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Brief Intervention for Medication Overuse Headache (BIMOH)

Primary Purpose

Medication-overuse Headache, Chronic Headache

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Brief intervention
Business as usual
Screening and outcome evaluation only
Screening and outcome evaluation only
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication-overuse Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Akershus University Hospital
  • Dept of general medicine, University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Other

Other

Arm Label

Brief intervention

Business as usual

Chronic headache control

Population control

Arm Description

Behavioural brief intervention delivered by GP

Business as usual according to individual GP

Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point

Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point

Outcomes

Primary Outcome Measures

Number of medication days per month
Number of headache days per month

Secondary Outcome Measures

Proportion significantly improved
proportion improved >50% and >25% in terms of no headache days/month
Headache medication days per month (diary reported)
Headache days/month (diary reported)
Average headache intensity (VAS)
Quality of life
Self-reported health related costs
Long term follow up of same outcomes as above plus relapse rate
Headache index
Headache intensity x frequency x duration
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.

Full Information

First Posted
March 14, 2011
Last Updated
December 29, 2015
Sponsor
University Hospital, Akershus
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT01314768
Brief Title
Brief Intervention for Medication Overuse Headache
Acronym
BIMOH
Official Title
RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication-overuse Headache, Chronic Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief intervention
Arm Type
Active Comparator
Arm Description
Behavioural brief intervention delivered by GP
Arm Title
Business as usual
Arm Type
Placebo Comparator
Arm Description
Business as usual according to individual GP
Arm Title
Chronic headache control
Arm Type
Other
Arm Description
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Arm Title
Population control
Arm Type
Other
Arm Description
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention
Intervention Description
Structured behavioural Brief intervention given by trained GPs
Intervention Type
Other
Intervention Name(s)
Business as usual
Intervention Description
GPs to treat patient as they have until now based on best established practice
Intervention Type
Other
Intervention Name(s)
Screening and outcome evaluation only
Intervention Description
No additional intervention
Intervention Type
Other
Intervention Name(s)
Screening and outcome evaluation only
Intervention Description
No additional intervention
Primary Outcome Measure Information:
Title
Number of medication days per month
Time Frame
3 months
Title
Number of headache days per month
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion significantly improved
Description
proportion improved >50% and >25% in terms of no headache days/month
Time Frame
3 month
Title
Headache medication days per month (diary reported)
Time Frame
3 months
Title
Headache days/month (diary reported)
Time Frame
3 months
Title
Average headache intensity (VAS)
Time Frame
3 months
Title
Quality of life
Time Frame
3 months
Title
Self-reported health related costs
Time Frame
3 months
Title
Long term follow up of same outcomes as above plus relapse rate
Time Frame
12 months
Title
Headache index
Description
Headache intensity x frequency x duration
Time Frame
3 months
Title
Follow up of same outcomes as for 3 months
Description
Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christofer Lundqvist, MD, PhD
Organizational Affiliation
Akershus University Hospital and University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
Country
Norway
Facility Name
Dept of general medicine, University of Oslo
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
30724760
Citation
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.
Results Reference
derived
PubMed Identifier
28369734
Citation
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.
Results Reference
derived
PubMed Identifier
26645391
Citation
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.
Results Reference
derived
PubMed Identifier
26563095
Citation
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.
Results Reference
derived
PubMed Identifier
25112307
Citation
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.
Results Reference
derived
PubMed Identifier
22883540
Citation
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.
Results Reference
derived

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Brief Intervention for Medication Overuse Headache

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