Clinical trial NCT03404336: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
Keywords: migraine
chronic
well-being therapy
psychotherapy
therapy
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot study, designed as a randomized (1:1) controlled trial, comparing WBT vs a control condition. The patients will receive a baseline assessment to confirm the diagnosis of chronic migraine, then socio-demographic information, information on pharmacological/non-pharmacological treatments, on the history of medical diseases and on the psychological status will be collected as well as the number of migraine attacks per month, the duration of migraine attacks, the occurrence of migraine exclusively with menses, and the level of disability related to migraine. Thereafter, the subjects will be randomly assigned to WBT or to a control condition. The subjects will be re-assessed at the end of session 4, 8 of treatment, at 3-month and 6-month follow-ups.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: disability due to migraine
timeFrame: from baseline to 3-month follow up
measure: frequency of migraine attacks
timeFrame: from baseline to 3-month follow up
measure: duration of migraine attacks
timeFrame: from baseline to 3-month follow up
measure: intensity of migraine attacks
timeFrame: from baseline to 3-month follow up
Secondary outcomes:
measure: level of anxiety and depression
timeFrame: from baseline to 3-month follow up
measure: level of psychological well-being
timeFrame: from baseline to 3-month follow up
measure: level of psychological well-being
timeFrame: from baseline to 3-month follow up
measure: the level of euthymia
timeFrame: from baseline to 3-month follow up
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Fiammetta COSCI
city: Florence
country: Italy
facility: Centro Cefalee e Farmacologia Clinica
Study officials:
References:
citation: 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.