Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

• ClinicalTrials.gov Identifier: NCT02695498
• Recruitment Status: Completed
• First Posted: March 1, 2016
• Last Update Posted: May 14, 2020
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine	Other: Mindfulness Based Stress Reduction; Other: Migraine/stress Education	Not Applicable

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 (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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mindfulness Based Stress Reduction; Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.	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.	Other: Migraine/stress Education; The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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)
4. 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)
5. 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)
6. 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)
7. 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)
8. 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)
9. 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)
10. 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)
11. 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
12. 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)
13. 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)
14. 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)
15. 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)
16. 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)
17. 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)
18. 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)
19. 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)
20. 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)
21. 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)
22. 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)
23. 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)
24. 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)
25. 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)
26. 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)
27. 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)
28. 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)
29. 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)
30. 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)
31. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Rebecca E Wells, MD, MPH; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Informed Consent Form  [PDF] November 25, 2015

More Information

Publications:

Wells RE, Burch R, Paulsen RH, Wayne PM, Houle TT, Loder E. Meditation for migraines: a pilot randomized controlled trial. Headache. 2014 Oct;54(9):1484-95. doi: 10.1111/head.12420. Epub 2014 Jul 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wells RE, O'Connell N, Pierce CR, Estave P, Penzien DB, Loder E, Zeidan F, Houle TT. Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. JAMA Intern Med. 2021 Mar 1;181(3):317-328. doi: 10.1001/jamainternmed.2020.7090.

• 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
• 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

Keywords provided by Wake Forest University Health Sciences:

migraine with aura; migraine without aura; pain; controls; mind-body

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases