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Migraine DisorderHYlaMINCT07644299

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

A study testing HYlaMI (Self-Hypnosis Training for Migraine Management) in people with Migraine Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine Disorder
What is being tested?
HYlaMI (Self-Hypnosis Training for Migraine Management)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
1 Jun 2026to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eloise Cardinal, PhD Student contact

514 895-7976

Eloise.cardinal@umontreal.ca

Canada1 site
  • Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR)

    Montreal, Quebec, H1T 2M4

    David Ogez, PhD, 514 252-3400 ext. 4443, david.ogez@umontreal.ca

Other trials in Canada

About this study

Official title: Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study of the Intervention Program (ORBIT Phase IIa-IIb)

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).

Read more

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).

Read the detailed description

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):

  • Session 1: Psychoeducation on medical hypnosis and pain + "Pleasant place" exercise
  • Session 2: "Backpack" exercise (anxiety and emotion management)
  • Session 3: "Doing nothing" exercise (pain acceptance, catastrophizing)
  • Session 4: "Thermal object" exercise (pain perception modification)
  • Session 5: "Magic hand" exercise (analgesic suggestion)
  • Session 6: "Rossi method" (resource-based pain relief)
  • Session 7: "Reconnecting with a resource" (introspection and self-efficacy)
  • Session 8: Conclusion, self-hypnosis prescription and 30 minutes Focus group on Social Validity of the intervention

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.

Being tested
HYlaMI (Self-Hypnosis Training for Migraine Management)
Keywords
migraine, self-hypnosis, clinical hypnosis, chronic pain, non-pharmacological intervention, telehealth, pain self-efficacy, pilot study, proof of concept, group intervention
Medical subject headings
Migraine Disorders, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HYlaMI (Self-Hypnosis Training for Migraine Management)Behavioural

    Also called Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine

    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.

Study groups in NCT07644299
Study groupRoleWhat they receive
Waitlist control groupNo interventionParticipants 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 GroupExperimentalParticipants 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).
Receives: Behavioral: HYlaMI (Self-Hypnosis Training for Migraine Management)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One-week-pre-intervention (T0) and 4-week post-intervention follow-up (4-weeks-post-intervention: T12)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: Throughout intervention (first to 8th week of intervention: T1-T8)

Secondary outcomes (13)
  1. Anxiety and depressive symptoms

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 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)

  2. Pain self-efficacy

    Pain Self-Efficacy Questionnaire (PSEQ)

    Measured: 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)

  3. Situational pain

    Visual Analog Scale (VAS), 0-10

    Measured: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)

  4. Situational anxiety

    Visual Analog Scale (VAS), 0-10

    Measured: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)

  5. Situational relaxation

    Visual Analog Scale (VAS), 0-10

    Measured: Before and after each hypnosis session (First to 7th week of intervention: T1-T7)

  6. Migraine frequency

    Weekly migraine diary (number of migraine days per week)

    Measured: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12 )

  7. Measure: Migraine intensity

    Weekly migraine diary (average intensity, 0-10)

    Measured: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)

  8. Migraine duration

    Weekly migraine diary (duration in minutes)

    Measured: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)

  9. Medication intake

    Weekly migraine diary (type, dose, number of tablets)

    Measured: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)

  10. Work/school absenteeism

    Weekly migraine diary (number of absent days)

    Measured: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)

  11. Quality of life economics

    EQ-5D (5 dimensions + VAS, score 0-1 and 0-100)

    Measured: 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)

  12. Economic burden of migraine

    Cost in health questionnaire (direct and indirect costs)

    Measured: 6th week of intervention and 4-weeks-post-intervention follow-up (T6, T12)

  13. Program improvement

    Qualitative thematic analysis of two semi-structured focus groups

    Measured: T8 (end of intervention) and T12 (4-week follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07644299
Sponsor's protocol ID
CEMTL 2026 4353
Acronym
HYlaMI
Status last verified
Jun 2026
First submitted
12 May 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing HYlaMI (Self-Hypnosis Training for Migraine Management) in people with Migraine Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Ogez, PhD (+1 514 252-3400 ext. 4443, david.ogez@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Migraine-related disability - Migraine Disability Assessment (MIDAS) (time frame: One-week-pre-intervention (T0) and 4-week post-intervention follow-up (4-weeks-post-intervention: T12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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