Treatment for Migraine and Mood

Description

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).

Conditions

Migraine, Depressive Symptoms

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Study Overview

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Study Details

Study overview

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).

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

Treatment for Migraine and Mood

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

Bronx

Albert Einstein College of Medicine, Bronx, New York, United States, 10461

Winston-Salem

Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States, 27101

Cleveland

The Cleveland Clinic, Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Currently meets ICHD-3 (International Classification for Headache Disorders - 3rd Edition) criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module
  • * Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
  • * Score between 5-14 on the PHQ-9 (Patient Health Questionnaire)
  • * Age ≥ 18
  • * Ability to read and speak English
  • * Capacity to consent
  • * Prospective diary-confirmed 4-14 headache days per month, with at least one attack meeting migraine criteria
  • * ≥1 year of migraine
  • * 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 preventive migraine medication or anti-depressant medication within 6 weeks of intake
  • * Changes in longer-term migraine prevention (onabotulinum toxin A, injectable or oral anti-calcitonin gene related peptide treatment; neuromodulatory device) within 3 months 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 intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities; bipolar disorder; obsessive-compulsive disorder, drug use
  • * Prior history of engaging in formal mindfulness-based interventions including: MBSR (Mindfulness-based stress reduction), MBCT (Mindfulness-based cognitive therapy), Acceptance and Commitment therapy, Dialectical Behavior Therapy
  • * Current daily meditation practice
  • * Inability to adhere to headache diary during baseline evaluation period (recorded fewer than 25/28 days)
  • * Unwilling to maintain stable current acute or preventive medication dosages for study duration
  • * Any condition that would prevent being a suitable candidate or interfere with medical care needs

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amanda Shallcross,

Elizabeth K Seng, Ph.D., PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine and Yeshiva University

Amanda J Shallcross, M.P.H., N.D., PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-07