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

ConditionChronic Migraine

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Florence

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

diagnosis of medication overuse headache;

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;

being pregnant or lactating;

Trial design

Design model

Parallel

Treatments tested in this trial

Well-Being Therapy
Behavioral
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.
Control condition
Other intervention
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Well-being therapyExperimental treatment 1 intervention

Group B: Control conditionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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