Study Protocol for a Randomized Controlled Trial of Neurofeedback Mindfulness in Chronic Migraines
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Migraine Disability
研究概览
简要总结
As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of 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
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •have a diagnosis of chronic migraine from a clinician or have met the criteria for a chronic migraine diagnosis based on ICHD-3
- •reside in Saskatoon area
- •have a smartphone and internet connection for accessing the MUSE app
- •have no frequent background experience of meditation
排除标准
- •Comorbidity of Raynaud's syndrome or diabetes
- •Current use of a preventative migraine treatment over 6 months
结局指标
主要结局
Migraine Disability
时间窗: 8 weeks
measured by Migraine Disability Assessment Scale (MIDAS)
Headache management self-efficacy
时间窗: 8 weeks
measured by Headache Management Self-Efficacy Scale
Dependence on medicine
时间窗: 8 weeks
measured by Severity of Dependence Scale (SDS)
Migraine Severity
时间窗: 8 weeks
measured by Headache Impact Test-short form (HIT-6)
次要结局
- Depression(8 weeks)
- Anxiety(8 weeks)
研究者
Marla Mickleborough
Dr. Marla Mickleborough
University of Saskatchewan