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Mind over migraine: ACT therapy shows promise in cutting headache days

NCT ID NCT03461874

Symptom relief Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding acceptance and commitment therapy (ACT) to standard migraine treatment could reduce monthly headache days in people with high-frequency episodic migraine (9-14 headache days per month). Sixty-four adults were randomly assigned to either standard care alone or standard care plus six weekly ACT sessions and two booster sessions. The goal was to see if ACT could help lower migraine frequency over 12 months.

What this could mean

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

Active substance
acceptance and commitment therapy (ACT)
What this could lead to
If it works, this could offer a drug-free way to reduce migraine frequency when added to standard treatment.
What could go wrong
This is a small, early-phase trial with only 64 participants, so results may not apply to everyone. The therapy requires time and commitment, and benefits may vary.

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

64 people

The number who actually took part.

Started

Mar 2018

Finished

Dec 2022

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. Age 18-65 years; 2. Diagnosis of High Frequency Episodic Migraine without Aura according to the IHS criteria, i.e. 9-14 days with headache per month in the previous three months. 3. Patients were stable in terms of pharmacological prophylaxis (for those cases in which it has been prescribed) in the preceding three months. Exclusion Criteria: 1. Overuse of medications as defined by the ICHD, i.e. 15 or more NSAIDs per month, 10 or more triptans per month, 10 or more opioids, 10 or more combined compounds per month in the previous three months 2. Withdrawal intervention during the 18 months preceding the inclusion in the clinical program 3. Known major depression or other psychiatric condition as reported in clinical documentation 4. Known epilepsy and idiopathic intracranial hypertension as reported in clinical documentation 5. Psychotherapy (any approach) in the previous 18 months 6. Previous experience on mindfulness or meditation approaches (lifetime)

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Conditions

The condition(s) this trial relates to.

migraine without aura

As listed by the trial registrant

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

Migraine without aura

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

    Milan, Milano, 20133, Italy

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