Mindfulness Therapy for Chronic Migraine

PHASE4CompletedINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

November 5, 2018

Primary Completion Date

November 20, 2023

Study Completion Date

November 20, 2023

Conditions
Chronic MigraineMedication 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.

Trial Locations (1)

20133

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit, Milan

All Listed Sponsors
lead

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

OTHER

NCT03671681 - Mindfulness Therapy for Chronic Migraine | Biotech Hunter | Biotech Hunter