Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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)

Where this trial is running

• Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR), Montreal, Quebec, Canada

Who to contact

David Ogez, PhD · +1 514 252-3400 · david.ogez@umontreal.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07644299.