Brief Intervention for Medication Overuse Headache (BIMOH)

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