An interventional study of HYlaMI (Self-Hypnosis Training for Migraine Management) in Migraine Disorder, sponsored by Ciusss de L'Est de l'Île de Montréal. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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.
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).
Behavioral: HYlaMI (Self-Hypnosis Training for Migraine Management)
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.
Also known as: Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine
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.
Time frame: 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.
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)
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.
Time frame: Throughout intervention (first to 8th week of intervention: T1-T8)
Anxiety and depressive symptoms
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
Pain Self-Efficacy Questionnaire (PSEQ)
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)
Situational pain
Visual Analog Scale (VAS), 0-10
Time frame: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Situational anxiety
Visual Analog Scale (VAS), 0-10
Time frame: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)
Situational relaxation
Visual Analog Scale (VAS), 0-10
Time frame: 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)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12 )
Measure: Migraine intensity
Weekly migraine diary (average intensity, 0-10)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Migraine duration
Weekly migraine diary (duration in minutes)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Medication intake
Weekly migraine diary (type, dose, number of tablets)
Time frame: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)
Work/school absenteeism
Weekly migraine diary (number of absent days)
Time frame: 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)
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)
Economic burden of migraine
Cost in health questionnaire (direct and indirect costs)
Time frame: 6th week of intervention and 4-weeks-post-intervention follow-up (T6, T12)
Program improvement
Qualitative thematic analysis of two semi-structured focus groups
Time frame: T8 (end of intervention) and T12 (4-week follow-up)
Plan to share: Undecided
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Ciusss de L'Est de l'Île de Montréal