Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-07-31
2019-02-28
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
SINGLE
Study Groups
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MBCT for Migraine
In this arm, participants will receive 8 weeks of the manualized treatment Mindfulness Based Cognitive Therapy (MBCT; Day \& Thorn). Participants will attend weekly 75-90 minute individual sessions for eight weeks. At each weekly session one of eight broad topics are addressed and discussed (Automatic-Pilot, Dealing with Barriers, Mindfulness of Breath, Staying Present, Allowing/Letting Be, Cognitive Restructuring, Self Care, Application to Headache Pain). Homework is assigned each week, and participants are expected to develop a daily formal mindfulness practice (body scan meditation, seated meditation, breathing meditation, etc). Participants are provided with a course manual, reading materials, and audio recordings to facilitate meditation practice.
MBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
Wait List/Treatment as Usual
Patients will continue with standard care. Patients will be offered MBCT after the primary endpoint.
No interventions assigned to this group
Interventions
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MBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
Eligibility Criteria
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Inclusion Criteria
* self-reported and diary-confirmed 4-20 headache days per month
* aged 18-65
* ability to read English
* capacity to consent.
Exclusion Criteria
* fewer than 4 or greater than 20 headache days per month
* under 18 or over 65
* inability to read English
* lacking the capacity to consent
* utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study
* severe psychiatric illness that would interfere with participation in the treatment
18 Years
65 Years
ALL
No
Sponsors
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Albert Einstein College of Medicine
OTHER
Responsible Party
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Elizabeth Seng
Assistant Professor
Principal Investigators
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Elizabeth K Seng, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yeshiva University/Albert Einstein College of Medicine
Locations
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Yeshiva University
The Bronx, New York, United States
Countries
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References
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Best RD, Ozmeral A, Grinberg AS, Smitherman TA, Seng EK. Pain acceptance as a change mechanism for mindfulness-based cognitive therapy for migraine. J Behav Med. 2024 Jun;47(3):471-482. doi: 10.1007/s10865-024-00475-5. Epub 2024 Feb 26.
Seng EK, Conway AB, Grinberg AS, Patel ZS, Marzouk M, Rosenberg L, Metts C, Day MA, Minen MT, Buse DC, Lipton RB. Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. Neurol Clin Pract. 2021 Jun;11(3):194-205. doi: 10.1212/CPJ.0000000000000984.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2015-4684
Identifier Type: -
Identifier Source: org_study_id
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