Mindfulness Therapy for Chronic Migraine

Summary

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.

Conditions

• Chronic Migraine
• Medication Overuse Headache

Interventions

BEHAVIORAL

Mindfulness

The experimental group will receive education, will be prescribed prophylaxis and will attend Mindfulness-based therapy sessions. The MINDFULNESS therapy consists in 6 weekly sessions, 45 minutes each. The main focus of the six mindfulness session will be the following: 1) introduction and meaning; 2) Focus on breath; 3) posture and body awareness; 4) meditation of sounds; 5) Guided imagery; 6) acceptance and awareness. During training, patients will be invited to close their eyes, assume a relaxed position, focus on their breathing and on the present to enhance awareness of current mind and body sensations. Patients will be trained in small groups (5-7 patients each) and guided by a specifically trained therapist. They will be educated to practice at home according to the instructions given by the therapist during the sessions.

DRUG

Prophylactic

Control group will receive education on the use of pharmacological compounds for acute treatment and on healthy lifestyle habits (e.g. adequate sleep/wake pattern, eating and hydration, physical activity, avoidance of triggers) and will be prescribed prophylactic medications. The preventive compound will be chosen on the basis of clinical profile among the following categories: neuromodulators (e.g. topiramate or valproate), antidepressant (e.g. tricyclics or SSRIs) or others, e.g. beta-blockers.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-05

Primary Completion

2023-11-20

Completion

2023-11-20

Countries

• Italy

Study Locations