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Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

This study is currently recruiting participants.
Verified August 2017 by Rebecca Wells, MD, Wake Forest University Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02695498
First Posted: March 1, 2016
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rebecca Wells, MD, Wake Forest University Health Sciences
  Purpose
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 Intervention
Migraine Other: Mindfulness Based Stress Reduction Other: Migraine/stress Education

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rebecca Wells, MD, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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:
  • 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 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 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 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 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 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)


Estimated Enrollment: 98
Study Start Date: March 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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


Contacts
Contact: Rebecca Wells, MD 336-716-2357 Help4Migraines@wakehealth.edu
Contact: Nancy Buchheimer, BS 336-716-3961 nbuchhe@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rebecca Wells, MD    336-716-2357    Help4Migraines@wakehealth.edu   
Contact: Nancy Buchheimer    3367163961    nbuchhe@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Rebecca E Wells, MD Wake Forest University Health Sciences
  More Information

Publications:
Responsible Party: Rebecca Wells, MD, Assistant Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02695498     History of Changes
Other Study ID Numbers: K23AT008406 ( U.S. NIH Grant/Contract )
First Submitted: January 11, 2016
First Posted: March 1, 2016
Last Update Posted: August 17, 2017
Last Verified: August 2017
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.

Keywords provided by Rebecca Wells, MD, 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