcomes, psychological well-being, caregiver burden, fatigue, health-related quality of life, and participants' acceptability and satisfaction.\\\u003Cbr\\>\\\u003Cbr\\>\n\nAs recommended for trials of complex interventions, investigators will conduct a process evaluation in alignment with the Medical Research Council (MRC) guidance. The key functions of the process evaluation include: \\*(1) implementation, (2) mechanisms of impact, and (3) context.\\*",[71,72],"Insomnia Chronic","Cancer Caregivers","2026-02-13",{"date":75,"type":76},"2026-02-18","ACTUAL",{"date":78,"type":76},"2025-08-11",{"date":80,"type":65},"2026-08-01",{"name":5,"class":6},1]