Back to resultsMindfulness and Mechanisms of Pain Processing in Adults With Migraines
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Migraine/stress Education
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring migraine with aura, migraine without aura, pain, controls, mind-body
Eligibility 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.
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mindfulness Based Stress Reduction
Migraine/stress Education
Arm Description
Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.
This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Outcomes
Primary Outcome Measures
Change in frequency of migraine days from baseline
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
Change in frequency of migraine days from baseline
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
Change in frequency of any day with a headache tracked with headache logs
Change in migraine duration from baseline
Change in duration (in hours) of migraine pain from baseline (tracked with headache logs)
Change in headache duration from baseline
Change in duration (in hours) of headache pain from baseline (tracked with headache logs)
Change in migraine severity-pain intensity from baseline
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
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
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
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
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
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
Change in response to experimental heat pain threshold temperature
Change in headache-related disability from baseline
Change in headache-related disability from baseline (MIDAS-one month)
Change in headache disability from baseline
Change in headache-related disability from baseline (HIT-6)
Change in headache-related quality of life from baseline
Change in headache-related quality of life from baseline (Migraine Specific Quality of Life, v2.1)
Change in mindfulness from baseline
Change in mindfulness from baseline (Five-Facet Mindfulness Scale)
Change in emotion regulation from baseline
Change in emotion regulation from baseline (Difficulty Emotion Regulation Scale)
Change in pain catastrophizing from baseline
Change in pain catastrophizing from baseline (Pain Catastrophizing Scale)
Change in pain acceptance from baseline
Change in pain acceptance from baseline (Chronic Pain Acceptance Questionnaire)
Change in perceived stress from baseline
Change in perceived stress from baseline (Perceived Stress Scale)
Change in depression from baseline
Change in depression from baseline (Patient health-related Questionnaire-depression module, PHQ-9)
Change in anxiety from baseline
Change in anxiety from baseline (Generalized Anxiety Disorder-GAD-7)
Change in self-efficacy from baseline
Change in self-efficacy from baseline (Headache Management Self-Efficacy scale)
Change in hope from baseline
Change in hope from baseline (Herth Hope Index)
Change in optimism from baseline
Change in optimism from baseline (Life Orientation Test-revised)
Change in sleep from baseline
Change in sleep from baseline (NIH Promis Sleep Disturbance)
Change in sleep from baseline
Change in sleep from baseline (Pittsburgh Sleep Quality Index)
Change in global health from baseline
Change in global health from baseline (NIH Promis Global Health-1st question)
Change in social connectedness from baseline
Change in social connectedness from baseline (Social Connectedness Scale-revised)
Change in flourishing from baseline
Change in flourishing from baseline (Flourishing scale)
Change in resilience from baseline
Change in resilience from baseline (Brief Resilience scale)
Change in allodynia from baseline
Change in allodynia from baseline (Allodynia Symptom Checklist)
Full Information
NCT ID
NCT02695498
First Posted
January 11, 2016
Last Updated
May 11, 2020
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02695498
Brief Title
Mindfulness and Mechanisms of Pain Processing in Adults With Migraines
Official Title
Mindfulness and Mechanisms of Pain Processing in Adults With Migraines
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine with aura, migraine without aura, pain, controls, mind-body
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Stress Reduction
Arm Type
Experimental
Arm Description
Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga.
Arm Title
Migraine/stress Education
Arm Type
Experimental
Arm Description
This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Intervention Type
Other
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Migraine/stress Education
Intervention Description
The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Primary Outcome Measure Information:
Title
Change in frequency of migraine days from baseline
Description
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
Time Frame
Immediately post-intervention
Secondary Outcome Measure Information:
Title
Change in frequency of migraine days from baseline
Description
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
Time Frame
3 months post-intervention, 6 months post-intervention
Title
Change in frequency of headache days from baseline
Description
Change in frequency of any day with a headache tracked with headache logs
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in migraine duration from baseline
Description
Change in duration (in hours) of migraine pain from baseline (tracked with headache logs)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in headache duration from baseline
Description
Change in duration (in hours) of headache pain from baseline (tracked with headache logs)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in migraine severity-pain intensity from baseline
Description
Change in migraine pain severity on 0-10 scale in pain intensity from baseline (tracked with headache logs)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in headache severity-pain intensity from baseline
Description
Change in headache pain severity on 0-10 scale in pain intensity from baseline (tracked with headache logs)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in migraine severity-pain unpleasantness from baseline
Description
Change in migraine severity on 0-10 scale in pain unpleasantness from baseline (tracked with headache logs)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in headache severity-pain unpleasantness from baseline
Description
Change in headache severity on 0-10 scale in pain unpleasantness from baseline (tracked with headache logs)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in experimental heat pain intensity from baseline
Description
Change in response to experimental heat pain on pain intensity measure from baseline (0-10 VAS scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in experimental heat pain unpleasantness from baseline
Description
Change in response to experimental heat pain on pain unpleasantness measure from baseline (0-10 VAS scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in experimental heat pain threshold from baseline
Description
Change in response to experimental heat pain threshold temperature
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in headache-related disability from baseline
Description
Change in headache-related disability from baseline (MIDAS-one month)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in headache disability from baseline
Description
Change in headache-related disability from baseline (HIT-6)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in headache-related quality of life from baseline
Description
Change in headache-related quality of life from baseline (Migraine Specific Quality of Life, v2.1)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in mindfulness from baseline
Description
Change in mindfulness from baseline (Five-Facet Mindfulness Scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in emotion regulation from baseline
Description
Change in emotion regulation from baseline (Difficulty Emotion Regulation Scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in pain catastrophizing from baseline
Description
Change in pain catastrophizing from baseline (Pain Catastrophizing Scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in pain acceptance from baseline
Description
Change in pain acceptance from baseline (Chronic Pain Acceptance Questionnaire)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in perceived stress from baseline
Description
Change in perceived stress from baseline (Perceived Stress Scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in depression from baseline
Description
Change in depression from baseline (Patient health-related Questionnaire-depression module, PHQ-9)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in anxiety from baseline
Description
Change in anxiety from baseline (Generalized Anxiety Disorder-GAD-7)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in self-efficacy from baseline
Description
Change in self-efficacy from baseline (Headache Management Self-Efficacy scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in hope from baseline
Description
Change in hope from baseline (Herth Hope Index)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in optimism from baseline
Description
Change in optimism from baseline (Life Orientation Test-revised)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in sleep from baseline
Description
Change in sleep from baseline (NIH Promis Sleep Disturbance)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in sleep from baseline
Description
Change in sleep from baseline (Pittsburgh Sleep Quality Index)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in global health from baseline
Description
Change in global health from baseline (NIH Promis Global Health-1st question)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in social connectedness from baseline
Description
Change in social connectedness from baseline (Social Connectedness Scale-revised)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in flourishing from baseline
Description
Change in flourishing from baseline (Flourishing scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in resilience from baseline
Description
Change in resilience from baseline (Brief Resilience scale)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
Title
Change in allodynia from baseline
Description
Change in allodynia from baseline (Allodynia Symptom Checklist)
Time Frame
Baseline, Immediately post-intervention, 3 months post-intervention, 6 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Wells, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Access Criteria
Please contact Dr. Rebecca Wells for information regarding the study protocol and IRB approvals.
Citations:
PubMed Identifier
25041058
Citation
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.
Results Reference
background
PubMed Identifier
33315046
Citation
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.
Results Reference
derived
Learn more about this trial
Mindfulness and Mechanisms of Pain Processing in Adults With Migraines
We'll reach out to this number within 24 hrs