MRI Outcomes of Mindfulness Meditation for Migraine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02133209|
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Behavioral: Mindfulness Based Stress Reduction Behavioral: Stress Management for Headaches||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||MRI Outcomes of Mindfulness Meditation for Migraine|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Active Comparator: Stress Management for Headaches
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 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.
Active Comparator: Mindfulness Based Stress Reduction
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.
- Change in headache frequency and impact [ Time Frame: Baseline, 3, 6, and 12 months ]Headache days per 28 days and headache-related disability (HIT-6)
- Change in gray matter volume [ Time Frame: Baseline, 3, and 6 months ]Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
- Change in Brain Function [ Time Frame: Baseline, 3, and 6 months ]Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula
- Change in headache intensity [ Time Frame: Baseline, 3, 6, and 12 months ]Change in headache intensity
- Change in Brain Structure [ Time Frame: Baseline, 3, and 6 months ]Gray matter volume and white matter tracts across the whole brain
- Change in Whole Brain Function [ Time Frame: Baseline, 3, and 6 months ]Cognitive-related activity, pain-related activity, and resting state across the whole brain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133209
|United States, Maryland|
|University of Maryland School of Dentistry|
|Baltimore, Maryland, United States, 21201|
|Johns Hopkins University, Bayview Medical Campus|
|Baltimore, Maryland, United States, 21224|
|Study Director:||Jennifer A Haythornthwaite, Ph.D.||Johns Hopkins University|
|Principal Investigator:||David Seminowicz, Ph.D.||University of Maryland|