Treatment of chronic migraine with Well-Being Therapy

Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients

This study is testing if Well-Being Therapy can help people with chronic migraines feel better and improve their mental health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Florence (Academic / other)
• Locations: 2 sites (Florence, Florence and 1 other locations)
• Trial ID: NCT03404336 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Italian-speaking adults aged 18-65 with a diagnosis of chronic migraine experiencing headaches on 15 or more days per month.

Not a fit: Patients who are currently undergoing pharmacological therapy for chronic migraine or have unstable headache patterns may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a non-pharmacological option for patients suffering from chronic migraine, potentially improving their quality of life.

How similar studies have performed: While previous studies have explored psychological interventions for migraines, the specific application of Well-Being Therapy in this context is relatively novel.

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.

Where this trial is running

Florence, Florence and 1 other locations

• Fiammetta COSCI — Florence, Florence, Italy (Not_yet_recruiting)
• Centro Cefalee e Farmacologia Clinica — Florence, Italy, Italy (Recruiting)

Study contacts

• Study coordinator: Fiammetta COSCI, Prof.

Conditions Chronic Migraine; migraine; chronic; well-being therapy; psychotherapy; therapy