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

Migraine Headache Clinical Trial

— ChroMig-Smart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389372
• Other study ID #: Chro-Mig-Smart
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: December 2021

Study information

• Verified date: May 2020
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: Licia Grazzi, MD
• Phone: 022394
• Email: licia.grazzi[@]istituto-besta.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:+

1. Years age >18 yrs

2. clinical diagnosis of Chronic Migraine with medication Overuse

3. withdrawal treatment at the Besta institute

4. written informed consent

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Behavioral:
• Mindfulness
Mindfulness by smartphone combined to video calls for clinical evaluation in patients with chronic migraine and medication overuse after withdrawal program

Locations

Country	Name	City	State
Italy	UOC Neurologia 3	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Mindfullness by Smartphone	Changes in migraine /days per month and medication intake/month (decrease of at least 50% in at least 50% of CM-MO patients)	at 6 months and 12 months follow-up compared with baseline (Headache Daily Diary)
Secondary	Change of Disability Score	Changes in disability, impact Migraine Disability Assessment Score (MIDAS questionnaire) minimum score 0-maximum score 270 HIGHER SCORES worse outcome (they indicate more disability)	6months - 12months
Secondary	Change in Quality of life	Changes in Headache Impact Test (HIT-6) minimum score 36- maximum score 78 HIGHER SCORES worse outcome (they indicate more impact)	6months - 12 months