Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Headache-Related Disability Index
研究概览
简要总结
This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICHD-3 beta headache diagnosis of migraine,
- •self-reported and diary-confirmed 4-20 headache days per month
- •aged 18-65
- •ability to read English
- •capacity to consent.
排除标准
- •no ICHD-3 beta headache diagnosis of migraine
- •fewer than 4 or greater than 20 headache days per month
- •under 18 or over 65
- •inability to read English
- •lacking the capacity to consent
- •utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study
- •severe psychiatric illness that would interfere with participation in the treatment
研究组 & 干预措施
MBCT for Migraine
In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day & Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.
干预措施: MBCT for Migraine (Behavioral)
Wait List/Treatment as Usual
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
结局指标
主要结局
Headache-Related Disability Index
时间窗: Change from Month 1 to Month 4
25-item, self-report questionnaire of the emotional and functional impact of headache on daily activities. Total scores range from 0-100, with higher scores indicating higher levels of disability.
Proportion of People With "Severe" Scores on the Migraine Disability Assessment
时间窗: Change from Month 1 to Month 4
The MIDAS is a 5-item, self-report instrument that assesses the number of days in the past three months participants experienced partially or fully reduced functioning in a variety of contexts (work, school, social). MIDAS scores are totaled and interpreted in the following grades: 0-5 = Grade I (Little or no disability); 6-10 = Grade II (Mild disability); 11-20 = Grade III (Moderate disability); 21+ = Grade IV (Severe disability). Scores were dichotomized at "Not Severe" (Grades I, II, and III) and "Severe "(Grade IV). The outcome was the proportion of participants who reported "Severe Disability."
次要结局
- Average Headache Severity for Headache Days Recorded Over 30 Days(Change from Month 1 to Month 4)
- The Pain Catastrophizing Scale(Change from Month 1 to Month 4)
- Five Facet Mindfulness Questionnaire(Change from Month 1 to Month 4)
- Headache Management Self-efficacy Scale(Change from Month 1 to Month 4)
- NIH PROMIS Depression Short Form(Change from Month 1 to Month 4)
- Headache Days (Over Course of 1 Month)(Change from Month 1 to Month 4)
- Chronic Pain Acceptance Questionnaire(Change from Month 1 to Month 4)
- Headache Specific Locus of Control(Change from Month 1 to Month 4)
- Average Monthly Migraine Disability Index(Change from Month 1 through Month 4)
- NIH PROMIS Anxiety Short Form(Change from Month 1 to Month 4)
研究者
Elizabeth Seng
Assistant Professor
Albert Einstein College of Medicine