Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study
Not yet recruitingNot applicableNCT07644299
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Brief summary (from the registry)
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. The 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/CIUSSS EMTL platform). This 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/anxiety/relaxation, migraine frequency, intensity and duration, medication intake, work absenteeism, quality of life, and the economic burden of migraine. A 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 imp…
Study details
- Official title
- Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study of the Intervention Program (ORBIT Phase IIa-IIb)
- Conditions
- Migraine Disorder
- Interventions
- Behavioral: HYlaMI (Self-Hypnosis Training for Migraine Management)
- Sponsor
- Ciusss de L'Est de l'Île de Montréal
- Start date
- 2026-06-01
- Primary completion
- 2027-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Formal diagnosis of migraine for more than one year (physician-issued; self-reported diagnosis accepted) * French-speaking * 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) * Reliable internet connection * Available to follow the 2.5-month self-hypnosis training program Exclusion Criteria: * Sensory or cognitive impairments that would interfere with comprehension (e.g., deafness) * Severe, unstabilized neurological or psychiatric disorder that impairs communication * Previous psychological treatment using hypnosis techniques for pain management * Current participation in another psychological intervention (potential confounder for anxiety/depression outcomes)
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07644299