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

NCT07644299 | Not Yet Recruiting DMC

• 1 other identifier: CEMTL 2026 4353
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Migraine Disorder

Keywords

migraine; self-hypnosis; clinical hypnosis; chronic pain; non-pharmacological intervention; telehealth; pain self-efficacy; pilot study; proof of concept; group intervention

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (13)

• Anxiety and depressive symptoms

  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

  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

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

• Situational anxiety

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

• Situational relaxation

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

Study Arms (2)

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).

Behavioral: HYlaMI (Self-Hypnosis Training for Migraine Management)

Interventions

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.

Also known as: Self-hypnosis training; autohypnosis; HYlaDO adaptation for migraine

HYlaMI Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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)

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

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

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Migraine Disorders; Chronic Pain

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

David Ogez, PhD

CONTACT

+1 514 252-3400; david.ogez@umontreal.ca

Eloise Cardinal, PhD Student

CONTACT

514 895-7976; Eloise.cardinal@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

CA (1)