Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Italy
- Florence · Centro Cefalee e Farmacologia ClinicaTaking people
- Florence · Fiammetta COSCINot yet recruiting
The registry text, word for word
Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients
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.
Inclusion: 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.
Exclusion: diagnosis of medication overuse headache; under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy); 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; being pregnant or lactating.