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NCT Number: NCT03404336

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. disability due to migraine

    Time frame: 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)

  2. frequency of migraine attacks

    Time frame: 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)

  3. duration of migraine attacks

    Time frame: 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)

  4. intensity of migraine attacks

    Time frame: 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)

Secondary outcomes

  1. level of anxiety and depression

    Time frame: 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)

  2. level of psychological well-being

    Time frame: from baseline to 3-month follow up

    assessed via the World Health Organization-Five Well-Being Index (WHO 5) (total score from 0 to 25, higher total score means higher quality of life)

  3. level of psychological well-being

    Time frame: 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)

  4. the level of euthymia

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Fiammetta COSCI, Prof.

CONTACT

[email protected]

0552755066 ext. 0039

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2018
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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