Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT01314768
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2011-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief Intervention for Medication Overuse Headache
Sponsor:
University Hospital, Akershus
Organization:
Study Overview
Official Title:
RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIMOH
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
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: