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
Behavioral: Mindfulness
Patients 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.
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
Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit
Milano, Italy
Investigator: Licia Grazzi, MD
Contact: +39022394
licia.grazzi@istituto-besta.it
Investigator: Licia Grazzi, MD