Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of Headache Days Per Month
研究概览
简要总结
To evaluate the effect of Introvision, a mental and emotional self-regulation-technique developed by Angelika C. Wager, as migraine preventative compared to a waiting list group.
详细描述
Randomized, single-center, waiting-list control group study: Introvision as preventative in Migraine
Randomized, single center, waiting-list group control study to evaluate the effect of Introvison, a mental and emotional self regulation method to reduce headache days in patients with migraine, migraine and tension type headache and chronic migraine. The number of headache days 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Episodic migraine with at least 5 headache days per month, episodic migraine and tension type headache with at least 5 migraine headache days per month, chronic migraine
- •Stable prophylactic headache medication
- •Stable non-medication headache prophylaxis (sports, relaxation techniques, ...)
- •Informed consent
排除标准
- •Other causes of headache, symptomatic headaches
- •Other primary headaches such as Cluster headache, trigeminal neuralgia, idiopathic facial pain, new daily persistent headache
- •Severe depression (more than 13 points in the Beck Depression inventory fast screen (BDI-FS)
- •Drug - or alcohol abuse
- •Non-compliance, especially significant missing entries in the headache diaries
- •Active psychosis
研究组 & 干预措施
non-waiting list group
Intervention: Introvision: mental and emotional self-regulation
干预措施: Introvision: mental and emotional self-regulation (Behavioral)
waiting list group
Intervention: Introvision: mental and emotional self-regulation
Introvision is teached to participants of the waiting-list group at least 6 weaks or more after first group
干预措施: Introvision: mental and emotional self-regulation (Behavioral)
结局指标
主要结局
Number of Headache Days Per Month
时间窗: approximately 4 months, as the course to learn Introvision and the three individual sessions will take nearly 2 months to be completed, and headaches per month will be assessed in the month 3 months after the last session of Introvision.
The number of headache days per month 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.
次要结局
- Headache Intensity(approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session)
- Acute Medication Per Month(approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session)
- Number of Headache Days Per Month in Pooled Groups Analysis Before and 3 Months After Introvision as Parameter for the Efficacy of Introvision(approximately 5-6 months)
- Headache Management Self-efficacy Scale-German-short Form (HMSE-G-SF)(approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session)
- Headache-Impact Test 6, HIT-6(approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session)
- Overall Satisfaction of Patients(approximately 5 - 6 months, baseline before introvision training and 3 three months after the last introvision session)
研究者
Dr. Monika Empl
Principal Investigator
Ludwig-Maximilians - University of Munich