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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Centro Cefalee e Farmacologia Clinica
RECRUITING
Florence
Fiammetta COSCI
NOT_YET_RECRUITING
Florence
Contact Information
Primary
Fiammetta COSCI, Prof.
fiammetta.cosci@unifi.it
0552755066
Time Frame
Start Date: 2018-10-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 30
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Florence

This content was sourced from clinicaltrials.gov

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