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Effectiveness and Acceptability of MINDFULNESS by Smartphone, for Patients With Chronic Migraine and Medication Overuse (ChroMig-Smart)

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ClinicalTrials.gov Identifier: NCT04389372
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Brief 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

Condition or disease Intervention/treatment Phase
Migraine Headache Behavioral: Mindfulness Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Effectiveness of Mindfulness Program by Smartphone for Patients With Chronic Migraine and Medication Overuse During Covid-19 Emergency
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arm Intervention/treatment
Experimental: Mindfulness by Smartphone
mindfulness therapy by smart phone
Behavioral: Mindfulness
Mindfulness by smartphone combined to video calls for clinical evaluation in patients with chronic migraine and medication overuse after withdrawal program




Primary Outcome Measures :
  1. Efficacy of Mindfullness by Smartphone [ Time Frame: at 6 months and 12 months follow-up compared with baseline (Headache Daily Diary) ]
    Changes in migraine /days per month and medication intake/month (decrease of at least 50% in at least 50% of CM-MO patients)


Secondary Outcome Measures :
  1. Change of Disability Score [ Time Frame: 6months - 12months ]
    Changes in disability, impact Migraine Disability Assessment Score (MIDAS questionnaire) minimum score 0-maximum score 270 HIGHER SCORES worse outcome (they indicate more disability)

  2. Change in Quality of life [ Time Frame: 6months - 12 months ]
    Changes in Headache Impact Test (HIT-6) minimum score 36- maximum score 78 HIGHER SCORES worse outcome (they indicate more impact)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389372


Contacts
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Contact: Licia Grazzi, MD 022394 ext 2366 licia.grazzi@istituto-besta.it
Contact: Renato Mantegazza, MD 022394 ext 2321 crc@istituto-besta.it

Locations
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Italy
UOC Neurologia 3 Recruiting
Milano, Italy, 20133
Contact: Licia Grazzi, MD    022394 ext 2366    licia.grazzi@istituto-besta.it   
Contact: Renato Mantegazza, MD    022394 ext 2321    crc@istituto-besta.it   
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
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Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT04389372    
Other Study ID Numbers: Chro-Mig-Smart
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations