An interventional study of Mindfulness Based Stress Reduction and Stress Management for Headaches in Migraine, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 98 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Inclusion Criteria for Healthy Volunteers (same exclusion criteria)
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.
Behavioral: Stress Management for Headaches
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.
Behavioral: Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) involves focused attention while practicing moment-to-moment nonjudgmental awareness of the self with the goal of achieving emotional balance and clarity of thought. There will be 8 weekly sessions and a half day retreat followed by 4 bi-weekly sessions over a period of 4 months.
Intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills, headache symptoms and their management, sleep hygiene, and healthy eating. There will be 8 weekly sessions followed by 4 bi-weekly sessions over a period of 4 months.
Change in headache frequency and impact
Headache days per 28 days and headache-related disability (HIT-6)
Time frame: Baseline, 3, 6, and 12 months
Change in gray matter volume
Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
Time frame: Baseline, 3, and 6 months
Change in Brain Function
Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula
Time frame: Baseline, 3, and 6 months
Change in headache intensity
Change in headache intensity
Time frame: Baseline, 3, 6, and 12 months
Change in Brain Structure
Gray matter volume and white matter tracts across the whole brain
Time frame: Baseline, 3, and 6 months
Change in Whole Brain Function
Cognitive-related activity, pain-related activity, and resting state across the whole brain
Time frame: Baseline, 3, and 6 months
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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