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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
321
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.
the active control intervention contains psychoeducational content regarding migraine
GAIA
Hamburg, Germany
Number of days with migraine headache
Change since baseline in migraine headache days per 28 days; assessed via diary
Time frame: 3 months
Migraine-related disability
assessed via the Headache Impact Test (HIT-6); scale range from 36-78
Time frame: 3 months
Use of acute migraine medication
change from baseline in days with use of acute migraine medication per 28 days; assessed via diary
Time frame: 3 months
Number of moderate/severe headache days
Change since baseline in moderate/severe headache days per 28 days; assessed via diary
Time frame: 3 months
Migraine days responder rate
Proportion of participants achieving at least 50% reduction from baseline in migraine days
Time frame: 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
Time frame: 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
Time frame: 3 months
Depressive symptoms
measured via Patient Health Questionnaire (PHQ-9); scale range: 0 to 27
Time frame: 3 months
Anxiety symptoms
measured via Generalized Anxiety Disorder Assessment (GAD-7); scale range: 0 to 21
Time frame: 3 months
Migraine attacks
Change since baseline in migraine attacks per 28 days; assessed via diary
Time frame: 3 months
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