An interventional study of Educational programme in Secondary Headache Disorders and Medication-overuse Headache, sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Esbjerg Hospital - University Hospital of Southern Denmark · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the influence of personality profiles in patients with MOH and to evaluate the effect of a custom-made educational programme as an add-on to standard treatment as compared to standard treatment alone in MOH patients using a randomized controlled trial (RCT) design.
Worldwide, two percent of the population suffers from medication-overuse headache (MOH), a paradox condition where the headache is caused by overuse of headache medication. Common treatment is withdrawal, but there is no consensus on what constitutes the best treatment.
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.
162 studies on the registry are indexed under Headache Disorders; 40 are open to participants now.
This study's enrollment of 98 is above the median of 60 across 103 interventional studies indexed under Headache Disorders.
Browse Headache Disorders studies →Esbjerg Hospital - University Hospital of Southern Denmark is the lead sponsor of 45 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1: Educational programme + standard treatment
Behavioral: Educational programme
Standard treatment
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.
Headache frequency measured by self-reported headache diary on number of days with headache previous month
Time frame: baseline-36 weeks follow-up
NEO-FFI-3 personality test
self reported. 63 items. Each item scores using a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)
Time frame: Baseline
Coping Strategies
CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Pain Intensity
VAS (0: No pain, 10: Pain as bad as it can be)
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Bothersomeness
VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Patient satisfaction
Questionnarire
Time frame: Baseline, Post intervention (16 weeks), Follow-up (36 weeks)
Medication intake
self reported intake (type, name of medication, dosis)
Time frame: baseline, Post intervention (16 weeks) and Follow-up (36 weeks)
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Esbjerg Hospital - University Hospital of Southern Denmark