NCT05003362已完成不适用
Acceptance and Commitment Therapy for High Frequency Episodic Migraine
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Feasibility of a randomized controlled trial of ACT
研究概览
简要总结
Mindfulness Training specifically for pain to be offered to migraine patients
详细描述
Patients with high frequency migraine will be randomized to UC or intervention. Those in intervention will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
randomized control
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 18-65
- •Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria)
- •4-14 migraine days per month over the past 3 months
- •No change in medication in the past 3 months
- •Greater than 1 year of migraines
- •Agreeable to participate, commit to all study procedures and to be randomized to either group
- •Fluent in English
排除标准
- •Any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol
- •Active suicidal ideation
- •Moderate to severe depression
- •Current alcohol or substance abuse
- •Recent Cognitive Behavioral Therapy, Mindfulness Based Cognitive Therapy, Dialectic Behavioral Therapy or Acceptance and Commitment Therapy within past 3 years
- •Current use of narcotics
- •Psychiatric hospitalization within past year
- •Comorbid pain condition rated as more painful than migraine
- •Starts new migraine treatment during study
- •Inability to complete study visits
研究组 & 干预措施
usual care
No Intervention
Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician.
ACT
Active Comparator
An 8-week mindfulness-based group therapy.
干预措施: ACT (Behavioral)
结局指标
主要结局
Feasibility of a randomized controlled trial of ACT
时间窗: one year
Demonstrate that 48 patients can be successfully enrolled and randomized
次要结局
- Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability(one year)
- Change in migraine severity, duration, and medication use.(one year)
- Change in headache-related disability(one year)
- Change in quality of life.(one year)
- Change in depression and anxiety.(one year)
- Change in pain acceptance and pain expectancy.(one year)
- Change in pain catastrophizing.(one year)
- Change in distress tolerance.(one year)
- Change in physical activity.(one year)
- Change in perceived stress.(one year)
- Change in mindfulness.(one year)
- Change in cortisol levels.(one year)
研究者
Carolyn A. Bernstein
Principal Investigator
Brigham and Women's Hospital
研究点 (1)
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