Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2024-03-17
2026-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MBCT-Telephone
8 weekly classes delivered via telephone.
MBCT-Telephone
Classes follow MBCT protocol delivered via telephone by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
MBCT-Video
8 weekly classes delivered via video.
MBCT-Video
Classes follow MBCT protocol delivered via video by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
Enhanced Usual Care (EUC)
8 weekly online modules delivered via web portal.
Enhanced Usual Care (EUC)
Weekly online modules follow migraine and behavior principles delivered via web portal developed by a team of licensed clinical psychologists, neurologists, and mental health providers.
Interventions
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MBCT-Telephone
Classes follow MBCT protocol delivered via telephone by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
MBCT-Video
Classes follow MBCT protocol delivered via video by a master's level or higher mental health provider under the supervision of a licensed clinical psychologist, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
Enhanced Usual Care (EUC)
Weekly online modules follow migraine and behavior principles delivered via web portal developed by a team of licensed clinical psychologists, neurologists, and mental health providers.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Yeshiva University
OTHER
Wake Forest University Health Sciences
OTHER
The Cleveland Clinic
OTHER
National Center for Complementary and Integrative Health (NCCIH)
NIH
Amanda Shallcross
OTHER
Responsible Party
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Amanda Shallcross
Associate Professor of Medicine
Principal Investigators
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Elizabeth K Seng, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine and Yeshiva University
Amanda J Shallcross, M.P.H., N.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Albert Einstein College of Medicine
The Bronx, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20225608
Identifier Type: -
Identifier Source: org_study_id
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