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

Official title

Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients

Overview

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.

Detailed description

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.

Interventions

• 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 prac
• 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 w

Primary outcome measures

• disability due to migraine [Time frame: from baseline to 3-month follow up]
• frequency of migraine attacks [Time frame: from baseline to 3-month follow up]
• duration of migraine attacks [Time frame: from baseline to 3-month follow up]
• intensity of migraine attacks [Time frame: from baseline to 3-month follow up]

Secondary outcome measures (4)

• level of anxiety and depression [Time frame: from baseline to 3-month follow up]
• level of psychological well-being [Time frame: from baseline to 3-month follow up]
• level of psychological well-being [Time frame: from baseline to 3-month follow up]
• the level of euthymia [Time frame: from baseline to 3-month follow up]

Eligibility criteria

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.

Exclusion criteria

• 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;
• under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy);
• any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 2 centers

• Fiammetta COSCI — Florence
• Centro Cefalee e Farmacologia Clinica — Florence

Publications

• Mansueto G, De Cesaris F, Geppetti P, Cosci F. Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial. Trials. 2018 Oct 16;19(1):561. doi: 10.1186/s13063-018-2944-5. PMID 30326932

Identifiers

NCT: NCT03404336 · WBT in MIG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗