[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642094":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":27,"locations":38,"responsibleParty":55,"collaborators":12,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":12,"enrollmentInfo":69,"targetDuration":12,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":89,"whyStopped":12,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Ciusss de L'Est de l'Île de Montréal","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Waitlist control group","NO_INTERVENTION","Participants assigned to the waitlist control group do not receive the HYlaMI intervention during the study period. They complete the same electronic questionnaires and weekly migraine diaries as the intervention group. For ethical reasons, they will receive the full HYlaMI intervention after study completion.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"HYlaMI Intervention Group","EXPERIMENTAL","Participants assigned to the HYlaMI group attend 8 weekly group telehealth sessions and practice self-hypnosis at home using provided audio recordings. They complete paper journals (in-session EVA ratings and qualitative feedback), weekly electronic migraine diaries, weekly self-hypnosis practice logs, and all standardized questionnaires at designated time points. They participate in two semi-structured focus groups (T8 and T12).",[18],"Behavioral: HYlaMI (Self-Hypnosis Training for Migraine Management)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","HYlaMI (Self-Hypnosis Training for Migraine Management)","Eight weekly one-hour group telehealth sessions (Zoom\u002FCIUSSS EMTL platform) delivering 7 complementary self-hypnosis exercises targeting migraine-related pain, stress, anxiety, and psychological resources. Each session follows a standardized hypnotic structure. High-quality audio recordings of all exercises are provided to participants for home self-hypnosis practice. A clinician-researcher (doctoral candidate in neuropsychology, trained in hypnosis) leads all sessions using a standardized clinician manual. A concluding focus group and follow-up session is held 4 weeks post-intervention.",[14],[26],"Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"David Ogez, PhD","CONTACT","+1 514 252-3400","4443","david.ogez@umontreal.ca",{"name":35,"role":30,"phone":36,"phoneExt":12,"email":37},"Eloise Cardinal, PhD Student","514 895-7976","Eloise.cardinal@umontreal.ca",[39],{"facility":40,"status":12,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR)","Montreal","Quebec","H1T 2M4","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-73.58781,45.50884,{"lat":50,"lon":49},[53],{"name":29,"role":30,"phone":54,"phoneExt":32,"email":33},"514 252-3400",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","David Ogez","Professor","100642094","self-hypnosis-training-for-migraine-management-hylami-a-pilot-and-proof-of-concept-study-100642094",false,"NCT07644299","Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study","Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study of the Intervention Program (ORBIT Phase IIa-IIb)","HYlaMI","Inclusion Criteria:\n\n* Formal diagnosis of migraine for more than one year (physician-issued; self-reported diagnosis accepted)\n* French-speaking\n* No consumption of alcohol or recreational drugs on the morning before group hypnosis sessions (migraine rescue medication is accepted but must be reported if taken before a session)\n* Reliable internet connection\n* Available to follow the 2.5-month self-hypnosis training program\n\nExclusion Criteria:\n\n* Sensory or cognitive impairments that would interfere with comprehension (e.g., deafness)\n* Severe, unstabilized neurological or psychiatric disorder that impairs communication\n* Previous psychological treatment using hypnosis techniques for pain management\n* Current participation in another psychological intervention (potential confounder for anxiety\u002Fdepression outcomes)","ALL","18 Years",{"count":70,"type":71},40,"ESTIMATED","INTERVENTIONAL",[74],"NA","Migraine is one of the most common and disabling neurological conditions worldwide, affecting approximately 1 billion people. Available pharmacological treatments have significant limitations (side effects, contraindications, medication overuse), highlighting the need for effective non-pharmacological alternatives.\n\nThe HYlaMI program (Self-Hypnosis Training for Migraine Management) is an 8-session group-based telehealth intervention adapted from HYlaDO, a self-hypnosis program developed for chronic pain management at the Hôpital Maisonneuve-Rosemont Pain Clinic (Montréal, Canada). Building on a refinement study conducted in autumn 2025 (CER: 2026-4061), HYlaMI combines heterohypnosis (guided by a trained clinician) and self-hypnosis (practiced autonomously at home using audio recordings) through weekly one-hour video sessions (Zoom\u002FCIUSSS EMTL platform).\n\nThis study combines ORBIT Phase IIa (proof of concept) and Phase IIb (pilot study) objectives. The primary aims are to evaluate the feasibility of the HYlaMI program (retention and adherence rates) and to assess whether it can generate a clinically significant change in migraine-related disability compared to a waitlist control group. Secondary aims include evaluating effects on anxiety and depressive symptoms, pain self-efficacy, situational pain\u002Fanxiety\u002Frelaxation, migraine frequency, intensity and duration, medication intake, work absenteeism, quality of life, and the economic burden of migraine.\n\nA mixed-methods design will be used. Forty adults with a diagnosis of migraine for more than one year will be randomized to either the HYlaMI intervention group (n=20) or a waitlist control group (n=20). Participants will complete validated questionnaires at multiple time points (pre-intervention, mid-intervention, post-intervention, and 4-week follow-up), a weekly migraine diary, and self-hypnosis practice logs. Two semi-structured focus groups will be conducted with intervention group participants to inform program improvement.\n\nIf successful, this study will provide the evidence base required to proceed to a larger randomized controlled trial (ORBIT Phase III).",[77],"Migraine Disorder",[79,80,81,82,83,84,85,86,87,88],"migraine","self-hypnosis","clinical hypnosis","chronic pain","non-pharmacological intervention","telehealth","pain self-efficacy","pilot study","proof of concept","group intervention","NOT_YET_RECRUITING","2026-06-08",{"date":92,"type":93},"2026-06-12","ACTUAL",{"date":95,"type":71},"2026-06-01",{"date":97,"type":71},"2027-09-30",{"name":5,"class":6},1]