NCT04276142Completed
Effectiveness of a Dialogue-based Online Intervention Against Migraine
Effectiveness of the Unguided Online Program Ceprica for the Treatment of Migraine: a Double-blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Sept 2024
Brief summary (registry, in English)
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 migraine. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 321 (actual)
- First submitted
- 17 Feb 2020
- Start date
- 5 Jun 2023
- Primary completion date
- 20 Aug 2024
- Lead sponsor
- Gaia AG
- Diseases
- Migraine
- NCT number
- NCT04276142
What you commit to
- Study type: Interventional
- Participants enrolled: 321
- From 5 Jun 2023 to the primary completion date, 20 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 substance use disorder
Other
- patients with incomplete headache diaries at baseline (\>6 non-consecutive days within 28 days missing)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GAIA Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.