Mindfulness and Mechanisms of Pain Processing in Adults With Migraines
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ClinicalTrials.gov Identifier: NCT02695498 |
Recruitment Status :
Completed
First Posted : March 1, 2016
Last Update Posted : May 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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Migraine | Other: Mindfulness Based Stress Reduction Other: Migraine/stress Education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 97 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Mindfulness and Mechanisms of Pain Processing in Adults With Migraines |
Study Start Date : | March 2016 |
Actual Primary Completion Date : | July 17, 2019 |
Actual Study Completion Date : | July 17, 2019 |

Arm | Intervention/treatment |
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Experimental: Mindfulness Based Stress Reduction
Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.
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Other: Mindfulness Based Stress Reduction
MBSR is a standardized course in mindfulness mediation and yoga. The participants will meet weekly for 8 weeks for 2.5 hours, plus a "mindfulness retreat day" (approximately 6 hours) after the 6th class [9 total classes.] Mindfulness is cultivated through meditation, body scan (sequential attention to parts of the body), and mindful movement (bodily awareness during gentle stretching, based on yoga). The instructor also gives information about stress and stress relief. |
Experimental: Migraine/stress Education
This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
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Other: Migraine/stress Education
The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. |
- Change in frequency of migraine days from baseline [ Time Frame: Immediately post-intervention ]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
- Change in frequency of migraine days from baseline [ Time Frame: 3 months post-intervention, 6 months post-intervention ]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
- Change in frequency of headache days from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in frequency of any day with a headache tracked with headache logs
- Change in migraine duration from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in duration (in hours) of migraine pain from baseline (tracked with headache logs)
- Change in headache duration from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in duration (in hours) of headache pain from baseline (tracked with headache logs)
- Change in migraine severity-pain intensity from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in migraine pain severity on 0-10 scale in pain intensity from baseline (tracked with headache logs)
- Change in headache severity-pain intensity from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in headache pain severity on 0-10 scale in pain intensity from baseline (tracked with headache logs)
- Change in migraine severity-pain unpleasantness from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in migraine severity on 0-10 scale in pain unpleasantness from baseline (tracked with headache logs)
- Change in headache severity-pain unpleasantness from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in headache severity on 0-10 scale in pain unpleasantness from baseline (tracked with headache logs)
- Change in experimental heat pain intensity from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in response to experimental heat pain on pain intensity measure from baseline (0-10 VAS scale)
- Change in experimental heat pain unpleasantness from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in response to experimental heat pain on pain unpleasantness measure from baseline (0-10 VAS scale)
- Change in experimental heat pain threshold from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in response to experimental heat pain threshold temperature
- Change in headache-related disability from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in headache-related disability from baseline (MIDAS-one month)
- Change in headache disability from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in headache-related disability from baseline (HIT-6)
- Change in headache-related quality of life from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in headache-related quality of life from baseline (Migraine Specific Quality of Life, v2.1)
- Change in mindfulness from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in mindfulness from baseline (Five-Facet Mindfulness Scale)
- Change in emotion regulation from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in emotion regulation from baseline (Difficulty Emotion Regulation Scale)
- Change in pain catastrophizing from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in pain catastrophizing from baseline (Pain Catastrophizing Scale)
- Change in pain acceptance from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in pain acceptance from baseline (Chronic Pain Acceptance Questionnaire)
- Change in perceived stress from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in perceived stress from baseline (Perceived Stress Scale)
- Change in depression from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in depression from baseline (Patient health-related Questionnaire-depression module, PHQ-9)
- Change in anxiety from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in anxiety from baseline (Generalized Anxiety Disorder-GAD-7)
- Change in self-efficacy from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in self-efficacy from baseline (Headache Management Self-Efficacy scale)
- Change in hope from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in hope from baseline (Herth Hope Index)
- Change in optimism from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in optimism from baseline (Life Orientation Test-revised)
- Change in sleep from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in sleep from baseline (NIH Promis Sleep Disturbance)
- Change in sleep from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in sleep from baseline (Pittsburgh Sleep Quality Index)
- Change in global health from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in global health from baseline (NIH Promis Global Health-1st question)
- Change in social connectedness from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in social connectedness from baseline (Social Connectedness Scale-revised)
- Change in flourishing from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in flourishing from baseline (Flourishing scale)
- Change in resilience from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in resilience from baseline (Brief Resilience scale)
- Change in allodynia from baseline [ Time Frame: Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention ]Change in allodynia from baseline (Allodynia Symptom Checklist)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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.

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): NCT02695498
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Rebecca E Wells, MD, MPH | Wake Forest University Health Sciences |
Documents provided by Wake Forest University Health Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT02695498 |
Other Study ID Numbers: |
K23AT008406 ( U.S. NIH Grant/Contract ) |
First Posted: | March 1, 2016 Key Record Dates |
Last Update Posted: | May 14, 2020 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Findings will be disseminated so that providers can implement the results into clinical practice, for scientists to build upon in their research, and for patients to inform treatment decisions. Results will be made publicly available through this website. In addition, results will be published in respected peer-reviewed journals, presented to colleagues at scientific meetings, and discussed with the press. |
Supporting Materials: |
Study Protocol |
Access Criteria: | Please contact Dr. Rebecca Wells for information regarding the study protocol and IRB approvals. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
migraine with aura migraine without aura pain controls mind-body |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |