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 improvement.
If successful, this study will provide the evidence base required to proceed to a larger randomized controlled trial (ORBIT Phase III).
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
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)
Parallel
HYlaMI (Self-Hypnosis Training for Migraine Management)
BehavioralEight weekly one-hour group telehealth sessions (Zoom/CIUSSS 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.
Migraine-related disability - Migraine Disability Assessment (MIDAS)
5-item scale quantifying the number of days affected by migraine in the past 3 months, generating a disability grade (I-IV). Clinically significant improvement defined as a reduction of ≥5 points (grade III, initial score 11-20) or ≥30% (grade IV, initial score \>20), per American Headache Society (2019) criteria.
Migraine-related disability - Headache Impact Test (HIT-6)
6-item scale (score range 36-78) assessing headache impact on daily functioning. Clinically significant improvement defined as a reduction of ≥5 points, per American Headache Society (2019) criteria.
Program feasibility - Retention and adherence rates
Descriptive analysis of session attendance (target: ≥6/8 sessions) and attrition rate (target: ≤15%), based on the HYlaDO pilot study.
Anxiety and depressive symptoms
Hospital Anxiety and Depression Scale (HADS)
Pain self-efficacy
Pain Self-Efficacy Questionnaire (PSEQ)
Situational pain
Visual Analog Scale (VAS), 0-10
Situational anxiety
Visual Analog Scale (VAS), 0-10
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