The aim is to assess the efficacy of adding on a Mindfulness-based therapy to pharmacological
prophylaxis (experimental group: pharmacological prophylaxis + Mindfulness) against
pharmacological prophylaxis only (control group) on the reduction of monthly headaches
frequency (primary endpoint), symptomatic medications intake, inflammatory pattern,
depression, anxiety, cutaneous allodynia, improving disability and quality of life (secondary
endpoints). Moreover, other aims are to assess whether adding on Mindfulness-based therapy is
also associated to a superior improvement of neuroimaging pattern among patients prescribed
neuromodulators or antidepressants and to assess the cost-efficacy of adding on a
Mindfulness-based therapy to pharmacological prophylaxis. Mindfulness will be provided in
small groups (5-7 patients each) by specifically trained therapists. The treatment consists
in six 45 minutes weekly sessions in which one will work on meditation, acceptance and
awareness. The program of control group will consist in education of patients, followed by
pharmacological prophylaxis. Prophylaxis is prescribed based on patients' profile, such as
previous failures, contraindications and so on by a neurologist with expertise in headache
treatments. We expect that adding-on Mindfulness will determine a wider reduction of
headaches frequency and improvement of secondary endpoints, and that disease cost reduction
will support the cost-efficacy of Mindfulness. The study will be a Phase III; randomized,
Open-Label; Monocentric study. Patients will be enrolled to detect a 20% difference between
the two groups on the primary outcome (50% or more of headache reduction by 12 months). For
each medication type and research arm 20 patients will be selected: thus 80 patients will be
enrolled for neuroradiological investigation.
Phase:
N/A
Details
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta