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NCT05576467Completed

Treatment for Migraine and Mood

Treatment for Migraine and Mood (TEAM-M): A Randomized Controlled Trial of a Mindfulness-based Training Program

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).

Status (registry)
Completed
Study type
Interventional
Enrollment
145 (actual)
First submitted
10 Oct 2022
Start date
17 Mar 2024
Primary completion date
24 Mar 2026
Lead sponsor
Amanda Shallcross
Diseases
Migraine
NCT number
NCT05576467

What you commit to

  • Study type: Interventional
  • Participants enrolled: 145
  • From 17 Mar 2024 to the primary completion date, 24 Mar 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
  • Unwilling to maintain stable current acute or preventive medication dosages for study duration
  • Medication overuse headache with migraine treatment

Other illness

  • 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
  • Any condition that would prevent being a suitable candidate for the group intervention

Other

  • 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 acute migraine treatment started within 4 weeks of enrollment
  • Current daily meditation practice

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Albert Einstein College of Medicine
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
Wake Forest University School of Medicine
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.