NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm
研究概览
简要总结
The investigators aim to determine the feasibility of a migraine self-management program.
详细描述
Patients with migraine seen by neurologists/headache specialists within or affiliated with the NYU Langone Health system will be identified via electronic medical record system, or in person. The investigators will randomize 50 participants to an in-person migraine self-management protocol, or a remote migraine self-management protocol. The investigators will examine benefits through follow-up at 2, 4, and 6 month time points.
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 (Investigator)
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
- •English speaking. (At this time, the validated app is only available in English.)
- •18-65 years of age
- •Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on a headache specialist or neurologist
- •Headaches for ≥1 year
- •Has not begun a new migraine preventative medication in the last month
- •Agreement to not make any preventive medication changes from the time of trial start until 3 months after beginning the study (Note - Acute medications may be changed if needed. Changes in preventive and acute medication and the time initiated will be recorded to evaluate the potential for medication confounds)
- •4-29 headache days a month (so the study includes those in whom the investigators typically offer preventive treatment [>4 headache days/month] and those with more frequent migraines including chronic migraine [15 days or more/month] but exclude those with continuous headaches)
排除标准
- •Diagnosis of Medication Overuse Headache (MOH)
- •Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy for migraine in the past year
- •Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
- •Current opioid or barbiturate use
- •PHQ-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the PHQ-9 (in this group, more intense psychological intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to develop medication overuse headache)
- •Unable or unwilling to follow a treatment program that relies on written and audio-taped materials
- •Coronary heart disease, heart attack, stroke, diabetes mellitus Type 1 or II
- •Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
- •Other physical limitations which would prevent participating in the standard protocol of biofeedback being studied
研究组 & 干预措施
In-Person Migraine Self-Management
干预措施: RELAXaHEAD Smartphone App (Behavioral)
In-Person Migraine Self-Management
干预措施: In-Person Training (Behavioral)
Remote Migraine Self-Management
干预措施: RELAXaHEAD Smartphone App (Behavioral)
Remote Migraine Self-Management
干预措施: Virtual Training (Behavioral)
结局指标
主要结局
Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm
时间窗: Up to Month 2
Satisfaction Scores
时间窗: Month 2
Assessment of satisfaction with the intervention using a Likert scale from 1 to 5 with 1 being strongly disagree, and 5 being strongly agree; the total score is the response; higher scores indicate greater satisfaction with the intervention.
Number of Days of At-Home Practice
时间窗: Up to Month 2
次要结局
未报告次要终点