Brief Intervention for Medication Overuse Headache (BIMOH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Christofer Lundqvist, Akershus University College
ClinicalTrials.gov Identifier:
NCT01314768
First received: March 14, 2011
Last updated: January 11, 2013
Last verified: January 2013

March 14, 2011
January 11, 2013
March 2011
November 2012   (final data collection date for primary outcome measure)
  • Number of medication days per month [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of headache days per month [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01314768 on ClinicalTrials.gov Archive Site
  • Proportion significantly improved [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    proportion improved >50% and >25% in terms of no headache days/month
  • Headache medication days per month (diary reported) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Headache days/month (diary reported) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Average headache intensity (VAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Self-reported health related costs [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Long term follow up of same outcomes as above plus relapse rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Headache index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Headache intensity x frequency x duration
Same as current
Not Provided
Not Provided
 
Brief Intervention for Medication Overuse Headache
RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Medication-overuse Headache
  • Chronic Headache
  • Behavioral: Brief intervention
    Structured behavioural Brief intervention given by trained GPs
  • Other: Business as usual
    GPs to treat patient as they have until now based on best established practice
  • Other: Screening and outcome evaluation only
  • Other: Screening and outcome evaluation only
    No additional intervention
  • Active Comparator: Brief intervention
    Intervention: Behavioral: Brief intervention
  • Placebo Comparator: Business as usual
    Intervention: Other: Business as usual
  • Chronic headache control
    Intervention: Other: Screening and outcome evaluation only
  • Population control
    Intervention: Other: Screening and outcome evaluation only
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
August 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01314768
BIMOH
No
Christofer Lundqvist, Akershus University College
University Hospital, Akershus
University of Oslo
Principal Investigator: Christofer Lundqvist, MD, PhD Akershus University Hospital and University of Oslo
University Hospital, Akershus
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP