Brief Intervention for Medication Overuse Headache (BIMOH)

U

University Hospital, Akershus

Status

Completed

Conditions

Chronic Headache
Medication-overuse Headache

Treatments

Behavioral: Brief intervention
Other: Business as usual
Other: Screening and outcome evaluation only

Study type

Interventional

Funder types

Other

Identifiers

NCT01314768
BIMOH

Details and patient eligibility

About

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

Full 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).

Enrollment

123 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

123 participants in 4 patient groups, including a placebo group

Brief intervention
Active Comparator group
Description:
Behavioural brief intervention delivered by GP
Treatment:
Behavioral: Brief intervention
Business as usual
Placebo Comparator group
Description:
Business as usual according to individual GP
Treatment:
Other: Business as usual
Chronic headache control
Other group
Description:
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Treatment:
Other: Screening and outcome evaluation only
Population control
Other group
Description:
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Treatment:
Other: Screening and outcome evaluation only

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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