[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448875":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":42,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":42,"enrollmentInfo":77,"targetDuration":42,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":46,"whyStopped":42,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Queen's University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pharmacotherapy","ACTIVE_COMPARATOR","Trazodone is the treatment of choice for insomnia and participants allocated to the pharmaceutical intervention group will be prescribed trazodone as a regular treatment for the duration of the study. Participants on trazodone will also visit the psychiatrist every month to ensure their wellbeing is protected, the quality of the data is maintained, the conduct of the trial is in compliance with the approved protocol, and other regulatory requirements. Trazodone is the routine practice for insomnia and is covered through most patients' healthcare. However, if the patient does not have coverage for trazodone, they will be provided financial compensation to offset the cost.",[13],"Drug: Trazodone",{"label":15,"type":16,"description":17,"interventionNames":18},"e-CBTi","EXPERIMENTAL","The e-CBTi modules will involve guiding participants to develop constructive and balanced strategies that would help to handle sleep problems. The e-CBTi program is based on the idea that insomnia is caused by thoughts and behaviours that can be changed. The modules aim to adjust negative thinking so patients can think about and adapt to the events that are happening to them, allowing them to adjust their behaviour and thoughts to be more realistic. Continuing, the modules are designed to help patients with insomnia deal with inaccurate thoughts about sleep and negative sleep behaviours, change their lifestyle practices that negatively affect their sleep, and improve relaxation skills to improve healthy sleep patterns. More specifically, the focus of the program is on addressing and exploring the concept of sleep, sleep habits, sleep hygiene, bedtime worries, negative thoughts, and thought examination.",[19],"Behavioral: e-CBTi",[21,27],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","See arm\u002Fgroup description",[15],[26],"Electronically-Delivered CBT",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Trazodone","See arm\u002Fgroup edescription",[9],[33],"Control",[35],{"name":36,"affiliation":5,"role":37},"Nazanin Alavi, MD FRCPC","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","6135443310",null,"nazanin.alavi@queensu.ca",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Kingston","Ontario","K7L5G2","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-76.48098,44.22976,{"lat":56,"lon":55},[59,60],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":36,"role":40,"phone":42,"phoneExt":42,"email":42},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Dr. Nazanin Alavi","Psychiatrist",[66],{"name":67,"class":6},"Online PsychoTherapy Clinic","100448875","investigating-the-effectiveness-of-e-cbti-compared-to-pharmaceutical-interventions-in-treating-insomnia-100448875",false,"NCT05125146","Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia","Investigating the Effectiveness of Electronically Delivered Cognitive Behavioural Therapy (e-CBTi) Compared to Pharmaceutical Interventions in the Treatment of Insomnia","Inclusion Criteria:\n\n* At least 18 years of age at the start of the study\n* Non-organic insomnia\n* Difficulty initiating, and\u002For maintaining sleep for ≥ 30 minutes and\n* Use of sleep-promoting medication at least three nights per week for at least 3 months\n* Ability to speak and read English\n* Consistent and reliable access to the internet.\n\nExclusion Criteria:\n\n* Presence of another untreated sleep disorder\n* Alcohol or substance use disorder\n* Ongoing CBT\n* Non-assessed or untreated clinically significant somatic or mental symptoms or illnesses\n* Other sleep disorders that could explain current insomnia symptoms or interfere with or be worsened by e-CBTi\n* Pregnancy","ALL","18 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","Insomnia is defined as the inability to fall asleep or stay asleep at night and it is one of the most prevalent sleep disorders that can have deleterious impacts on health and this population's quality of life. Currently, both pharmaceutical interventions (trazodone) and cognitive behavioral therapy (CBTi) are widely used to treat patients with insomnia. Although CBTi has been efficacious in many patients, multitude of barriers for receiving treatment such as its limited availability of therapists, high costs and long wait times challenge its ability in sufficiently meeting the population's health needs and demands. To improve the delivery of CBT, electronically delivered CBTi (e-CBTi) has been developed as an accessible and effective alternative intervention for improving sleep outcomes in patients with insomnia. While evidence suggest that e-CBTi is effective when compared to placebos\u002Fwaitlist control, evidence comparing guided e-CBTi to pharmaceutical interventions is still insufficient and needs further exploration.",[85],"Insomnia",[85,87,88,89,90,91,92,9,93],"Mental health","Psychotherapy","Cognitive behavioral therapy","Online","Internet","Mental health care","Pharmaceutical","2024-10-16",{"date":96,"type":97},"2024-10-18","ACTUAL",{"date":99,"type":97},"2021-11-01",{"date":101,"type":79},"2025-12-30",{"name":63,"class":6},1]