Status:
COMPLETED
Effectiveness of a Dialogue-based Online Intervention Against Migraine
Lead Sponsor:
Gaia AG
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial was designed to evaluate the effectiveness of a dialogue-based online intervention (ceprica) that provides information regarding cognitive behavioural therapy (CBT) in patients with migrain...
Detailed Description
Migraine is common in the German population and leads to a decreased quality of life as well as high economic consequences. Cognitive behavioural therapy has shown to be effective in the treatment of ...
Eligibility Criteria
Inclusion
- age 18-65 at the time of screening
- fulfill diagnostic criteria of migraine (ICD-10: G43.0 or G43.1, confirmed either by upload of a medical document issued by a medical specialist or by a diagnostic phone/video call with a study physician who is experienced in headache diagnostics)
- age at onset of migraine \<50y
- Migraine is present for at least 12 months at the time of study entry
- 4-14 migraine headache days per 28 days
- able and willing to give signed informed consent
- sufficient language skills in German
Exclusion
- currently receiving preventive migraine medication within 60 days of T0, or planning to start another preventive treatment during the course of the study
- routinely taking, or planning to take, gepant-type acute migraine medication (e.g., rimegepant)
- Botulinum toxin A and B administered in the head or neck area within 4 months prior to T0
- patients with a history of failure to respond to 3 or more classes of migraine preventive treatments with good scientific evidence
- patients with regular intake of analgesics for other reasons than headache (e.g., chronic back pain, (rheumatoid) arthritis, cancer, injuries/accidents)
- patients with incomplete headache diaries at baseline (\>6 non-consecutive days within 28 days missing)
- patients with substance use disorder
Key Trial Info
Start Date :
June 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2024
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT04276142
Start Date
June 5 2023
End Date
August 20 2024
Last Update
September 5 2024
Active Locations (1)
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1
GAIA
Hamburg, Germany, 22085