Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Migraine

Background and significance Chronic Migraine is not so unusual in pediatric and adolescent age and is about 2% of population in adolescent age. The literature of the last decades confirmed the need to taking care of these patients susceptible to develop medication overuse. There are different pharmacological treatments for migraine in young patients but no one of them has specific indication for this category of patients and their efficacy reaches 30/40% leaving many side effects difficult to manage at this age. The feasibility and the effectiveness of behavioral approaches has been already documented in clinical experiences of the last decades: these approaches revealed efficacy in long-term studies and with control groups and they are totally free of unpleasant effects. Mindfulness practice is one of the most recent behavioral approaches that combined with Acceptance Commitment Therapy offer a suitable and adequate treatment for adolescent patients. These approaches make patients more conscious about their problem and able to learn techniques alternative to medications for managing pain.. Mindfulness and other behavioral therapies have done significant results in terms of clinical improvement for these patients and they are well accepted with a high adherence level. This preliminary study will be performed considering that the Covid-19 emergency reduced significantly the possibility for patients to follow sessions at the hospital and to move among the different Italian regions and the investigators organized a program with education and support by mindfulness , delivered by video sessions. According to the protocols at the Headache Center of the Besta Institute in Milan Italy, patients of this category are followed with a standardized program including: education and support for behavioral measures, behavioral sessions, by mindfulness, once per week for 45 minutes for 6 weeks which usually delivered in groups of 4 - 8 patients. This approach may be particularly useful in helping patients to obtain a better outcome. All the above discussed considerations are even more relevant in this emergency situation due to the Corona-virus pandemic phenomenon in Italy, with its consequences on mobility of patients and clinical practice. In order to promote different modalities to respond to the needs of patients suffering from this disabling condition during the emergency, exercise-based telemedicine and smartphone applications seem very appropriate, as they have been recently tested in the management of chronic pain conditions. This preliminary study will be performed considering that the Covid-19 emergency reduced significantly the mobility of patients, particularly those living in other Italian regions than Lombardy, and in view of providing an effective and somewhat innovative treatment program for this class of patients. The proposed treatment intervention is based on investigators' experience, and on published reports, but it specifically includes a home based program, visits performed as Video calls, and educational and support strategies aimed to develop skills to reduce clinical symptoms and to cope with pain by a standardized behavioural approach based on mindfulness - which will be delivered mainly by telemedicine and smartphone applications . The aim of this pilot study is to assess the feasibility and the effectiveness at long-term on relevant outcomes of a specific protocol, designed to be appropriate during the emergency situation due to COVID-19 epidemic, by an approach that is alternative to current practice, particularly as far as reducing face-to-face hospital visits taking advantage of facilities offered by new technologies, besides including innovative and emerging treatment choices, namely a behavioural approach base on mindfulness