MRI Outcomes of Mindfulness Meditation for Migraine

Johns Hopkins University

Status: Completed

Conditions: Migraine

Treatments: Behavioral: Stress Management for Headaches; Behavioral: Mindfulness Based Stress Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02133209

NA_00091884

R01AT007176 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including headache frequency and impact and brain activity, will be assessed at baseline, prior to intervention, and at 3-, 6-, and 12-months.

Full description

Subjects in the MBSR group undergo a standardized 8-week MBSR course plus an additional 4 sessions over another 8 weeks that further emphasize and train subjects on MBSR concepts and skills. The SMH group will have 12 sessions spread out in a similar fashion to MBSR. Clinical outcomes are compared between groups at 3, 6, and 12 months to assess efficacy of MBSR. MRI scans are performed at baseline, 3 months, and 6 months changes in MRI metrics after MBSR and changes in MRI metrics associated with long-term MBSR practice. 30 healthy controls will also undergo MRI scanning to determine abnormal brain activity and structure in migraineurs compared to healthy controls across the 6 month period of observation.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Are between 18 and 65 years of age
• Report between 4 and 14 headaches over 28 days
• Have a history of migraines lasting at least 1 year
• Are not currently using opioid ("narcotic") pain medication

Exclusion Criteria

• Are unable to undergo MRI
• Pregnant, lactating, or planning to become pregnant
• Current use of opioid medications

Inclusion Criteria for Healthy Volunteers (same exclusion criteria)

• Are between 18 and 65 years of age
• Free of any acute or chronic pain condition and reports no history of migraines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Stress Management for Headaches

Active Comparator group

Description:

This intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills for managing migraine headaches.

Treatment:

Behavioral: Stress Management for Headaches

Mindfulness Based Stress Reduction

Active Comparator group

Description:

Intervention involves a standardized mindfulness-based stress reduction (MBSR) group intervention following the guidelines originally conceived and developed by the Center for Mindfulness in Medicine, Health Care and Society at the University of Massachusetts. The intervention also included an extended period of training in addition to the usual 8 weeks.

Treatment:

Behavioral: Mindfulness Based Stress Reduction