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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).
Background.
Migraine affects approximately 1.04 billion individuals worldwide and is associated with substantial socioeconomic burdens, including reduced quality of life, mental health comorbidities (anxiety, depression), and productivity losses. Non-pharmacological interventions, including clinical hypnosis, represent a growing area of investigation.
Intervention.
The HYlaMI program consists of 8 weekly one-hour group sessions delivered via teleconference (Zoom, CIUSSS EMTL platform). Seven hypnotic exercises are introduced sequentially, each following a standard hypnotic structure (induction, deepening, hypnotic work, post-hypnotic suggestions, return to waking state):
A 9th session (1h-Focus group on Self-hypnosis practice+ follow-up meeting) is held 4 weeks post-intervention.
All 7 hypnotic exercises are provided as high-quality audio recordings to enable home self-hypnosis practice between sessions.
Study Design
Mixed-methods pilot and proof-of-concept study with two parallel arms: HYlaMI intervention group and waitlist control group. Randomization is performed using an online random group generator. For ethical reasons, waitlist participants will receive the full intervention after study completion.
Outcome Assessment Schedule
14 measurement time points are planned: T-1 and T0 (pre-intervention baseline), T1-T8 (weekly during intervention), and T9-T12 (weekly post-intervention follow-up).
Hypnotizability
Baseline hypnotizability is assessed using the Harvard Group Scale of Hypnotic Susceptibility, Form A (HGSHS:A), French online version, and will be used as a covariate in all analyses.
Data Management
Electronic questionnaires are managed via REDCap (CIUSSS EMTL server). Paper journals are used for in-session measures. Focus groups are recorded via Zoom, transcribed using OneDrive Word, and analyzed with NVivo 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYlaMI (Self-Hypnosis Training for Migraine Management) | Behavioral | Eight 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One-week-pre-intervention (T0) and 4-week post-intervention follow-up (4-weeks-post-intervention: T12) |
| 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. | One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12) |
| 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. | Throughout intervention (first to 8th week of intervention: T1-T8) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and depressive symptoms | Hospital Anxiety and Depression Scale (HADS) | One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12) |
| Pain self-efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Ogez, PhD | Contact | +1 514 252-3400 | 4443 | david.ogez@umontreal.ca |
| Eloise Cardinal, PhD Student | Contact | 514 895-7976 | Eloise.cardinal@umontreal.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) | Montreal | Quebec | H1T 2M4 | Canada |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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Pain Self-Efficacy Questionnaire (PSEQ)
| One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12) |
| Situational pain | Visual Analog Scale (VAS), 0-10 | Before and after each hypnosis session (First to 7th week of intervention : T1-T7) |
| Situational anxiety | Visual Analog Scale (VAS), 0-10 | Before and after each hypnosis session (First to 7th week of intervention : T1-T7) |
| Situational relaxation | Visual Analog Scale (VAS), 0-10 | Before and after each hypnosis session (First to 7th week of intervention: T1-T7) |
| Migraine frequency | Weekly migraine diary (number of migraine days per week) | Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12 ) |
| Measure: Migraine intensity | Weekly migraine diary (average intensity, 0-10) | Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12) |
| Migraine duration | Weekly migraine diary (duration in minutes) | Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12) |
| Medication intake | Weekly migraine diary (type, dose, number of tablets) | Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12) |
| Work/school absenteeism | Weekly migraine diary (number of absent days) | Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12) |
| Quality of life economics | EQ-5D (5 dimensions + VAS, score 0-1 and 0-100) | One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12) |
| Economic burden of migraine | Cost in health questionnaire (direct and indirect costs) | 6th week of intervention and 4-weeks-post-intervention follow-up (T6, T12) |
| Program improvement | Qualitative thematic analysis of two semi-structured focus groups | T8 (end of intervention) and T12 (4-week follow-up) |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |