Mindfulness Based Stress Reduction for Adults With Migraines: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Migraine frequency from Baseline
研究概览
简要总结
This proposal describes a randomized controlled pilot trial investigating feasibility, safety, and migraine frequency in patients with migraines who undergo an 8 week mindfulness based stress reduction (MBSR) program compared to a wait-list control group.
详细描述
Preliminary research has shown MBSR to be effective in chronic pain syndromes and other mind/body interventions have shown good promise in the treatment of headaches. A randomized controlled trial (RCT) of yoga in migraine without aura patients by John and colleagues showed that yoga resulted in a significant decrease in headache frequency, pain index, and symptomatic medication usage compared to a self-care group. This RCT demonstrated that patients with headaches may benefit from a mind-body intervention. However, their yoga protocol was not specified, and participants were instructed to practice the technique only during the prodromal phase of a headache (prior to the pain becoming severe), so as an abortive intervention at the time of a headache. Thus, the investigators of this trial are proposing to evaluate the effect of MBSR on adults with migraines compared to an education control group. This study will add to the John study because, unlike many other mind-body interventions, MBSR offers the distinct advantage of a standardized protocol that has been used both clinically and in numerous research studies across a wide variety of conditions. Furthermore, MBSR teaches participants a daily practice that, if effective, could serve as a prophylactic intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Diagnosis of migraine (International Classification of Headache Disorders-II);21
- •4-14 days with migraines/month
- •≥one year of migraines
- •≥18 years
- •Able and willing to attend weekly sessions and willing to participate in daily mindfulness assignments, up to 30-45 min/day
- •Agreeable to participate and to be randomized to either group
- •Fluent in English (since the treatment groups will be run in English)
- •Good general health with no additional diseases expected to interfere with the study
排除标准
- •Current regular meditation/yoga practice
- •Any major systemic illness or unstable medical or psychiatric condition (e.g. suicide risk) requiring immediate treatment or that could lead to difficulty complying with the protocol
- •Diagnosis of medication overuse headache (International Classification of Headache Disorders-II);19
- •Current or planned pregnancy or breastfeeding
- •New prophylactic migraine medicine started within 4 weeks of the screening visit
- •Unwilling to maintain stable current doses of migraine medicines for the duration of trial
- •Failure to complete baseline diary recordings of migraine activity and medication use
结局指标
主要结局
Change in Migraine frequency from Baseline
时间窗: baseline, immediately post-intervention, 4 weeks post-intervention
Change in the number of migraines per month from baseline(tracked with headache logs)
次要结局
- Change in self-efficacy from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Change in perceived stress from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Change in migraine-related disability/impact from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Change in anxiety from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Change in depression from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Change in mindfulness from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Qualitative interviews(immediately post-intervention)
- Change in migraine severity from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Change in Migraine duration from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
- Change in quality of life from baseline(baseline, immediately post-intervention, 4 weeks post-intervention)
研究者
Rebecca Wells
Instructor
Brigham and Women's Hospital