Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2011-03-31
2013-12-31
Brief Summary
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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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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brief intervention
Behavioural brief intervention delivered by GP
Brief intervention
Structured behavioural Brief intervention given by trained GPs
Business as usual
Business as usual according to individual GP
Business as usual
GPs to treat patient as they have until now based on best established practice
Chronic headache control
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Screening and outcome evaluation only
No additional intervention
Population control
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Screening and outcome evaluation only
No additional intervention
Interventions
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Brief intervention
Structured behavioural Brief intervention given by trained GPs
Business as usual
GPs to treat patient as they have until now based on best established practice
Screening and outcome evaluation only
No additional intervention
Screening and outcome evaluation only
No additional intervention
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
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University of Oslo
OTHER
University Hospital, Akershus
OTHER
Responsible Party
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Christofer Lundqvist
Principal investigator/Project leader
Principal Investigators
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Christofer Lundqvist, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Akershus University Hospital and University of Oslo
Locations
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Akershus University Hospital
Lørenskog, , Norway
Dept of general medicine, University of Oslo
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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BIMOH
Identifier Type: -
Identifier Source: org_study_id