Clinical Trial: Brief Intervention for Medication Overuse Headache

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual

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 Summary:

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).


Sponsor: University Hospital, Akershus

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • 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


Information By: University Hospital, Akershus

Dates:
Date Received: March 14, 2011
Date Started: March 2011
Date Completion:
Last Updated: December 29, 2015
Last Verified: December 2015