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NCT04604977Completed

Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Migraine

Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Chronic Migraine and High Frequency Migraine Without Aura After the Covid-19 Emergency

Source: ClinicalTrials.gov · Last updated 23 Jan 2025

Brief summary (registry, in English)

Chronic Migraine and Migraine without aura at high frequency are disabling conditions also in adolescence age (2% of adolescents report chronic migraine) Common pharmacological treatments are often inadequate. It has been reported that clinical results can be improved when 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. Generally, according to standard clinical practice, young patients (12-17 yrs old) treated by mindfulness practice come to the hospital to practice mindfulness in small groups of patients for 6 weekly 45 minutes sessions. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients missed the possibility to come for the regular practice to the hospital: for this reason the investigators propose a small pilot study to enforce the use of technology for patients so that they can continue to be followed during their therapeutic process. This preliminary study will be conducted on 25 patients They will be trained to 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-session will be performed to evaluate the clinical condition, to practice guided mindfulness sessions and to encourage to use strategies for pain management . This modality will allow patients to continue their therapeutic process and to be followed regularly during the one year after treatment. Follow up sessions are planned every three months: these meetings at the hospital will be face-to-face with every patient to check the clinical condition by the patient's diary. Last follow up one year after treatment.

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
20 Oct 2020
Start date
15 Dec 2023
Primary completion date
15 Dec 2023
Lead sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Diseases
Migraine
NCT number
NCT04604977

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 15 Dec 2023 to the primary completion date, 15 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • co-existent severe medical or psychiatric illnesses, documented by specific previous diagnoses

Other illness

  • seizures

Other

  • use of opioids
  • participation to other projects with behavioral approaches in the last

Who the study is looking for

  • clinical diagnosis of Chronic Migraine or High Frequency Migraine without aura
  • written informed consent

Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.