NCT04389372

Effectiveness and Acceptability of MINDFULNESS by Smartphone, for Patients with Chronic Migraine and Medication Overuse

Feasibility and Effectiveness of Mindfulness Program by Smartphone for Patients with Chronic Migraine and Medication Overuse During Covid-19 Emergency

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Chronic Migraine is a disabling condition that affects the 2% of migraine population. It is often associated with medication overuse that makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse but it is also confirmed that patients have to be carefully followed in the last period after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. It has been also reported how the clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. Generally patients after withdrawal follow a specific prophylaxis for migraine, but also come weekly to the hospital for practicing mindfulness for 6 sessionsAs the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients will miss the possibility to come for the regular practice to the hospital: for this reason the investigator propose a small pilot study to enforce the use of technology for our patients so that they can continue to be followed in their therapeutic process. This preliminary study will be conducted on 25 patients that have been submitted to a withdrawal according to the standard procedure at our hospital and they will practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital and also a weekly video-call to evaluate the clinical condition and to encourage to use strategies for pain management. This modality will allow the patients to continue their therapeutic process and to be followed regularly during the one year after withdrawal

Detailed description

Background and significance Chronic Migraine is a disabling condition that affects the 2% of migraine population. It is often associated with medication overuse that makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse. Also, patients need to be carefully followed after withdrawal to avoid relapses in overuse and to improve the clinical benefit. It has been also reported that the clinical results can be improved if traditional therapies are combined with behavioral approaches in particular mindfulness, that help patients to become more conscious about their symptoms and able to manage pain without medication. This preliminary study will be performed because the emergency for Covid-19 with the restrictions imposed will not allow patients. The literature of the last decades promote the use of smart phone or telemedicine for clinical and therapeutic application with encouraging results. Twenty five patients that have been submitted to a withdrawal according to the standard procedure at our hospital will practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital. Also a weekly video-call to evaluate the clinical condition and to encourage to use strategies for pain management will be scheduled. This modality will allow the patients to continue their therapeutic process and to be followed regularly during the one year after withdrawal

Conditions

• Migraine Headache

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness	Mindfulness by smartphone combined to video calls for clinical evaluation in patients with chronic migraine and medication overuse after withdrawal program

Timeline

• Start date: 2021-12-15
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2020-05-15
• Last updated: 2025-01-23

Locations

1 site across 1 country: Italy