The aim is to compare the effectiveness of a behavioral treatment, the Acceptance and
Commitment Therapy, provided as an add-on to the prophylactic treatment (treatment as
usual-TaU) against TaU only on the reduction of monthly headaches frequency over 12 months in
a sample of patients with high-frequency migraine without aura (i.e. reporting 9-14 days with
headache per month in the previous three months).
ACT will be provided in small groups (5-7 patients each) by specifically trained therapists.
The ACT consists in 6 weekly sessions, 90 minutes each, and 2 supplementary "booster"
sessions, at two and four weeks after the conclusion of the weekly session. The main focus of
the six ACT session will be the following: 1) Creative helplessness: the problem of control;
2) Identifying values: introduction to Mindfulness; 3) Actions guided by values: working with
thought; 4) Working with Acceptance and Willingness; 5) Committed Actions: self-as-context;
6) Integration: working with obstacles - wrap-up. The booster session starts with a
mindfulness exercise, followed by a review of the contents covered across the ACT program.
TaU will consist of 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 and
limited to Topiramate, Propanolol, Amytriptiline or Calcium channel blockers.
The study will be a Phase II Trial; randomized, Open-Label; Multicenter study. Patients will
be randomized 1:1 to the two groups: 64 patients (32 per group) will be enrolled to detect an
absolute difference of at least 2 migraine days/month in the experimental group (assuming
alfa 5%, power 95%, up to 15% loss to follow-up).
Phase:
N/A
Details
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta