NCT03671681CompletedPhase 4
Mindfulness Therapy for Chronic Migraine
A Randomized Clinical Trial on the Efficacy and Cost-efficacy of Adding on a Mindfulness-based Therapy to Standard Medical Prophylaxis in the Treatment of Patients With Chronic Migraine Associated to Medication Overuse Following Structured Withdrawal: the Mind-CM Study
Source: ClinicalTrials.gov · Last updated 23 Jan 2025
Brief summary (registry, in English)
The aim is to assess the efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis (experimental group: pharmacological prophylaxis + Mindfulness) against pharmacological prophylaxis only (control group) on the reduction of monthly headaches frequency (primary endpoint), symptomatic medications intake, inflammatory pattern, depression, anxiety, cutaneous allodynia, improving disability and quality of life (secondary endpoints). Moreover, other aims are to assess whether adding on Mindfulness-based therapy is also associated to a superior improvement of neuroimaging pattern among patients prescribed neuromodulators or antidepressants and to assess the cost-efficacy of adding on a Mindfulness-based therapy to pharmacological prophylaxis. Mindfulness will be provided in small groups (5-7 patients each) by specifically trained therapists. The treatment consists in six 45 minutes weekly sessions in which one will work on meditation, acceptance and awareness. The program of control group will consist in education of patients, followed by pharmacological prophylaxis. Prophylaxis is prescribed based on patients' profile, such as previous failures, contraindications and so on by a neurologist with expertise in headache treatments. We expect that adding-on Mindfulness will determine a wider reduction of headaches frequency and improvement of secondary endpoints, and that disease cost reduction will support the cost-efficacy of Mindfulness. The study will be a Phase III; randomized, Open-Label; Monocentric study. Patients will be enrolled to detect a 20% difference between the two groups on the primary outcome (50% or more of headache reduction by 12 months). For each medication type and research arm 20 patients will be selected: thus 80 patients will be enrolled for neuroradiological investigation.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 177 (actual)
- First submitted
- 13 Sept 2018
- Start date
- 5 Nov 2018
- Primary completion date
- 20 Nov 2023
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Diseases
- Migraine
- NCT number
- NCT03671681
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 177
- From 5 Nov 2018 to the primary completion date, 20 Nov 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
- submitted to withdrawal from MO at least twice in the previous two years;
- attended any mindfulness-based therapy
Other illness
- psychiatric comorbidities of psychotic area;
- comorbidity with secondary headaches (e.g. idiopathic intracranial hypertension);
Other
- pregnancy;
Who the study is looking for
- Chronic Migraine (migraine headaches on ≥15 days of migraine headache per month, for three consecutive months) associated to Medication overuse (Regular intake for \>3 months of analgesics on \>=15 days/month or of triptans, ergotamine, NSAID, opioids or multiple drugs on \>=10 days/month). Diagnoses are made according to the third version of the International Classification of Headache Disorders (code 1.3-Chronic Migraine; code 8.2-Medication Overuse Headache).
Age in the registry: 18 years to 65 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.