Mind Body Intervention for Chronic Migraine Headaches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- MIDAS
研究概览
简要总结
The goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. The main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. We will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Adult (≥ 18 years of age)
- •Previously diagnosed with migraine headache based on ICHD-3 beta criteria 91
- •A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact) 92
- •Presence of migraine headaches at least 5 days per month
- •Willing to engage in a Mind-Body intervention
- •Willing/able to participate in remote sessions
排除标准
- •Known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease)
- •Diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain)
- •Diagnosis of cognitive impairment or dementia
- •Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
- •Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.
研究组 & 干预措施
Mind-Body Intervention
A Novel Mind body technique for the intervention will be taught in lectures and group discussion sessions
干预措施: Mind-Body Intervention (Behavioral)
结局指标
主要结局
MIDAS
时间窗: baseline, 4, 8, 13 and 20 weeks
The 7-item Migraine Disability Assessment (MIDAS) is a commonly used and well validated self report survey for assessing migraine-related disability. Questions cover adverse life impacts (missed work, etc.), headache frequency, and headache intensity.
HIT-6
时间窗: baseline, 4, 8, 13 and 20 weeks
The Headache Impact Test (HIT-6), a well-validated self reported survey, measures the impact of headaches on 6 aspects of health-related quality of life. A recent study has estimated that a change of 6-7 points was clinically meaningful in a cohort starting with a mean HIT-6 score of 65.0 (severe impact). The HIT-6 is a recommended NIH common data element for headache.
次要结局
- Brief Pain Inventory Questionnaire (Short Form)(baseline, 4, 8, 13 and 20 weeks)
- Pain Anxiety Symptom Scale (Short Form 20)(baseline, 4, 8, 13 and 20 weeks)
- Somatic Symptoms Score (SSS-8)(baseline, 4, 8, 13 and 20 weeks)
- Migraine Duration(baseline, 4, 8, 13 and 20 weeks)
- NRS-11(baseline, 4, 8, 13 and 20 weeks)
- GAMS(baseline, 4, 8, 13 and 20 weeks)
- Feedback on protocol(13 weeks)
研究者
Michael Donnino
Principal Investigator
Beth Israel Deaconess Medical Center