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

F

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Status

Unknown

Conditions

Migraine Headache

Treatments

Behavioral: Mindfulness

Study type

Interventional

Funder types

Other

Identifiers

NCT04389372
Chro-Mig-Smart

Details and patient eligibility

About

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

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:+

  • Years age >18 yrs
  • clinical diagnosis of Chronic Migraine with medication Overuse
  • withdrawal treatment at the Besta institute
  • written informed consent

Exclusion Criteria:

none

Trial design

50 participants in 1 patient group

Mindfulness by Smartphone
Experimental group
Description:
mindfulness therapy by smart phone
Treatment:
Behavioral: Mindfulness

Trial contacts and locations

0

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Central trial contact

Renato Mantegazza, MD; Licia Grazzi, MD

Data sourced from clinicaltrials.gov

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