Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
Well-Being Therapy: Session 1: identifying and setting episodes of wellbeing into situational context. Session 2: identifying interfering thoughts and behaviors. Session 3: illustrating autonomy, reflecting and practicing it. Session 4: illustrating environmental mastery, reflecting and practicing it. Session 5: illustrating positive relations with others, reflecting and practicing it. Session 6: illustrating personal growth, reflecting and practicing it. Session 7: illustrating self-acceptance, reflecting and practicing it. Session 8: illustrating purpose in life, reflecting and practicing it.
Control condition: Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drugs misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed.
Study summary
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.
Eligibility
Primary outcome measure(s)
- disability due to migraine — from baseline to 3-month follow up
level of disability due to migraine assessed via the Migraine Disability Assessment Score (score from 0 to \>21, for total score \> 6 disability is clinically relevant) - frequency of migraine attacks — from baseline to 3-month follow up
frequency of migraine attacks assessed via a daily self-report headache diary (higher the frequency, higher the severity of migraine) - duration of migraine attacks — from baseline to 3-month follow up
duration of migraine attacks assessed via a daily self-report headache diary (higher the duration, higher the severity of migraine) - intensity of migraine attacks — from baseline to 3-month follow up
intensity of migraine attacks assessed via a daily self-report headache diary (higher the intensity, higher the severity of migraine)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Fiammetta COSCI | Florence | Florence | Not Yet Recruiting |
| Centro Cefalee e Farmacologia Clinica | Florence | Italy | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03404336 on ClinicalTrials.gov ↗ ← All trials in Italy