Effectiveness of a Dialogue-based Online Intervention Against Migraine
NCT ID: NCT04276142
Last Updated: 2024-09-05
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
321 participants
INTERVENTIONAL
2023-06-05
2024-08-20
Brief Summary
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The study aims to test the hypothesis that ceprica has a greater positive impact on migraine symptoms than an active control intervention providing psychoeducational content. Patients fulfilling ICHD-criteria for migraine will be randomized and allocated to either an intervention group, receiving ceprica in addition to treatment as usual, or a control group, which receives access to an active control intervention in addition to treatment as usual. The primary endpoint is the number of migraine days per month.
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Detailed Description
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In this study, the treatment effects of a novel dialogue-based online intervention compared to a psychoeducational control intervention will be investigated. The interventional online program ceprica contains elements of cognitive behavioural therapy that address specific approaches in the management of pain, integrated in an individually tailored dialogue that is based on the responses given in the program. The intervention ceprica, as well as the psychoeducational control intervention, aer both delivered via the internet and protected by individually assigned passwords.
This randomised controlled trial will include 306 patients with migraine. Participants will be recruited via a website containing relevant information about the study. Participants will be randomly assigned in a 1:1 ratio to either a control group, in which they continue their usual treatment and receive access to a psychoeducational control intervention, or an intervention group who may also use treatment as usual and in addition receives the online intervention ceprica. Data are collected at baseline (T0) and three months after allocation (T1).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Migraine - ceprica
online program: ceprica in addition to treatment as usual
ceprica (additional to treatment as usual)
ceprica is a dialogue-based online psychological intervention for patients with migraine. This intervention includes elements that address pain management, pain reduction etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual treatment.
Migraine - active control intervention
active control intervention: psychoeducation in addition to treatment as usual
active control intervention (additional to treatment as usual)
the active control intervention contains psychoeducational content regarding migraine
Interventions
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ceprica (additional to treatment as usual)
ceprica is a dialogue-based online psychological intervention for patients with migraine. This intervention includes elements that address pain management, pain reduction etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual treatment.
active control intervention (additional to treatment as usual)
the active control intervention contains psychoeducational content regarding migraine
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Gitta Jacob, PD PhD
Role: PRINCIPAL_INVESTIGATOR
Gaia AG
Locations
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GAIA
Hamburg, , Germany
Countries
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Other Identifiers
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ceprica trial
Identifier Type: -
Identifier Source: org_study_id
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