Brief Intervention for Medication Overuse Headache (BIMOH)
RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
The investigators will perform a cluster randomised controlled study of Brief intervention (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to perform a structured brief intervention after identifying patients with probable MOH using the severity of dependence scale. The control arm will include patients of GPs who have not been trained in BI. Patients will be recruited by prior short postal screening of patients listed on the GPs patient lists.
The hypothesis is that BI will lead to improvement of medication-overuse and chronic headache as compared to no BI.
Main outcomes are:
- number of medication days per month
- number of headache days per month
- headache index
研究概览
地位
详细说明
123 cases in all included (75 in intervention/placebo control arms and 48 in non-intervention Control arms) 19 did not meet predefined inclusion criteria for the different arms (5 and 8 in intervention arm and placebo arm respectively, 4 and 2 in chronic headache Control and population Control respectively)
1 case was lost to follow up in each of the 4 Groups prior to first assessment. Thus 60 cases remained in intervention/placebo Control arms (24 in intervention and 36 in placebo Control) and 40 in non intervention Control arms (15 chronic headache Controls, 25 population Controls).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Lørenskog、挪威
- Akershus University Hospital
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Oslo、挪威
- Dept of general medicine, University of Oslo
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18-50 years of age
- Screening positive for possible chronic headache (> 10 headache days per month) (not for population control arm)
- Screening positive for possible medication-overuse (> 15 medication days per month) (not for chronic headache control arm)
Exclusion Criteria:
- Other complicating pain with medication treatment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Brief intervention
Behavioural brief intervention delivered by GP
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Structured behavioural Brief intervention given by trained GPs
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|
安慰剂比较：Business as usual
Business as usual according to individual GP
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GPs to treat patient as they have until now based on best established practice
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其他：Chronic headache control
Screening and outcome control only.
Non-intervention Control, screened and followed-up at final time point
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No additional intervention
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其他：Population control
Screening and outcome control only.
Non-intervention Control, screened and followed-up at final time point
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No additional intervention
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of medication days per month
大体时间：3 months
|
3 months
|
|
Number of headache days per month
大体时间：3 months
|
3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
生活质量
大体时间：3个月
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3个月
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Proportion significantly improved
大体时间：3 month
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proportion improved >50% and >25% in terms of no headache days/month
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3 month
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Headache medication days per month (diary reported)
大体时间：3 months
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3 months
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|
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Headache days/month (diary reported)
大体时间：3 months
|
3 months
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Average headache intensity (VAS)
大体时间：3 months
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3 months
|
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Self-reported health related costs
大体时间：3 months
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3 months
|
|
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Long term follow up of same outcomes as above plus relapse rate
大体时间：12 months
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12 months
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Headache index
大体时间：3 months
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Headache intensity x frequency x duration
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3 months
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Follow up of same outcomes as for 3 months
大体时间：6 months
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Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.
|
6 months
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合作者和调查者
调查人员
- 首席研究员：Christofer Lundqvist, MD, PhD、Akershus University Hospital and University of Oslo
出版物和有用的链接
一般刊物
- Lundqvist C, Gossop M, Russell MB, Straand J, Kristoffersen ES. Severity of Analgesic Dependence and Medication-overuse Headache. J Addict Med. 2019 Sep/Oct;13(5):346-353. doi: 10.1097/ADM.0000000000000504.
- Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Predictors of successful primary care detoxification treatment for medication-overuse headache. Acta Neurol Scand. 2017 Nov;136(5):486-494. doi: 10.1111/ane.12759. Epub 2017 Mar 28.
- Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. J Neurol. 2016 Feb;263(2):344-353. doi: 10.1007/s00415-015-7975-1. Epub 2015 Dec 8.
- Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Disability, anxiety and depression in patients with medication-overuse headache in primary care - the BIMOH study. Eur J Neurol. 2016 Jan;23 Suppl 1:28-35. doi: 10.1111/ene.12850.
- Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention for medication-overuse headache in primary care. The BIMOH study: a double-blind pragmatic cluster randomised parallel controlled trial. J Neurol Neurosurg Psychiatry. 2015 May;86(5):505-12. doi: 10.1136/jnnp-2014-308548. Epub 2014 Aug 11.
- Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Study protocol: brief intervention for medication overuse headache--a double-blinded cluster randomised parallel controlled trial in primary care. BMC Neurol. 2012 Aug 10;12:70. doi: 10.1186/1471-2377-12-70.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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