[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487795":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":69,"collaborators":72,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":25,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":25,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Douglas Mental Health University Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VR-CBT","EXPERIMENTAL","A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks.",[13],"Behavioral: VR-CBT",{"label":15,"type":16,"description":17,"interventionNames":18},"Self-management","ACTIVE_COMPARATOR","Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks.",[19],"Behavioral: Self-management",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The therapy is focused on emotion regulation through guided learning in virtual reality. The manual is a modified conventional cognitive behavioral therapy to include these aspects and the suggestions of an advisory committee of Inuit and non-Inuit health service providers (e.g., cultural adaptation).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The previously developed commercial VR program involves guided relaxation and meditation techniques.",[15],[30],{"name":31,"affiliation":5,"role":32},"Outi Linnaranta, MD, Ph.D","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Karyne Anselmo, M.Sc.","CONTACT","514-761-6131","3296","karyne.anselmo@douglas.mcgill.ca",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Montreal","Quebec","h4h 1r3","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-73.58781,45.50884,{"lat":52,"lon":51},[55,57,61,63,65,67],{"name":56,"role":36,"phone":37,"phoneExt":38,"email":39},"Karyne Anselmo, MSc",{"name":58,"role":36,"phone":37,"phoneExt":59,"email":60},"Quinta Seon, MSc","3009","quinta.seon@mail.mcgill.ca",{"name":62,"role":32,"phone":25,"phoneExt":25,"email":25},"Outi Linnaranta, MD, PhD",{"name":58,"role":64,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":66,"role":64,"phone":25,"phoneExt":25,"email":25},"Martin Lepage, PhD",{"name":68,"role":64,"phone":25,"phoneExt":25,"email":25},"Elisabeth Thibaudeau, PhD",{"type":32,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Martin Lepage","James McGill professor",[73,75,78,81],{"name":74,"class":6},"Natural Sciences and Engineering Research Council, Canada",{"name":76,"class":77},"MedTeq","INDUSTRY",{"name":79,"class":80},"Douglas Foundation","UNKNOWN",{"name":82,"class":6},"McGill University","100487795","vr-cbt-with-inuit-in-quebec-100487795",false,"NCT05631743","VR-CBT With Inuit in Quebec","A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial","Inclusion Criteria:\n\n1. Self-identify as Inuk\n2. Live in Montreal\n3. be between 14 to 60 years of age\n4. be proficient in English or French\n5. No history of cardiac conditions\n6. No history of epilepsy\n7. Can provide an emergency contact\n8. Tolerance of VR headset\n9. Tolerance of sensors\n10. Has no current suicidal or homicidal risk\n11. No history of psychosis or schizophrenia\n12. Current stable mood\n13. Is generally mentally stable\n14. Score less than 8 on the Alcohol Use Disorders Identification Test C\n15. Score less than 3 on the Drug Abuse Screen Test (10 item version)\n16. Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study\n\nExclusion Criteria:\n\n1. does not identify as Inuk\n2. youth below the age of 14 and adults above the age of 60.\n3. self-reported history of psychosis or schizophrenia\n4. current substance abuse, as measured by two screens (AUDIT-C, DAST-10)\n5. other mental or physical condition that might preclude them from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk).","ALL","14 Years","60 Years",{"count":94,"type":95},40,"ESTIMATED","INTERVENTIONAL",[98],"NA","The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment.",[101],"Emotion Regulation",[103,104],"virtual reality","cognitive behavioural therapy","2025-02-10",{"date":107,"type":108},"2025-02-12","ACTUAL",{"date":110,"type":108},"2023-07-15",{"date":112,"type":95},"2025-12-31",{"name":5,"class":6},1]