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

NCT04389372 | Completed Phase 4

• 1 other identifier: Chro-Mig-Smart
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of Disability Score

  6months - 12months

• Change in Quality of life

  6months - 12 months

Study Arms (1)

Mindfulness by Smartphone

EXPERIMENTAL

mindfulness therapy by smart phone

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

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

Mindfulness by Smartphone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

UOC Neurologia 3

Milan, Milano, 20133, Italy

Location

Related Publications (1)

• Rizzoli PB, Grazzi L. Adaptation of the management of chronic migraine patients with medication overuse to the suspension of treatment protocols during the COVID-19 pandemic: Lessons from a tertiary headache center in Milan-6-month results. Headache. 2021 Jun;61(6):961-962. doi: 10.1111/head.14140. Epub 2021 Jun 21. No abstract available.

  PMID: 34153116 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 15, 2020
• Study Start: December 15, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

IT (1)