MigraineEU-OPTMiNCT04276142
Effectiveness of a Dialogue-based Online Intervention Against Migraine
A study testing ceprica (additional to treatment as usual) in people with Migraine, run by Gaia AG at 1 site in Germany.
Trial 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 migraine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- ceprica (additional to treatment as usual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2023to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Unguided Online Program Ceprica for the Treatment of Migraine: a Double-blind Randomized Controlled Trial
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.
Read the 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 migraine. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective.
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
- Migraine
- Being tested
- ceprica (additional to treatment as usual), active control intervention (additional to treatment as usual)
- Keywords
- ceprica, online intervention, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceprica (additional to treatment as usual)Behavioural
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)Behavioural
the active control intervention contains psychoeducational content regarding migraine
| Study group | Role | What they receive |
|---|---|---|
| Migraine - ceprica | Experimental | online program: ceprica in addition to treatment as usual Receives: Behavioral: ceprica (additional to treatment as usual) |
| Migraine - active control intervention | Other | active control intervention: psychoeducation in addition to treatment as usual Receives: Behavioral: active control intervention (additional to treatment as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with migraine headache
Change since baseline in migraine headache days per 28 days; assessed via diary
Measured: 3 months
Secondary outcomes (9)
Migraine-related disability
assessed via the Headache Impact Test (HIT-6); scale range from 36-78
Measured: 3 months
Use of acute migraine medication
change from baseline in days with use of acute migraine medication per 28 days; assessed via diary
Measured: 3 months
Number of moderate/severe headache days
Change since baseline in moderate/severe headache days per 28 days; assessed via diary
Measured: 3 months
Migraine days responder rate
Proportion of participants achieving at least 50% reduction from baseline in migraine days
Measured: 3 months
Headache-related pain intensity
assessed via a categorical, four-point verbal rating scale (no pain, mild pain, moderate pain, severe pain) on each day of each 28-day diary period
Measured: 3 months
Functional impairment due to migraine
Assessed via the Functional Impairment Scale on each day of the 28-day diary period; scale range: 0-3
Measured: 3 months
Depressive symptoms
measured via Patient Health Questionnaire (PHQ-9); scale range: 0 to 27
Measured: 3 months
Anxiety symptoms
measured via Generalized Anxiety Disorder Assessment (GAD-7); scale range: 0 to 21
Measured: 3 months
Migraine attacks
Change since baseline in migraine attacks per 28 days; assessed via diary
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start5 Jun 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) psychoeducational active control intervention in addition to treatment-as-usual
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gitta Jacob, PD PhD, Principal investigator, Gaia AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276142
- Sponsor's protocol ID
- ceprica trial
- Acronym
- EU-OPTMi
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2020
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Unguided Online Program Ceprica for the Treatment of Migraine: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04276142
- Acronym / sponsor ID
- EU-OPTMi / ceprica trial
- Conditions
- Migraine
- Keywords
- ceprica, online intervention, headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 migraine. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) psychoeducational active control intervention in addition to treatment-as-usual
| Arm | Type | Receives |
|---|---|---|
| Migraine - ceprica | Experimental | Behavioral: ceprica (additional to treatment as usual)online program: ceprica in addition to treatment as usual |
| Migraine - active control intervention | Other | Behavioral: active control intervention (additional to treatment as usual)active control intervention: psychoeducation in addition to treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Migraine - ceprica |
| active control intervention (additional to treatment as usual)the active control intervention contains psychoeducational content regarding migraine | Behavioural | Migraine - active control intervention |
Primary outcome
Number of days with migraine headache
Time frame: 3 months
Change since baseline in migraine headache days per 28 days; assessed via diary
9 secondary outcomes
Migraine-related disability
Time frame: 3 months
Use of acute migraine medication
Time frame: 3 months
Number of moderate/severe headache days
Time frame: 3 months
Migraine days responder rate
Time frame: 3 months
Headache-related pain intensity
Time frame: 3 months
Functional impairment due to migraine
Time frame: 3 months
Depressive symptoms
Time frame: 3 months
Anxiety symptoms
Time frame: 3 months
Migraine attacks
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitta Jacob, PD PhD principal investigator
Gaia AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ceprica (additional to treatment as usual) in people with Migraine, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with migraine headache (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.