Can talk therapy tame chronic migraine? small trial aims to find out

NCT ID NCT03404336

Symptom relief Sponsor: University of Florence Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether Well-Being Therapy, a short psychotherapy focused on building positive mental health, can reduce disability and distress in 30 adults with chronic migraine. Participants will receive either the therapy or a control condition. The goal is to see if this non-drug approach can improve quality of life and reduce migraine burden.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Well-Being Therapy (a brief psychotherapy)
What this could lead to: If it works, this could offer a non-drug option to ease migraine-related disability and improve psychological well-being.
What could go wrong: This is a very small pilot study (30 people) with no blinding, so results may not be reliable or apply to everyone. The therapy may not reduce migraine attacks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. able and interested in participating to the present research project, as proved by signed Informed consent; 2. 18-65 years of age; 3. Italian mother tongue; 4. 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; 5. headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months; 6. 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; 7. psychotropic medication allowed only if stable since at least three months. Exclusion criteria: 1. diagnosis of medication overuse headache; 2. 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; 3. co-occurrence of chronic unstable medical conditions; 4. being pregnant or lactating; 5. under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy); 6. any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can talk therapy tame chronic migraine? small trial aims to find out

What the study statuses mean