NCT05415020招募中不适用
Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Interested Participants that are Enrolled
研究概览
简要总结
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.
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
- 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
- •have chronic migraine for a minimum of 1-year
- •aged 18 years and older
排除标准
- •other headache disorders including secondary headache disorders
- •children younger than 18 years old
- •current pregnancy
研究组 & 干预措施
Attention Placebo Group
Sham Comparator
干预措施: Sham Behavior Protocol (Behavioral)
Virtual Therapy Group
Active Comparator
干预措施: Lifestyle Behavior Protocol (Behavioral)
结局指标
主要结局
Number of Interested Participants that are Enrolled
时间窗: 12 weeks
Recruitment rate (Feasibility Outcome)
Acceptability
时间窗: 12 weeks
Retention rate
次要结局
- Mean change from baseline monthly migraine frequency(12 weeks)
- Migraine severity(12 weeks)
研究者
Yohannes Woubishet Woldeamanuel
Principal Investigator
Mayo Clinic
研究点 (2)
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