Treatment of chronic migraine with Well-Being Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy of Well-Being Therapy (WBT) in treating chronic migraine in outpatients. It aims to determine if WBT can reduce migraine-related disability and distress while enhancing psychological well-being and euthymia. The study will enroll 30 participants who meet specific criteria and will compare the effects of WBT against a control condition. Participants will be assessed for changes in their migraine symptoms and overall mental health.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centro Cefalee e Farmacologia Clinica
  Florence, Italy, Italy Recruiting
• Fiammetta COSCI
  Florence, Florence, Italy Not yet recruiting

Study contacts

• Study coordinator: Fiammetta COSCI, Prof.
• Email: fiammetta.cosci@unifi.it
• Phone: 0552755066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.