NCT04276142

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Gaia AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Migraine

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	active control intervention (additional to treatment as usual)	the active control intervention contains psychoeducational content regarding migraine

Timeline

• Start date: 2023-06-05
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2020-02-19
• Last updated: 2024-09-05

Locations

1 site across 1 country: Germany