Migraine
Conditions
Keywords
migraine, headache, meditation, mindfulness based stress reduction, MBSR
Brief summary
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.
Detailed 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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in headache frequency and impact | Baseline, 3, 6, and 12 months | Headache days per 28 days and headache-related disability (HIT-6) |
| Change in gray matter volume | Baseline, 3, and 6 months | Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate |
| Change in Brain Function | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in headache intensity | Baseline, 3, 6, and 12 months | Change in headache intensity |
| Change in Brain Structure | Baseline, 3, and 6 months | Gray matter volume and white matter tracts across the whole brain |
| Change in Whole Brain Function | Baseline, 3, and 6 months | Cognitive-related activity, pain-related activity, and resting state across the whole brain |
Countries
United States