Abstract text (incl. figure legends and references)

Background. The most effective treatment of migraine is interdisciplinary. However it has very limited availability. This study is the first interventional study to test the operation and effectiveness of digital interventions compared to the usual interdisciplinary treatment (treatment standard).

Question. Is digitally mediated treatment as effective as the conventional one and does it allow to treat more patients while saving the workload of professionals?

Methods. The study is approved by the Research Ethics Committee of the University of Tartu and registered at ClinicalTrials.gov. This is a multi-centre, open-label, prospective, randomized study. According to power analysis, 600 migraine patients are randomized to receive the interdisciplinary intervention for migraine in parallel groups: the study group (digital treatment group) and the control group (standard interdisciplinary treatment group or treatment standard group). Interventions are held by same specialists in 3 different areas (headache nurse counselling, cognitive-behavioural therapy, physiotherapy). Pharmacological treatment is prescribed by patient's treating neurologist, who is blinded of patients' allocation to groups.

Outcomes. The primary outcome measure is a reduction of headache days after three months of the interdisciplinary intervention program compared to baseline. Secondary outcome measures will measure changes in: number of headache days six and nine months after the intervention (follow-up); consumption of migraine acute medications; pain intensity; depression and anxiety; pain acceptance; health relates quality of life; sick-leaves; impact on the burden of migraine.

Discussion. The main importance of this innovative study design and approach is the possibility to provide evidence about effective digitized migraine treatment to much more patients with a smaller workload. This study is laying the foundation for planning further research in the area and for clinical implementations.