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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT007176 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| University of Maryland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Management for Headaches | Active Comparator | 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. |
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| Mindfulness Based Stress Reduction | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in headache frequency and impact | Headache days per 28 days and headache-related disability (HIT-6) | Baseline, 3, 6, and 12 months |
| Change in gray matter volume | Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate | 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 | Baseline, 3, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in headache intensity | Change in headache intensity | Baseline, 3, 6, and 12 months |
| Change in Brain Structure | Gray matter volume and white matter tracts across the whole brain |
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Inclusion Criteria
Exclusion Criteria
Inclusion Criteria for Healthy Volunteers (same exclusion criteria)
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Haythornthwaite, Ph.D. | Johns Hopkins University | Study Director |
| David Seminowicz, Ph.D. | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore | Maryland | 21201 | United States | ||
| Johns Hopkins University, Bayview Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34688253 | Derived | Burrowes SAB, Goloubeva O, Keaser ML, Haythornthwaite JA, Seminowicz DA. Differences in gray matter volume in episodic migraine patients with and without prior diagnosis or clinical care: a cross-sectional study. J Headache Pain. 2021 Oct 23;22(1):127. doi: 10.1186/s10194-021-01340-5. | |
| 34407032 | Derived | Burrowes SAB, Goloubeva O, Stafford K, McArdle PF, Goyal M, Peterlin BL, Haythornthwaite JA, Seminowicz DA. Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. Pain. 2022 Mar 1;163(3):436-444. doi: 10.1097/j.pain.0000000000002372. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| Stress Management for Headaches | Behavioral | 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. |
|
| Baseline, 3, and 6 months |
| Change in Whole Brain Function | Cognitive-related activity, pain-related activity, and resting state across the whole brain | Baseline, 3, and 6 months |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |