[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624141":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":45,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":80,"whyStopped":45,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":45},{"fullName":5,"class":6},"Woolcock Institute of Medical Research","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment: SleepFix + e-psychologist support calls","EXPERIMENTAL","Participants receive the SleepFix mobile application with weekly support calls from an e-psychologist for 3 weeks, with an optional additional 3 weeks of use. SleepFix will deliver digital brief behavioural therapy for insomnia (dBBTi) based on sleep consolidation therapy. The program aims to improve sleep efficiency by tailoring a personalised sleep window and gradually adjusting it. Participants will be instructed to use SleepFix for a 3-week period, with the option to continue for up to an additional 3 weeks. Weekly 15-20 minute sleep support calls from a trained e-psychologist will provide guidance, troubleshooting, and encouragement throughout the intervention period. Participants will also receive access to educational videos on sleep retraining.",[13],"Behavioral: SleepFix + e-psychologist support calls",{"label":15,"type":16,"description":17,"interventionNames":18},"Sleep Health Education (Active Control)","ACTIVE_COMPARATOR","Participants randomised to this arm will receive three online sleep health education modules delivered via email every two weeks over a 6-week period. The modules provide information on sleep and healthy sleep habits. Control group participants will be offered full access to the SleepFix application with the weekly support calls from an e-psychologist after completing their final follow-up assessment at week 14.",[19],"Behavioral: Sleep Health Education (Active control)",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","SleepFix + e-psychologist support calls","SleepFix mobile application uses Sleep Retraining Therapy (SRT) which aims to reduce excess time spent in bed awake and reset sleep by matching time in bed to total sleep time (TST). There are four stages to the SleepFix app and participants will progress based on completion of each stage. Participants are required to enter sleep and bedtime\u002Fwake data into the smartphone app for baseline referencing and determination of sleep therapy. SleepFix uses an algorithm that calculates optimal sleep efficiency based on participants data",[9],[27,28,29],"sleep restriction therapy","sleep consolidation therapy","sleep retraining therapy",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Sleep Health Education (Active control)","Three online sleep health education modules are provided to participants. It included information about healthy sleep, insomnia, sleep hygiene practices and information on general strategies for managing sleep for insomnia.",[15],[35],"sleep education",[37],{"name":38,"affiliation":5,"role":39},"Professor Delwyn Bartlett","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Yael Galgut, PhD Candidate","CONTACT","+61431333923",null,"yael.galgut@woolcock.org.au",{"name":48,"role":43,"phone":45,"phoneExt":45,"email":49},"Prof Delwyn Bartlett","delwyn.bartlett@woolcock.org.au",{"type":51,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[53],{"name":54,"class":6},"Macquarie University, Australia","100624141","sleepfix-for-youth-digital-behavioural-therapy-for-insomnia-with-e-psychologist-support-100624141",false,"NCT07405775","SleepFix for Youth: Digital Behavioural Therapy for Insomnia With E-Psychologist Support","iSLEEPY","Inclusion Criteria:\n\n* 16 -24 years old\n* Able to give informed online consent and if younger \\\u003C18years old guardian\u002Fparental consent\n* Insomnia Severity Index ≥ 10\n* English fluency\n* Access to a smartphone and willingness to use a mobile app for healthcare\n\nExclusion Criteria:\n\n* Shift-workers with regular shifts between the hours of 8pm and 8am.\n* Recent travel to a destination with \\>2 hours time difference (within last 7-days and with subjective reports that they are not experiencing jet lag).\n* Serious medical and\u002For psychiatric illnesses\u002Fdisorders (e.g., Epilepsy or other seizure disorders, heart failure, bipolar disorder, schizophrenia, Major Depressive disorder)\n* Self-reported\u002Fdiagnosed sleep disorders other than insomnia (e.g. - Obstructive Sleep Apnoea, REM\u002FNREM sleep disorders, Restless Leg Syndrome, Narcolepsy, free running cycle \\& Circadian rhythm disorder)\n* Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).\n* Pregnant\n* Professional driver or operate heavy machinery","ALL","16 Years","24 Years",{"count":66,"type":67},40,"ESTIMATED","INTERVENTIONAL",[70],"NA","This pilot randomised, open-label, parallel-group controlled trial will evaluate the feasibility, acceptability and effects of a psychologist-supported digital behavioural therapy for insomnia (dBTi) compared to a wait-listed active control (digital sleep health education) in young people aged 16-24 years with insomnia symptoms.\n\nThe primary objectives are to evaluate the feasibility of conducting a full-scale trial by assessing recruitment, consent and randomisation rates, intervention uptake, and data completeness. Secondary objectives include exploring treatment effects on insomnia severity (Insomnia Severity Index), sleep diary metrics, sleep quality, fatigue, and mood (depression and anxiety symptoms). Post-intervention interviews will assess participant experience and acceptability.\n\nResults will inform the design of a larger randomised controlled trial.",[73],"Insomnia",[75,76,77,78,79,27],"young people","adolescents","insomnia","CBTi","digital behavioural therapy for insomnia","NOT_YET_RECRUITING","2026-02-04",{"date":83,"type":84},"2026-02-12","ACTUAL",{"date":86,"type":67},"2026-02-01",{"date":88,"type":67},"2026-12-01",{"name":5,"class":6}]