Study on 30 Outpatients with Chronic Migraine Treated with Well-Being Therapy or with a Control Therapy

Launched by UNIVERSITY OF FLORENCE · Jan 18, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a type of therapy called Well-Being Therapy (WBT) to see if it can help people with chronic migraines. Chronic migraines can be very disabling and often don’t respond well to traditional treatments. WBT is a short form of psychotherapy that aims to improve psychological well-being and reduce distress. The researchers want to find out if WBT can help reduce the problems caused by migraines and improve overall mental health.

To participate in this study, individuals need to be between 18 and 65 years old, speak Italian, and have a diagnosis of chronic migraine, which means they experience headaches on 15 or more days each month. They should have had chronic migraines for at least a year, and their symptoms should have been stable for the last six months. Participants will receive either WBT or a control therapy and will be monitored throughout the study to see how effective the therapy is. It’s important to note that certain medical conditions and medications may disqualify some individuals from joining the study.

Gender

ALL

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.