Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT03404336

Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy

Led by University of Florence · Updated on 2026-05-05

30

Participants Needed

2

Research Sites

430 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the literature on their efficacy is poor and showed mixed results. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. It can be implemented to empower psychological well-being. The aim of the present study is to test the efficacy of WBT in a sample of patients with chronic migraine to verify if it reduces the disability due to migraine and distress, it increases the psychological well-being as well as the level of euthymia.

CONDITIONS

Official Title

Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to participate with signed informed consent
  • Aged 18 to 65 years
  • Italian native speaker
  • Diagnosed with chronic migraine per International Classification of Headache Disorders, with unilateral pulsating moderate/severe pain aggravated by routine activities and accompanied by nausea/vomiting, light and sound sensitivity, with headaches on 15 or more days per month
  • Headache chronicity for at least 1 year with stable symptoms for at least 6 months
  • No or stable pharmacological or dietary supplement treatment for chronic migraine for at least 3 months
  • Psychotropic medication allowed if stable for at least 3 months
Not Eligible

You will not qualify if you...

  • Diagnosis of medication overuse headache
  • Presence of psychiatric disorders diagnosed by MINI International Neuropsychiatric Interview per DSM-5
  • Presence of chronic unstable medical conditions
  • Pregnant or breastfeeding
  • Receiving exogenous hormone treatment such as hormonal contraceptives or postmenopausal hormone therapy
  • Any other condition that may affect ability to follow study procedures as judged by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Fiammetta COSCI

Florence, Florence, Italy, 50135

Not Yet Recruiting

2

Centro Cefalee e Farmacologia Clinica

Florence, Italy, Italy

Actively Recruiting

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Research Team

F

Fiammetta COSCI, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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