RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Daily Diary Satisfaction Scores
研究概览
简要总结
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years (age 18-65 in urgent care);
- •Meets migraine criteria based on the International Classification of Headache Disorders (ICHD) criteria;
- •Migraine Disability Assessment (MIDAS) score >
- •4+ headache days a month OR; meets chronic post- traumatic headache (PTH) criteria based on International Classification of Headache Disorders (ICHD) criteria, is 3-12 months post-injury, and there are 4+ headache days a month.
- •Scoring > or = 15 on the ISI.
排除标准
- •Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy in the past year;
- •Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy;
- •Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
- •Opioid or barbiturate use 10+ days a month;
- •Unable or unwilling to follow a treatment program that relies on written and audio file materials;
- •Not having a smartphone.
结局指标
主要结局
Daily Diary Satisfaction Scores
时间窗: Month 3
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
时间窗: Month 3
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Number of Days Participants Used Diary
时间窗: Up to Month 3
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
Number of Patients Enrolled in the Study
时间窗: Baseline
Measure of feasibility.
Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day
时间窗: Up to Month 3
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
次要结局
未报告次要终点