BE WELL With Migraine: Brain Education and WELLness With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 4
- 主要终点
- Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.
详细描述
This study involves 8 weekly virtual sessions & an online platform designed to improve the lives of patients with migraine. Participants from across the United States with migraine may be eligible to participate. This study does not require any in-person visits. All assessments and surveys will be completed virtually and/or online. Participants will independently complete an initial online screen. Participants will attend a scheduled phone or videoconferencing call with a study team member to complete the baseline assessment and learn how to use the online platform. Participants will keep an online daily headache log and complete several online surveys throughout the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments, will be blinded.
In addition, blinded reports will be provided to the Wake Forest Data and Safety Monitoring Board (DSMB) for safety monitoring.
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
- •Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month
- •At least 1 year of migraine
- •At least 18 years old
- •Able to participate in 8 weekly online classes
- •Willingness to complete baseline headache logs
- •Headache-related disability (Headache Impact Test (HIT)-6) score >50
- •Fluent in English
- •Completion of technology onboarding with the online platform
- •Pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate
排除标准
- •Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
- •Medication overuse headache, with migraine treatment
- •Pregnant women who are more than 16 weeks gestation at enrollment
- •Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks OR acute treatment within 4 weeks to ensure stability
- •Unwillingness to maintain stable current medication dosages for study duration
- •Failure to complete baseline headache logs
- •Heavy alcohol and illicit drug use
- •Participation in another intervention clinical trial or one that would interfere in this study
- •Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR)
- •Any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study participant: COVID-positive test within 30 days of enrollment
研究组 & 干预措施
Brain Education and WELLness with Migraine Group A
8 weekly virtual sessions plus online platform
干预措施: Brain Education and WELLness with Migraine Group A (Behavioral)
Brain Education and WELLness with Migraine Group B
8 weekly virtual sessions plus online platform
干预措施: Brain Education and WELLness with Migraine Group B (Behavioral)
结局指标
主要结局
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
时间窗: Immediately post-intervention at 8 weeks
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
次要结局
- Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks(Immediately post-intervention at 8 weeks)
- Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks(Immediately post-intervention at 8 weeks)
- Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks(Immediately post-intervention at 8 weeks)
- Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks(Immediately post-intervention at 8 weeks)
- Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks(Immediately post-intervention at 8 weeks)
- Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks(Post-intervention at 20 weeks)
- Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks(Post-intervention at 32 weeks)
- Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks(Immediately post-intervention at 8 weeks)