Randomization
headache, ’
SECONDARY, BLIND
Patients were randomized 1:1 to either TaU or TaU + MIND using a computer-generated list of random numbers. The study neurologist who enrolled the patients and followed them (D.D.) was not involved in the randomization procedure and remained blind to allocation. A single researcher (A.R.) prepared the randomization list and a set of opaque envelopes two months before the study beginning. Mindfulness sessions were administered by the second study neurologist (L.G., a leading expert in mindfulness and other behavioral treatment for headache). A.R. and the other researchers randomized patients to the two groups and handled data collection.After the screening visit, on the second day of withdrawal, patients meeting the selection criteria were asked to voluntarily join the study. Those who accepted signed an informed consent form and were randomized. The consent for fully explained the study purpose and the fact that the evaluating neurologist was blind to patients’ allocation. Therefore, at each follow-up, data referred to primary and secondary endpoints were collected by one of the researchers, and patients were reminded not to disclose their allocation to TaU or TaU + MIND to the study neurologist who performed the clinical evaluations (D.D.).