Brief Intervention for Medication Overuse Headache

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual

Conditions
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Medication-overuse Headache, Chronic Headache

Intervention / Treatment
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* Behavioral: Brief intervention
* Other: Business as usual
* Other: Screening and outcome evaluation only
* Other: Screening and outcome evaluation only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief intervention<br>Behavioural brief intervention delivered by GP | Behavioral: Brief intervention<br>* Structured behavioural Brief intervention given by trained GPs<br>|
| Placebo Comparator: Business as usual<br>Business as usual according to individual GP | Other: Business as usual<br>* GPs to treat patient as they have until now based on best established practice<br>|
| Other: Chronic headache control<br>Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point | Other: Screening and outcome evaluation only<br>* No additional intervention<br>|
| Other: Population control<br>Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point | Other: Screening and outcome evaluation only<br>* No additional intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of medication days per month |  | 3 months | 
| Number of headache days per month |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion significantly improved | proportion improved >50% and >25% in terms of no headache days/month | 3 month | 
| Headache medication days per month (diary reported) |  | 3 months | 
| Headache days/month (diary reported) |  | 3 months | 
| Average headache intensity (VAS) |  | 3 months | 
| Quality of life |  | 3 months | 
| Self-reported health related costs |  | 3 months | 
| Long term follow up of same outcomes as above plus relapse rate |  | 12 months | 
| Headache index | Headache intensity x frequency x duration | 3 months | 
| Follow up of same outcomes as for 3 months | Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months. | 6 months |