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Brief Intervention for Medication Overuse Headache (BIMOH)

This study has been completed.
University of Oslo
Information provided by (Responsible Party):
Christofer Lundqvist, University Hospital, Akershus Identifier:
First received: March 14, 2011
Last updated: December 29, 2015
Last verified: December 2015

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

Condition Intervention
Medication-overuse Headache
Chronic Headache
Behavioral: Brief intervention
Other: Business as usual
Other: Screening and outcome evaluation only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual

Resource links provided by NLM:

Further study details as provided by Christofer Lundqvist, University Hospital, Akershus:

Primary Outcome Measures:
  • Number of medication days per month [ Time Frame: 3 months ]
  • Number of headache days per month [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Proportion significantly improved [ Time Frame: 3 month ]
    proportion improved >50% and >25% in terms of no headache days/month

  • Headache medication days per month (diary reported) [ Time Frame: 3 months ]
  • Headache days/month (diary reported) [ Time Frame: 3 months ]
  • Average headache intensity (VAS) [ Time Frame: 3 months ]
  • Quality of life [ Time Frame: 3 months ]
  • Self-reported health related costs [ Time Frame: 3 months ]
  • Long term follow up of same outcomes as above plus relapse rate [ Time Frame: 12 months ]
  • Headache index [ Time Frame: 3 months ]
    Headache intensity x frequency x duration

  • Follow up of same outcomes as for 3 months [ Time Frame: 6 months ]
    Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.

Enrollment: 123
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brief intervention
Behavioural brief intervention delivered by GP
Behavioral: Brief intervention
Structured behavioural Brief intervention given by trained GPs
Placebo Comparator: Business as usual
Business as usual according to individual GP
Other: 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
Other: 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
Other: Screening and outcome evaluation only
No additional intervention

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).


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01314768

Akershus University Hospital
Lørenskog, Norway
Dept of general medicine, University of Oslo
Oslo, Norway
Sponsors and Collaborators
University Hospital, Akershus
University of Oslo
Principal Investigator: Christofer Lundqvist, MD, PhD Akershus University Hospital and University of Oslo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christofer Lundqvist, Principal investigator/Project leader, University Hospital, Akershus Identifier: NCT01314768     History of Changes
Other Study ID Numbers: BIMOH
Study First Received: March 14, 2011
Last Updated: December 29, 2015

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Secondary
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases processed this record on May 25, 2017