Study: NCT03461874

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Education of patients
Description: During withdrawal treatment, patients are given recommendations on the approach to the use of drugs for acute treatment of migraine headache and on lifestyle issues. With regard to drugs, patients will be encouraged to restrict use of acute medications to headaches with severe pain; i.e., those rated as 8 or greater on a 0-10 (no pain - pain as bad as it could be). In these instances, patients will be instructed to take Eletriptan (40 mg) and/or Almotriptan (12.5 mg) as the first-line treatment, indomethacin (50 mg) as the second line, and will be specifically urged to avoid opioids. With regard to healthy lifestyle issues, patients will be encouraged to engage in moderate physical activity (i.e., 45 minutes twice per week of aerobic exercise), remain well hydrated, consume 3 meals per day, and maintain a regular sleep/wake pattern with at least 7-8 hours of sleep per night.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Education of patients
Description: During withdrawal treatment, patients are given recommendations on the approach to the use of drugs for acute treatment of migraine headache and on lifestyle issues. With regard to drugs, patients will be encouraged to restrict use of acute medications to headaches with severe pain; i.e., those rated as 8 or greater on a 0-10 (no pain - pain as bad as it could be). In these instances, patients will be instructed to take Eletriptan (40 mg) and/or Almotriptan (12.5 mg) as the first-line treatment, indomethacin (50 mg) as the second line, and will be specifically urged to avoid opioids. With regard to healthy lifestyle issues, patients will be encouraged to engage in moderate physical activity (i.e., 45 minutes twice per week of aerobic exercise), remain well hydrated, consume 3 meals per day, and maintain a regular sleep/wake pattern with at least 7-8 hours of sleep per night.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ACT
Description: 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) Indentifying 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.~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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pharmacological prophylaxis
Description: Pharmacological prophylaxis will be prescribed based on patients' profile (e.g. previous failures or contraindications), and limited to Topiramate, Propanolol, Amytriptiline or Flunarizine. Doses will depend on patients' features, and the doses herein reported are to be intended as approximate ones: Topiramate at the dose of 50mg/day; Propanolol at the dose of 20mg/day; Amytriptiline at the dose of 10mg/day; Flunarizine at the dose of 5mg/day.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pharmacological prophylaxis
Description: Pharmacological prophylaxis will be prescribed based on patients' profile (e.g. previous failures or contraindications), and limited to Topiramate, Propanolol, Amytriptiline or Flunarizine. Doses will depend on patients' features, and the doses herein reported are to be intended as approximate ones: Topiramate at the dose of 50mg/day; Propanolol at the dose of 20mg/day; Amytriptiline at the dose of 10mg/day; Flunarizine at the dose of 5mg/day.