Clinical trial NCT04276142: Effectiveness of a Dialogue-based Online Intervention Against Migraine
Official title: Effectiveness of the Unguided Online Program Ceprica for the Treatment of Migraine: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: ceprica
online intervention
headache
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
First posted: 2020-02-19
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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 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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of days with migraine headache
timeFrame: 3 months
Secondary outcomes:
measure: Migraine-related disability
timeFrame: 3 months
measure: Use of acute migraine medication
timeFrame: 3 months
measure: Number of moderate/severe headache days
timeFrame: 3 months
measure: Migraine days responder rate
timeFrame: 3 months
measure: Headache-related pain intensity
timeFrame: 3 months
measure: Functional impairment due to migraine
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: 3 months
measure: Anxiety symptoms
timeFrame: 3 months
measure: Migraine attacks
timeFrame: 3 months
Other outcomes:
measure: Sociodemographic variables
timeFrame: Baseline Assessment
measure: Treatment Satisfaction
timeFrame: T1 Assessment
measure: Healthy lifestyle
timeFrame: 3 months
Locations:
city: Hamburg
country: Germany
facility: GAIA
Study officials:
affiliation: Gaia AG
name: Gitta Jacob, PD PhD
role: PRINCIPAL_INVESTIGATOR
References: