[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643180":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":32,"locations":38,"responsibleParty":49,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":24,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":77,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Sleep Hygiene Education","EXPERIMENTAL","Participants in this group will receive a structured six-week SHE intervention. The intervention includes two weekly 2-hour group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each. During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practices, and will develop individualized behavior change plans to support sustained implementation of sleep hygiene practices. The subsequent telephone consultations will reinforce adherence to these plans by reviewing progress, discussing barriers, and providing tailored feedback.",[13],"Behavioral: Sleep Hygiene Education",{"label":15,"type":16,"description":17,"interventionNames":18},"CBT-I App","ACTIVE_COMPARATOR","Participants in this group will receive a CBT-I program consisting of six weekly modules delivered in the Chinese language through a smartphone application proACT-S. The duration of each module is around 45 to 60 min with interactive features. The self-help CBT-I treatment content in proACT-S is based on the Chinese translated version of a well-established CBT-I treatment manual. The self-help CBT-I treatment content is designed to alter dysfunctional cognitive beliefs and maladaptive behaviors that perpetuate insomnia. The self-help CBT-I treatment content CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia.",[19],"Behavioral: CBT-I Apps",{"label":21,"type":22,"description":23,"interventionNames":24},"Waitlist Control","NO_INTERVENTION","Participants in this group will receive no intervention from the study. They will be provided with the same SHE program and CBT-I apps after the follow-up period. Waitlist control is chosen as previous surveys have revealed that almost half of individuals with clinical insomnia refrain from seeking any treatment. Therefore, the waitlist control group reflects the typical help-seeking behavior of those coping with insomnia, thus providing a more realistic comparison for our study.",null,[26,29],{"type":27,"name":9,"description":11,"armGroupLabels":28,"otherNames":24},"BEHAVIORAL",[9],{"type":27,"name":30,"description":17,"armGroupLabels":31,"otherNames":24},"CBT-I Apps",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Wing Fai YEUNG","CONTACT","852-27664151","jerry-wf.yeung@polyu.edu.hk",[39],{"facility":40,"status":24,"city":41,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":24},"School of Nursing, The Hong Kong Polytechnic University","Hong Kong","HK",{"type":44,"coordinates":45},"Point",[46,47],114.17469,22.27832,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","YEUNG Wing Fai","Associate Professor","100643180","a-theory-based-sleep-hygiene-education-for-insomnia-disorder-100643180",false,"NCT07642479","A Theory-based Sleep Hygiene Education for Insomnia Disorder","A Theory-based Sleep Hygiene Education for Insomnia Disorder - A Non-inferiority Randomized Controlled Trial With Mixed-method Process Evaluation and Cost-effectiveness Analysis","Inclusion Criteria:\n\n* Hong Kong residents\n* Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua\n* Who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire\n* Scored at least 10 points in the Insomnia Severity Index\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV\n* Other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)\u002Fperiodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS\u002FPLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment\n* Any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia\n* Taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders\n* Impaired cognitive functioning (\\\u003C22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions\n* Pregnant\n* Shift work","ALL","18 Years","65 Years",{"count":64,"type":65},264,"ESTIMATED","INTERVENTIONAL",[68],"NA","Insomnia is a prevalent sleep disorder associated with numerous adverse health outcomes, including fatigue, irritability, and impaired daytime functioning. Despite the availability of effective pharmacological and psychological treatments, relatively few individuals with insomnia seek professional help, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. Building on our previously registered pilot-testing protocol, this study aims to examine the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community population. Furthermore, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as cognitive behavioral therapy for insomnia (CBT-I) delivered via digital applications. Therefore, this study will also compare the effectiveness of theory-based SHE with a CBT-I app using a three-arm randomized controlled trial design.",[71,72],"Insomnia","Adults",[71,74,75,76,72],"Sleep hygiene education","A non-inferiority randomized controlled trial","CBT-I apps","NOT_YET_RECRUITING","2026-06-07",{"date":80,"type":81},"2026-06-11","ACTUAL",{"date":83,"type":65},"2026-07-10",{"date":85,"type":65},"2028-06-30",{"name":5,"class":6},1]