Mindfulness and Mechanisms of Pain Processing in Adults With Migraines
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Change in Frequency of Migraine Days Per Month From Baseline
Study Overview
Brief Summary
Although many adults with migraines use non-pharmacological treatment options, there is a lack of research on the use of many mind/body techniques specifically for headache. This research will further the understanding of the mechanisms, efficacy, and predictors of mind-body practices in adults with migraines.
Detailed Description
Migraine is a common and disabling pain condition. Affective/cognitive processes, such as pain catastrophizing and emotional reactivity, often play a major role in migraine pain and disability. These processes may be just as important to target as the sensory aspect given their impact on outcomes and disability. Because of this cognitive/affective load that builds over time in migraine, we hypothesize A) migraineurs perceive affective pain processing differently than non-migraineurs and B) mind/body therapies that target these factors may be especially beneficial and may differentially impact the affective component of migraine pain. Evidence shows that meditation decreases affective (e.g., pain unpleasantness) over sensory (e.g., pain intensity) response to experimental pain and reduces pain by engaging brain regions important for cognitive and affective modulation of pain. By measuring both experimental and clinical pain, the study team will be able to test these hypotheses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of migraine; ≥18yo; ≥1 yr of migraines; 4-20 days/month with migraines; able and willing to participate in 8 weekly sessions and daily homework 30-45min
Exclusion Criteria
- •Current regular (weekly or more often) practice of meditation; any major unstable medical/psychiatric illness (e.g., hospitalization within 90 days, suicide risk, etc.); other non-migraine chronic pain condition (e.g., fibromyalgia, low back pain, etc.) or sensory abnormalities (e.g., neuropathy, Raynaud's, etc.); diagnosis of medication overuse headache; volunteers with no pain ratings to frankly noxious stimuli (temperatures > 49°C) or excessive responses to threshold temperatures (~43°C); current or planned pregnancy or breastfeeding, any new medication started within 4 weeks of screening visit; unwilling to maintain stable current medication dosages for duration of trial; failure to complete baseline headache logs.
Arms & Interventions
Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.
Intervention: Mindfulness Based Stress Reduction (Other)
Migraine/stress Education
This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Intervention: Migraine/stress Education (Other)
Outcomes
Primary Outcomes
Change in Frequency of Migraine Days Per Month From Baseline
Time Frame: Baseline and immediately post-intervention (12 weeks)
Change in frequency of migraine days from baseline: A migraine day is defined as a calendar day (00:00 to 23:59) when the patient reports 4 or more continuous hours of a moderate to severe headache (rating of 6-10 on 0-10 pain intensity scale) and/or they treated a headache with abortive medication; tracked with headache logs.
Secondary Outcomes
- Change in Frequency of Migraine Days From Baseline(3 months post-intervention)
- Change in Migraine Severity-pain Unpleasantness From Baseline(Baseline to 6 months post-intervention)
- Change in Perceived Stress From Baseline to 12 Weeks(Baseline and week 12)
- Change in Allodynia From Baseline to 12 Weeks(Baseline to week 12)
- Change in Number of Migraine Days From Baseline(Baseline to 6 months post-intervention)
- Change in Headache Severity-pain Unpleasantness From Baseline to Week 36(Baseline and week 36)
- Change in Social Connectedness From Baseline to 12 Weeks(Baseline to week 12)
- Change in Flourishing From Baseline to 12 Weeks(Baseline and week 12)
- Change in Resilience Scores From Baseline to 12 Weeks(Baseline to week 12)
- Change in Number of Headache Days From Baseline(Baseline to 6 Months post-intervention)
- Change in Migraine Severity-pain Intensity From Baseline to Week 12(baseline to Week 12)
- Change in Headache Severity-pain Unpleasantness From Baseline to 12 Weeks(Baseline and 12 weeks)
- Change in Headache-related Disability From Baseline(Baseline to Immediately post-intervention)
- Percent Change in Response Score to Experimental Heat Pain on Pain Unpleasantness Measure From Baseline (0-10) Visual Analogue Scale (VAS Scale) From Baseline to 12 Weeks(Baseline to week 12)
- Change in Frequency of Headache Days From Baseline(Baseline to Immediately post-intervention (12 weeks))
- Change in Headache Duration From Baseline to 12 Weeks(From baseline to Immediately post-intervention (12 weeks))
- Change in Headache Severity-pain Intensity From Baseline to Week 12(Baseline and 12 weeks)
- Percent Change in Score in Response to Experimental Heat Pain on Pain Intensity Measure From Baseline (0-10) Visual Analogue Scale (VAS Scale ) to 12 Weeks(Baseline to week 12)
- Change in Experimental Heat Pain Threshold From Baseline to Week 12(Baseline to week 12)
- Change in Headache Disability Scores From Baseline(Baseline to Immediately post-intervention)
- Change in Headache-related Quality of Life Scores From Baseline(Baseline to Immediately post-intervention)
- Change in Mindfulness Scores From Baseline(Baseline to Immediately post-intervention)
- Change in Pain Catastrophizing From Baseline to 12 Weeks(Baseline to Immediately post-intervention (12 weeks))
- Change in Emotion Regulation Scores From Baseline to 12 Weeks(Baseline to week 12)
- Change in Depression Scores From Baseline(Baseline to Immediately post-intervention)
- Change in Pain Acceptance From Baseline to 12 Weeks(Baseline and week 12)
- Change in Anxiety Scores From Baseline(Baseline to Immediately post-intervention)
- Change in Self-efficacy Scores From Baseline(Baseline to Immediately post-intervention)
- Change in Hope Scores From Baseline to 12 Weeks(Baseline and week 12)
- Change in Optimism From Baseline to 12 Weeks(Baseline to week 12)
- Change in Global Health From Baseline to 12 Weeks(Baseline and week 12)
- Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to Week 12(Baseline and week 12)
- Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to 12 Weeks(Baseline and week 12)
- Change in Headache Duration From Baseline to 24 Weeks(Baseline to 3 Months post-intervention (24 weeks))
- Change in Headache Duration From Baseline to 36 Weeks(Baseline to 6 Months post-intervention (36 weeks))
- Change in Headache Severity-pain Unpleasantness From Baseline to 24 Weeks(Baseline and 24 weeks)
- Change in Headache Severity-pain Intensity From Baseline to 24 Weeks(Baseline and 24 weeks)
- Change in Headache Severity-pain Intensity From Baseline to 36 Weeks(Baseline and 36 weeks)
- Change in Number of Headache Days From Baseline(Baseline to 3 Months post-intervention)