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

Not Applicable

Recruiting

• Conditions: Chronic Migraine
• Interventions: Other: Control condition; Behavioral: Well-Being Therapy

• Registration Number: NCT03404336
• Lead Sponsor: University of Florence

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.

Study Timeline

• Study First Submitted: 2017-12-31
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-19
• Study Start: 2018-10-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control condition	Control condition	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.
Well-being therapy	Well-Being Therapy	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.

Primary Outcome Measures

Name	Time	Method
duration of migraine attacks	from baseline to 3-month follow up	duration of migraine attacks assessed via a daily self-report headache diary (higher the duration, higher the severity of migraine)
intensity of migraine attacks	from baseline to 3-month follow up	intensity of migraine attacks assessed via a daily self-report headache diary (higher the intensity, higher the severity of migraine)
disability due to migraine	from baseline to 3-month follow up	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)
frequency of migraine attacks	from baseline to 3-month follow up	frequency of migraine attacks assessed via a daily self-report headache diary (higher the frequency, higher the severity of migraine)

Secondary Outcome Measures

Name	Time	Method
the level of euthymia	from baseline to 3-month follow up	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)
level of anxiety and depression	from baseline to 3-month follow up	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)
level of psychological well-being	from baseline to 3-month follow up	assessed via Psychological Well-Being Questionnaire (PWB) (total score from 84 to 504, higher score corresponds to higher psychological well-being)

Trial Locations

Locations (2)

Fiammetta COSCI; 🇮🇹 Florence, Italy

Centro Cefalee e Farmacologia Clinica; 🇮🇹 Florence, Italy