[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547383":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":71,"collaborators":75,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":9,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":18,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":111,"whyStopped":18,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Basel","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SLEEPAC","EXPERIMENTAL","In addition to treatment-as-usual (TAU), participants of the SLEEPAC arm will receive a multi-component sleep intervention combining elements of CBT-i, circadian adaptation, and physical activity counselling.",[13],"Behavioral: SLEEPAC",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Participants of the control group continue with their treatment as usual",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","6x individual blended-care counselling sessions:\n\n* 1 x face-to-face kick-off sessions at study site (45 min)\n* 1 x try-out exercise sessions at study site (45 min)\n* 4 x online face-to-face sessions via zoom (30 min)\n* Both the intervention and the waitlist control condition will continue with TAU.\n\nComponent 1: CBT-I: Sleep restriction, and cognitive therapy strategies with education about sleep-wake regulation, sleep hygiene, and pre-bedtime counter arousal methods.\n\nComponent 2: Circadian treatment: Morning bright light therapy with a gradual advanced sleep schedule and timed morning exercise.\n\nComponent 3: Physical activity counselling involves providing personalized guidance and support to individuals to help them adopt and maintain a physically active lifestyle tailored to their preferences and needs.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Christin Lang, PhD","CONTACT","+41 61 207 61 45","christin.lang@unibas.ch",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Leila Tarokh, Prof","+41 31 932 86 19","leila.tarokh2@unibe.ch",[35,56],{"facility":36,"status":18,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Department of Sport, Exercise, and Health, University of Basel","Basel","Canton of Basel-City","4052","Switzerland","CH",{"type":43,"coordinates":44},"Point",[45,46],7.57327,47.55839,{"lat":46,"lon":45},[49,51,54],{"name":26,"role":27,"phone":50,"phoneExt":18,"email":29},"0041 61 207 61 45",{"name":52,"role":27,"phone":18,"phoneExt":18,"email":53},"Markus Gerber, Prof","markus.gerber@unibas.ch",{"name":26,"role":55,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"facility":57,"status":18,"city":58,"state":59,"zip":60,"country":40,"countryCode":41,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University Hospital of Child and Adolescent Psychiatry and Psychotherapy","Bern","Canton of Bern","3000",{"type":43,"coordinates":62},[63,64],7.44744,46.94809,{"lat":64,"lon":63},[67,69,70],{"name":26,"role":27,"phone":68,"phoneExt":18,"email":29},"0041 79 109 22 74",{"name":31,"role":27,"phone":18,"phoneExt":18,"email":33},{"name":26,"role":55,"phone":18,"phoneExt":18,"email":18},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Christin Lang","PhD",[76,78,79,81],{"name":36,"class":77},"UNKNOWN",{"name":57,"class":77},{"name":80,"class":6},"University Children's Hospital Basel",{"name":82,"class":77},"Psychiatry Baselland","100547383","promoting-sleep-and-physical-activity-among-adolescent-psychiatric-patients-100547383",false,"NCT06407258","Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients","Transdiagnostic Sleep Intervention Combined With Physical Activity Counseling (SLEEPAC) in Adolescent Psychiatric Patients: A Blended Care Approach","Inclusion Criteria:\n\n* Aged between 13 to 18 years\n* Presence of insomnia and\u002For delayed sleep-wake phase disorder\n* At least one further diagnosis of DSM-5\n* Written informed consent of parents \u002F primary caregiver\n\nExclusion Criteria:\n\n* Organic sleep- and brain disorders (i.e., obstructive sleep apnea, narcolepsy, epilepsy)\n* Suffering from medical conditions, which prevent participation in physical activity\n* Changes to medication regime during the study protocol\n* Color-blindness (due to stroop test)","ALL","13 Years","18 Years",{"count":94,"type":95},140,"ESTIMATED","INTERVENTIONAL",[98],"NA","Mental health disorders pose a significant burden on adolescent populations globally, often accompanied by sleep disturbances. Emerging evidence suggests that addressing sleep issues can improve mental health outcomes, while physical activity is increasingly recognized as beneficial for both sleep and mental well-being. This study aims to assess the effectiveness of a novel intervention (SLEEPAC), combining cognitive-behavioral therapy for insomnia (CBT-I), circadian treatment, and PA counseling, compared to treatment as usual (TAU), in improving psychopathology among adolescent psychiatric outpatients with sleep disturbances. Secondary outcomes include improvements in sleep health, physical activity levels, cognitive performance and self-esteem. Additionally, the study seeks to explore the predictive value of sleep neurophysiological biomarkers using high-density sleep electroencephalography (EEG), contributing to advancements in precision psychiatry for this population.",[101,102,103],"Mental Disorder in Adolescence","Insomnia","Delayed Sleep-Wake Phase Disorder",[105,106,107,108,109,110],"adolescents","CBT-I","light therapy","circadian adaptation","physical activity counseling","transdiagnostic","NOT_YET_RECRUITING","2024-05-06",{"date":114,"type":115},"2024-05-09","ACTUAL",{"date":117,"type":95},"2024-06-01",{"date":119,"type":95},"2026-06-30",{"name":73,"class":6},2]