An interventional study of Well-Being Therapy and Control condition in Chronic Migraine, sponsored by University of Florence. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Florence · Not applicable, Interventional, and Treatment
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.
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. The psychological interventions tested up to now are the Acceptance and Commitment Therapy and the Mindfulness. Well-Being Therapy (WBT) is a brief psychotherapy which has been manualized in 2016 and has shown efficacy in randomized clinical trials. It showed to be effective in decreasing the relapse rates of depression in adults, it showed to be effective in generalized anxiety disorder and in cyclothymia. Thus, psychological well-being can be implemented and empowered via a specific psychotherapy and this implementation might produce a protecting effect, thus favoring prevention. The aim of the present study is to test the efficacy of WBT in a sample of patients with chronic migraine. First the efficacy of WBT will be verified in terms of disability due to migraine. Then, the efficacy of WBT will be measured in terms of psychological well-being, euthymia, and distress. For this purpose, 30 chromic migraine outpatients will be enrolled in a randomized, controlled, open clinical study.
Exclusion criteria:
WBT will be used as the only non-pharmacological therapeutic strategy and 8 sessions will be delivered every other week with a duration of 60 minutes each. The manualized WBT will be used (Fava, 2016). Thus, the initial phase will be concerned with self-observation of psychological well-being. Once the instances of well-being will be properly recognized, the patient will be encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of well-being (intermediate phase). The final part will involve cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail.
Behavioral: Well-Being Therapy
The control condition will include 8 be-weekly sessions based on Lifestyle and well-being National Institute for health and Care Excellence (NICE) guidelines (https://www.nice.org.uk/guidance/lifestyle-and-wellbeing) and on World Health Organization 12 steps to healthy eating (http://www.euro.who.int/en/health-topics/disease-prevention/nutrition/a-healthy-lifestyle). These sessions will inform participants about well-being and which lifestyles can influence it.
Other: Control condition
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.
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.
disability due to migraine
level of disability due to migraine assessed via the Migraine Disability Assessment Score (score from 0 to \>21, for total score \> 6 disability is clinically relevant)
Time frame: from baseline to 3-month follow up
frequency of migraine attacks
frequency of migraine attacks assessed via a daily self-report headache diary (higher the frequency, higher the severity of migraine)
Time frame: from baseline to 3-month follow up
duration of migraine attacks
duration of migraine attacks assessed via a daily self-report headache diary (higher the duration, higher the severity of migraine)
Time frame: from baseline to 3-month follow up
intensity of migraine attacks
intensity of migraine attacks assessed via a daily self-report headache diary (higher the intensity, higher the severity of migraine)
Time frame: from baseline to 3-month follow up
level of anxiety and depression
the level of anxiety and depression will be assessed via the Symptom Questionnaire (total score from 0 to 92, higher is the total score and worse is the symptomatology)
Time frame: from baseline to 3-month follow up
level of psychological well-being
assessed via the World Health Organization-Five Well-Being Index (WHO 5) (total score from 0 to 25, higher total score means higher quality of life)
Time frame: from baseline to 3-month follow up
level of psychological well-being
assessed via Psychological Well-Being Questionnaire (PWB) (total score from 84 to 504, higher score corresponds to higher psychological well-being)
Time frame: from baseline to 3-month follow up
the level of euthymia
the level of euthymia will be assessed via the euthymia scale (total score from 0 to 10, higher score corresponds to higher level of euthymia)
Time frame: from baseline to 3-month follow up
Plan to share: No
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University of Florence