[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528095":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT-I","ACTIVE_COMPARATOR","A total of 6 sessions of face-to-face group CBT-I therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects.",[13],"Behavioral: CBT-I",{"label":15,"type":16,"description":17,"interventionNames":18},"CBT-I combined ACT","EXPERIMENTAL","A total of 6 sessions of face-to-face group CBT-I+ACT therapy will be provided. Each session will last 90-120 mins, with each group 8-10 subjects.",[19],"Behavioral: CBT-I combined ACT",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The CBT-I intervention will cover sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation training.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"In addition to the standard CBT-I components, mindfulness, thought diary, and other ACT components will be taught in the group.",[15],[30],{"name":31,"affiliation":32,"role":33},"Rachel Ngan Yin Chan, PhD","Department of Psychiatry, the Chinese University of Hong Kong","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","39710550","rachel.chan@cuhk.edu.hk",{"name":40,"role":36,"phone":37,"phoneExt":25,"email":41},"Julia Wai Han Sun, M.S.Sc","julia.sun@cuhk.edu.hk",[43],{"facility":32,"status":44,"city":45,"state":46,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Shatin","New Territories","Hong Kong","HK",{"type":50,"coordinates":51},"Point",[52,53],114.18333,22.38333,{"lat":53,"lon":52},[56],{"name":31,"role":36,"phone":57,"phoneExt":25,"email":38},"39710548",{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"CHAN NGAN YIN","Assistant Professor, Department of Psychiatry","100528095","cbt-i-versus-cbt-iact-for-youths-with-insomnia-and-anxiety-100528095",false,"NCT06156306","CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety","Effectiveness of CBT-I and CBT-I Combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial","Inclusion Criteria:\n\nYouth who meet the following criteria would be eligible for taking part in this trial:\n\ni. Chinese youth aged 15-24 years old, ii. Presence of insomnia problems as defined by insomnia severity index (ISI) using cut-off of 9, which has been locally validated cut off for detecting clinical insomnia), iii. Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 10 for detecting clinical anxiety, iv. Ability to listen, speak, and read Chinese and Cantonese, and v. Written informed consent of participation into the study is given by youth and his\u002Fher parent's if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi. Possession of smartphone\n\nExclusion Criteria:\n\nA youth would be excluded from the study if meeting one or more of the following criteria:\n\ni. A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability ii. Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP) iii. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID) iv. Currently receiving psychological treatment and\u002For pharmacological treatment for insomnia or anxiety disorder.","ALL","15 Years","24 Years",{"count":72,"type":73},50,"ESTIMATED","INTERVENTIONAL",[76],"NA","Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. CBT for insomnia (CBT-I) has been shown to be effective in improving sleep complaints and short-term improvement in mood while previous systematic reviews of interventional studies have demonstrated the effectiveness of acceptance and commitment therapy (ACT) interventions in treating insomnia, both as a primary condition and with other physical and\u002For mental health comorbidities. This study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth.",[79,80,81],"Insomnia","Anxiety","Youth",[79,80,81],"2025-07-08",{"date":85,"type":86},"2025-07-10","ACTUAL",{"date":88,"type":86},"2023-12-15",{"date":90,"type":73},"2025-12-31",{"name":5,"class":6},1]