NCT03404336 Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
| NCT ID | NCT03404336 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florence |
| Condition | Chronic Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-10-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2018-10-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: 1. able and interested in participating to the present research project, as proved by signed Informed consent; 2. 18-65 years of age; 3. Italian mother tongue; 4. diagnosis of chronic migraine according to the International Classification of Headache Disorders. Thus, presenting specific features (i.e., unilateral and pulsating pain of moderate or severe intensity, which is aggravated or precipitated by routine physical activities and is combined with nausea and/or vomiting, photophobia, and phonophobia) and migraine headache on ≥ 15 days per month; 5. headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months; 6. no pharmacological therapy or dietary supplements use for chronic migraine OR pharmacological therapy/dietary supplement use for chronic migraine stable since at least 3 months; 7. psychotropic medication allowed only if stable since at least three months. Exclusion criteria: 1. diagnosis of medication overuse headache; 2. co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders (DSM) 5th edition as diagnosed via the MINI International Neuropsychiatric Interview; 3. co-occurrence of chronic unstable medical conditions; 4. being pregnant or lactating; 5. under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy); 6. any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03404336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03404336 currently recruiting?
Yes, NCT03404336 is actively recruiting participants. Contact the research team at fiammetta.cosci@unifi.it for enrollment information.
Where is the NCT03404336 trial being conducted?
This trial is being conducted at Florence, Italy, Florence, Italy.
Who is sponsoring the NCT03404336 clinical trial?
NCT03404336 is sponsored by University of Florence. The trial plans to enroll 30 participants.
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