Effectiveness of a Dialogue-based Online Intervention Against A) Tension-type Headache and B) Migraine
Effectiveness of a Dialogue-based Online Intervention Against A) Tension-type Headache and B) Migraine
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 A) tension-type headache and B) migraine.

 The study aims to test the hypothesis that ceprica has a higher positive impact on
 psychometric parameters than the active control. 520 patients with tension-type headache or
 migraine (260 participants with each indication) will be included and randomized to two
 groups: (1) a control group, that will be provided with an online intervention, that will
 teach about evidence-based content regarding headache or (2) an intervention group that
 immediately receives access to the online program ceprica. The primary endpoints are
 self-reported days with headache and self-reported mean pain intensity.
Tension-type headache and migraine are common in the German population and lead to a
 decreased quality of life as well as high economic consequences. Cognitive behavioural
 therapy has shown to be effective in the treatment of all types of headache, especially the
 chronic ones. 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 an active control group 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 is delivered via the internet and protected
 by individually assigned passwords. The active control will receive an online intervention
 that contains evidence-based information regarding headache.

 This randomised controlled trial will include 520 patients with tension-type headache or
 migraine (260 participants for each indication). Participants will be recruited via a website
 containing relevant information about the study. Participants will be randomly assigned to
 either (1) a control group, in which they receive online evidence-based information regarding
 headache and continue their usual care or (2) an intervention group that may also use care as
 usual and in addition receives the online intervention ceprica. Measurements are collected at
 baseline (T0), and three months later (T1).
Inclusion Criteria:

 -  18 - 65 years old

 -  Completion of headache-diary at least 11 of 14 days

 -  tension-type headache or migraine for at least two days in two weeks with a minimum
 intensity of 4/10

 -  Informed consent

 -  competence in the german language

 -  access to the internet through smartphone/computer

 Exclusion Criteria:

 - Present diagnosis of secondary headache disorder (apart from headaches due to medication
 overuse)