Effectiveness of a Dialogue-based Online Intervention Against A) Tension-type Headache and B) Migraine
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Migraine
- Tension Type Headache
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: two sub-studies: (A) tension-type headache (N = 260), (B) migrane (N = 260) each with two arms, intervention versus placebo controlMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
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 psychologica...
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 divided into two sub-trials: (A) tension-type headache and (B) 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 a control group, in which they receive online evidence-based information regarding headache and continue their usual care or an intervention group that may also use care as usual and in addition receives the online intervention ceprica. Data are collected at baseline (T0), and three months later (T1).
Tracking Information
- NCT #
- NCT04276142
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Gitta Jacob, PD PhD Gaia AG
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