Chronic MigraineNCT03404336
Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
A study testing Well-Being Therapy in people with Chronic Migraine, run by University of Florence at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Well-Being Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Oct 2018to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
Fiammetta COSCI
Florence, Florence, 50135
Fiammetta COSCI, MD, PhD, 0552755066 ext. 0039, fiammetta.cosci@unifi.it
- Recruiting
Centro Cefalee e Farmacologia Clinica
Florence, Italy
Francesco De Cesaris, MD
About this study
Official title: Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients
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.
Read the 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.
- Conditions
- Chronic Migraine
- Being tested
- Well-Being Therapy, Control condition
- Keywords
- migraine, chronic, well-being therapy, psychotherapy, therapy
- Medical subject headings
- Migraine Disorders, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being TherapyBehavioural
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 conditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: from baseline to 3-month follow up
Secondary outcomes (4)
level of anxiety and depression
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)
Measured: from baseline to 3-month follow up
level of psychological well-being
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)
Measured: from baseline to 3-month follow up
level of psychological well-being
assessed via Psychological Well-Being Questionnaire (PWB) (total score from 84 to 504, higher score corresponds to higher psychological well-being)
Measured: from baseline to 3-month follow up
the level of euthymia
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)
Measured: from baseline to 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Oct 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiammetta Cosci, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404336
- Sponsor's protocol ID
- WBT in MIG
- Status last verified
- Apr 2026
- First submitted
- 31 Dec 2017
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30326932
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial to Evaluate the Efficacy of Well-Being Therapy vs a Control Condition in Chronic Migraine Patients
- ClinicalTrials.gov ID
- NCT03404336
- Acronym / sponsor ID
- WBT in MIG
- Conditions
- Chronic Migraine
- Keywords
- migraine, chronic, well-being therapy, psychotherapy, therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Well-being therapy | Experimental | Behavioral: Well-Being TherapyWBT 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. |
| Control condition | Placebo comparator | Other: Control conditionThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Well-Being TherapySession 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. | Behavioural | Well-being therapy |
| Control conditionSession 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. | Other | Control condition |
Primary outcome
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)
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)
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)
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)
4 secondary outcomes
level of anxiety and depression
Time frame: from baseline to 3-month follow up
level of psychological well-being
Time frame: from baseline to 3-month follow up
level of psychological well-being
Time frame: from baseline to 3-month follow up
the level of euthymia
Time frame: from baseline to 3-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 30326932Mansueto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-Being Therapy in people with Chronic Migraine, run by University of Florence at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiammetta COSCI, Prof. (0552755066 ext. 0039, fiammetta.cosci@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disability due to migraine (time frame: from baseline to 3-month follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.