Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR)
Montreal, Quebec, H1T 2M4, Canada
NCT Number: NCT07644299
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H1T 2M4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine
Time frame: One-week-pre-intervention (T0) and 4-week post-intervention follow-up (4-weeks-post-intervention: T12)
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.
Time frame: 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)
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.
Time frame: Throughout intervention (first to 8th week of intervention: T1-T8)
Descriptive analysis of session attendance (target: ≥6/8 sessions) and attrition rate (target: ≤15%), based on the HYlaDO pilot study.
Time frame: 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)
Hospital Anxiety and Depression Scale (HADS)
Time frame: 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 Questionnaire (PSEQ)
Time frame: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Visual Analog Scale (VAS), 0-10
Time frame: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Visual Analog Scale (VAS), 0-10
Time frame: Before and after each hypnosis session (First to 7th week of intervention: T1-T7)
Visual Analog Scale (VAS), 0-10
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12 )
Weekly migraine diary (number of migraine days per week)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (average intensity, 0-10)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (duration in minutes)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (type, dose, number of tablets)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Weekly migraine diary (number of absent days)
Time frame: 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)
EQ-5D (5 dimensions + VAS, score 0-1 and 0-100)
Time frame: 6th week of intervention and 4-weeks-post-intervention follow-up (T6, T12)
Cost in health questionnaire (direct and indirect costs)
Time frame: T8 (end of intervention) and T12 (4-week follow-up)
Qualitative thematic analysis of two semi-structured focus groups
Contact information is provided by the study sponsor or research team.
Ciusss de L'Est de l'Île de Montréal
Other
Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study of the Intervention Program (ORBIT Phase IIa-IIb)
Acronym: HYlaMI
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