Brief Intervention for Medication Overuse Headache
BIMOH
RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
1 other identifier
interventional
123
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 30, 2015
December 1, 2015
1.7 years
March 14, 2011
December 29, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of medication days per month
3 months
Number of headache days per month
3 months
Secondary Outcomes (9)
Proportion significantly improved
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
- +4 more secondary outcomes
Study Arms (4)
Brief intervention
ACTIVE COMPARATORBehavioural brief intervention delivered by GP
Business as usual
PLACEBO COMPARATORBusiness as usual according to individual GP
Chronic headache control
OTHERScreening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Population control
OTHERScreening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Interventions
Structured behavioural Brief intervention given by trained GPs
GPs to treat patient as they have until now based on best established practice
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Other complicating pain with medication treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Akershuslead
- University of Oslocollaborator
Study Sites (2)
Akershus University Hospital
Lørenskog, Norway
Dept of general medicine, University of Oslo
Oslo, Norway
Related Publications (6)
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.
PMID: 30724760DERIVEDKristoffersen 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.
PMID: 28369734DERIVEDKristoffersen 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.
PMID: 26645391DERIVEDKristoffersen 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.
PMID: 26563095DERIVEDKristoffersen 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.
PMID: 25112307DERIVEDKristoffersen 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.
PMID: 22883540DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christofer Lundqvist, MD, PhD
Akershus University Hospital and University of Oslo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator/Project leader
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 15, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2012
Study Completion
December 1, 2013
Last Updated
December 30, 2015
Record last verified: 2015-12