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

NCT03404336 | Recruiting

• 1 other identifier: WBT in MIG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Migraine

Keywords

migraine; chronic; well-being therapy; psychotherapy; therapy

Outcome Measures

Primary Outcomes (4)

• 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)

  from baseline to 3-month follow up

• frequency of migraine attacks

  frequency of migraine attacks assessed via a daily self-report headache diary (higher the frequency, higher the severity of migraine)

  from baseline to 3-month follow up

• duration of migraine attacks

  duration of migraine attacks assessed via a daily self-report headache diary (higher the duration, higher the severity of migraine)

  from baseline to 3-month follow up

• intensity of migraine attacks

  intensity of migraine attacks assessed via a daily self-report headache diary (higher the intensity, higher the severity of migraine)

  from baseline to 3-month follow up

Secondary Outcomes (4)

• level of anxiety and depression

  from baseline to 3-month follow up

• level of psychological well-being

  from baseline to 3-month follow up

• level of psychological well-being

  from baseline to 3-month follow up

• the level of euthymia

  from baseline to 3-month follow up

Study Arms (2)

Well-being therapy

EXPERIMENTAL

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.

Behavioral: Well-Being Therapy

Control condition

PLACEBO COMPARATOR

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.

Other: Control condition

Interventions

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.

Well-being therapy

Control condition OTHER

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.

Control condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able and interested in participating to the present research project, as proved by signed Informed consent;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florence: lead

Study Sites (2)

Fiammetta COSCI

Florence, Florence, 50135, Italy

NOT YET RECRUITING

Centro Cefalee e Farmacologia Clinica

Florence, Italy, Italy

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Fiammetta COSCI, Prof.

CONTACT

0552755066; fiammetta.cosci@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed if they will receive the WBT or the control condition. Of course, after the end of the study they will receive this information and they will be told why they were blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Clinical Psychology

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: January 19, 2018
• Study Start: October 1, 2018
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)