Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Migraine
Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Migraine
Chronic Migraine and Migraine without aura at high frequency are disabling conditions also in
 adolescence age (2% of adolescents report chronic migraine) Common pharmacological treatments
 are often inadequate. It has been reported that clinical results can be improved when
 traditional therapies are combined with behavioral approaches in particular mindfulness, that
 help patients to become more conscious about their symptoms and able to manage pain without
 medication. Generally, according to standard clinical practice, young patients (12-17 yrs
 old) treated by mindfulness practice come to the hospital to practice mindfulness in small
 groups of patients for 6 weekly 45 minutes sessions. As the emergency situation due to the
 Corona-virus pandemic phenomenon in Italy, patients missed the possibility to come for the
 regular practice to the hospital: for this reason the investigators propose a small pilot
 study to enforce the use of technology for patients so that they can continue to be followed
 during their therapeutic process. This preliminary study will be conducted on 25 patients
 They will be trained to practice mindfulness daily by a standard session of 12 minutes on
 their smartphone recorded by the expert who generally manage their sessions at the hospital.
 Also a weekly video-session will be performed to evaluate the clinical condition, to practice
 guided mindfulness sessions and to encourage to use strategies for pain management . This
 modality will allow patients to continue their therapeutic process and to be followed
 regularly during the one year after treatment. Follow up sessions are planned every three
 months: these meetings at the hospital will be face-to-face with every patient to check the
 clinical condition by the patient's diary. Last follow up one year after treatment.
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
Inclusion Criteria:

 -  clinical diagnosis of Chronic Migraine or High Frequency Migraine without aura

 -  written informed consent

 Exclusion Criteria:

 -  co-existent severe medical or psychiatric illnesses, documented by specific previous
 diagnoses

 -  seizures

 -  use of opioids

 -  participation to other projects with behavioral approaches in the last