Brief Intervention for Medication Overuse Headache (BIMOH)

December 29, 2015 updated by: Christofer Lundqvist, University Hospital, Akershus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lørenskog, Norway
        • Akershus University Hospital
      • Oslo, Norway
        • Dept of general medicine, University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Brief intervention
Behavioural brief intervention delivered by GP
Behavioral: Brief intervention
Structured behavioural Brief intervention given by trained GPs
Placebo Comparator: Business as usual
Business as usual according to individual GP
Other: Business as usual
GPs to treat patient as they have until now based on best established practice
Other: Chronic headache control
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Other: Screening and outcome evaluation only
No additional intervention
Other: Population control
Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point
Other: Screening and outcome evaluation only
No additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of medication days per month
Time Frame: 3 months
3 months
Number of headache days per month
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 3 months
3 months
Proportion significantly improved
Time Frame: 3 month
proportion improved >50% and >25% in terms of no headache days/month
3 month
Headache medication days per month (diary reported)
Time Frame: 3 months
3 months
Headache days/month (diary reported)
Time Frame: 3 months
3 months
Average headache intensity (VAS)
Time Frame: 3 months
3 months
Self-reported health related costs
Time Frame: 3 months
3 months
Long term follow up of same outcomes as above plus relapse rate
Time Frame: 12 months
12 months
Headache index
Time Frame: 3 months
Headache intensity x frequency x duration
3 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Christofer Lundqvist, MD, PhD, Akershus University Hospital and University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIMOH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Headache

Clinical Trials on Brief intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe