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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.