RELAXaHEAD for Headache Patients (Phase I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
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 headaches. 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. This 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAX for use with headache patients. 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 headache (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache 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
- •Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
- •4 or more headache days per month
排除标准
- •Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy for Migraine 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 recorded materials
- •Not having a smartphone
结局指标
主要结局
Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
时间窗: 90 Days
Measure of feasibility
Number of days spent logging headache data as determined by entries into the RELAXaHEAD app
时间窗: 90 Days
Measure of feasibility
Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality
时间窗: Baseline
Measure of acceptability
Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app
时间窗: 90 Days
Measure of feasibility
次要结局
未报告次要终点