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Mindfulness by phone or video may ease migraines and low mood

NCT ID NCT05576467

Symptom relief Sponsor: Amanda Shallcross 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tests whether a mindfulness-based program (MBCT) delivered by phone or video can help people with migraines and depressive symptoms. About 145 adults with 4-20 headache days per month and mild to moderate depression will be randomly assigned to phone, video, or usual care. The goal is to see if the program is feasible and acceptable, and whether it reduces headache-related disability.

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

145 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Oct 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 years and older

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: * Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module * Self-reported 4-20 headache days per month * Score between 5-19 on the PHQ-8 * Age ≥ 18 * Ability to read and speak English * Capacity to consent * ≥1 year of migraine Exclusion Criteria: * Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post- traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module * Changes in anti-depressant medication within 6 weeks of intake * Starting or changing a migraine preventive treatment (i.e., oral medication, injection, preventive medicine, neuromodulatory device) within 12 weeks of intake * Changes in acute migraine treatment started within 4 weeks of enrollment * Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT-T intervention, including but not limited to: active suicidal ideation; current or recent history (in the last six months) of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities;, discomfort participating in a group-based intervention, drug use * Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy * Current daily meditation practice * Unwilling to maintain stable current acute or preventive medication dosages for study duration * Any condition that would prevent being a suitable candidate for the group intervention * Medication overuse headache with migraine treatment

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Conditions

The condition(s) this trial relates to.

Depression migraine disorder

As listed by the trial registrant

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

Depressive symptoms Migraine

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

  • The Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.