NCT03404336Recruiting
Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 31 Dec 2017
- Start date
- 1 Oct 2018
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- University of Florence
- Diseases
- Migraine
- NCT number
- NCT03404336
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Oct 2018 to the primary completion date, 30 Dec 2026
- 2 sites 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
- diagnosis of medication overuse headache;
- under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy);
Other illness
- 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;
- co-occurrence of chronic unstable medical conditions;
- any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
Other
- being pregnant or lactating;
Who the study is looking for
- able and interested in participating to the present research project, as proved by signed Informed consent;
- 18-65 years of age;
- Italian mother tongue;
- 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;
- headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months;
- 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;
- psychotropic medication allowed only if stable since at least three months.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Cefalee e Farmacologia Clinica Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Fiammetta COSCI Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.