Status:
UNKNOWN
ACT Therapy for HF Migraine
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Migraine Without Aura
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Background and significance. Patients with Migraine without Aura at high frequency of attacks (9/14 episode per month) are particularly exposed to the risk of medication overuse and chronification of ...
Eligibility Criteria
Inclusion
- Age 18-65 years;
- Diagnosis of High Frequency Episodic Migraine without Aura according to the IHS criteria, i.e. 9-14 days with headache per month in the previous three months.
- Patients were stable in terms of pharmacological prophylaxis (for those cases in which it has been prescribed) in the preceding three months.
Exclusion
- Overuse of medications as defined by the ICHD, i.e. 15 or more NSAIDs per month, 10 or more triptans per month, 10 or more opioids, 10 or more combined compounds per month in the previous three months
- Withdrawal intervention during the 18 months preceding the inclusion in the clinical program
- Known major depression or other psychiatric condition as reported in clinical documentation
- Known epilepsy and idiopathic intracranial hypertension as reported in clinical documentation
- Psychotherapy (any approach) in the previous 18 months
- Previous experience on mindfulness or meditation approaches (lifetime)
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03461874
Start Date
March 15 2018
End Date
December 1 2022
Last Update
February 11 2021
Active Locations (1)
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1
Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit
Milan, Italy, 20133