Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control T… (NCT03404336) | Clinical Trial Compass
RecruitingNot Applicable
Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
Italy30 participantsStarted 2018-10-01
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✕. 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;