Brief Intervention for Medication Overuse Headache (BIMOH)

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Christofer Lundqvist, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01314768
First received: March 14, 2011
Last updated: December 29, 2015
Last verified: December 2015

March 14, 2011
December 29, 2015
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
  • Follow up of same outcomes as for 3 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.
  • 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
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

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).

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
    No additional intervention
  • Active Comparator: Brief intervention
    Behavioural brief intervention delivered by GP
    Intervention: Behavioral: Brief intervention
  • Placebo Comparator: Business as usual
    Business as usual according to individual GP
    Intervention: Other: Business as usual
  • Chronic headache control
    Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
    Intervention: Other: Screening and outcome evaluation only
  • Population control
    Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
    Intervention: Other: Screening and outcome evaluation only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
December 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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01314768
BIMOH
No
Not Provided
Not Provided
Christofer Lundqvist, University Hospital, Akershus
University Hospital, Akershus
University of Oslo
Principal Investigator: Christofer Lundqvist, MD, PhD Akershus University Hospital and University of Oslo
University Hospital, Akershus
December 2015

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