Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study of the Intervention Program (ORBIT Phase IIa-IIb)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究者
David Ogez
Professor
Ciusss de L'Est de l'Île de Montréal