RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. able and interested in participating to the present research project, as proved by signed willing to sign a consent form; 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

Well-Being Therapy

Session 1: identifying and setting episodes of wellbeing into situational context. Session 2: identifying interfering thoughts and behaviors. Session 3: illustrating autonomy, reflecting and practicing it. Session 4: illustrating environmental mastery, reflecting and practicing it. Session 5: illustrating positive relations with others, reflecting and practicing it. Session 6: illustrating personal growth, reflecting and practicing it. Session 7: illustrating self-acceptance, reflecting and practicing it. Session 8: illustrating purpose in life, reflecting and practicing it.

OTHER

Control condition

Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drugs misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed.

Locations (2)

Fiammetta COSCI

Florence, Florence, Italy

Centro Cefalee e Farmacologia Clinica

Florence, Italy, Italy