Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
NCT ID: NCT02768233
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2015-10-15
2019-01-31
Brief Summary
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Detailed Description
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The study consists of a RCT with MOH patients randomized to standard treatment versus standard treatment + a 12-week, 6-session educational programme as add-on. The programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups.
Primary endpoint: Headache frequency measured by self-reported headache diary on number of days with headache pre-vious month. Secondary endpoints: NEO-FFI-3 personality test, coping strategies, pain intensity, bothersomeness, patient satis-faction and reported medication intake.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Educational programme
Group 1: Educational programme + standard treatment
Educational programme
The 6-session educational programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. The standard treatment consists of withdrawal and consultations by neurologist.
Standard treatment
Standard treatment
No interventions assigned to this group
Interventions
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Educational programme
The 6-session educational programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. The standard treatment consists of withdrawal and consultations by neurologist.
Eligibility Criteria
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Inclusion Criteria
* Completed withdrawal (hospitalized of 8 days or at home).
* Age 18-65 years
* Understand and speak Danish
Exclusion Criteria
* Mental health disorders
18 Years
65 Years
ALL
No
Sponsors
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Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Responsible Party
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Louise Schlosser Mose
PhD student
Principal Investigators
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Louise S. Mose, MHS
Role: PRINCIPAL_INVESTIGATOR
Hospital of South West Jutland, Denmark
References
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Mose LS, Pedersen SS, Jensen RH, Gram B. Medication-overuse headache: The effect of a patient educational programme-A randomized controlled trial. Eur J Pain. 2020 Feb;24(2):435-447. doi: 10.1002/ejp.1500. Epub 2019 Nov 21.
Other Identifiers
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S-20140114
Identifier Type: -
Identifier Source: org_study_id
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