NCT01314768

Brief Intervention for Medication Overuse Headache

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Medication-overuse Headache
• Chronic Headache

Interventions

Type	Name	Description
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
OTHER	Screening and outcome evaluation only	No additional intervention

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-11-01
• Completion: 2013-12-01
• First posted: 2011-03-15
• Last updated: 2015-12-30

Locations

2 sites across 1 country: Norway