Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

Change in Headache Severity-pain Intensity From Baseline to Week 12

Modeled change in headache severity-pain intensity from baseline 4 weeks to weeks 8-12. For each headache attack, participants rated the pain intensity on a 0-10 scale (0, no pain sensation, 10 most intense pain sensation imaginable). Higher scores mean a worse outcome in terms of pain intensity.

Time frame: Baseline and 12 weeks

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)

Time frame: Baseline to 6 months post-intervention

Change in Headache Severity-pain Unpleasantness From Baseline to 12 Weeks

Change in headache severity on 0-10 scale (0, "not at all unpleasant" to 10, "most unpleasant imaginable") in pain unpleasantness from baseline 4 weeks to weeks 8-12 (tracked with headache logs).

Time frame: 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

Using a 10 cm sliding visual analogue scale, participants quantified intensity (from "no pain sensation" to "most intense imaginable"), at baseline and at 12 weeks for each of 6 measures at 49 °C. A multivariable linear mixed model was used to model the percent change from baseline in perceived pain intensity at each visit for each of 6 measures at 49 °C. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.

Time frame: Baseline to week 12

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

Using a 10 cm sliding visual analogue scale, participants quantified unpleasantness (from "not at all unpleasant" to "most unpleasant imaginable"). Participants rated perceived pain unpleasantness at baseline and at 12 weeks for each of 6 measures at 49 °C. A multivariable linear mixed model was used to model the percent change from baseline in perceived pain intensity at each visit for each of 6 measures at 49 °C. Change scores were modeled as a function of treatment group and visit, controlling for baseline. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.

Time frame: Baseline to week 12

Change in Experimental Heat Pain Threshold From Baseline to Week 12

Change in Experimental Heat Pain Threshold From Baseline to 12 weeks

Time frame: Baseline to week 12

Change in Headache-related Disability From Baseline

Change in headache-related disability from baseline (Migraine Disability Assessment (MIDAS)-one month) Score range is 0-21+ 0 to 5: MIDAS grade I, little or no disability 6 to 10: MIDAS grade II, mild disability 11 to 20: MIDAS grade III, moderate disability 21 or higher: MIDAS grade IV, severe disability

Time frame: Baseline to Immediately post-intervention

Change in Headache Disability Scores From Baseline

Change in headache-related disability from baseline ( Headache Impact Test (HIT)-6) Headache impact severity level can be categorized using score ranges based on the HIT-6 interpretation guide (29), The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78). Range is 10-78 with higher score = more disability

Time frame: Baseline to Immediately post-intervention

Change in Headache-related Quality of Life Scores From Baseline

Change in headache-related quality of life from baseline (Migraine Specific Quality of Life, v2.1) The Migraine Specific Quality of Life (MSQoL) is a patient-reported outcome measure (PRO or PROM) which assesses the quality of life of migraineurs. It is a 25-item questionnaire which is filled out by the patient and is used to determine how the patient's life has been affected by their migraines - larger scores reflecting greater impact - scores ≤ 49 represent little or no impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact, and scores ≥ 60 indicate severe impact

Time frame: Baseline to Immediately post-intervention

Change in Mindfulness Scores From Baseline

Change in mindfulness from baseline (Five-Facet Mindfulness Scale) - measures the trait-like tendency to be mindful in daily life. It is comprised of the following five related facets: observing, describing, acting with awareness, nonjudging, and nonreactivity - The 39 items of the Five Facet Mindfulness Questionnaire (FFMQ) are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). * Higher scores reflect higher mindfulness scores * Range 39-195 * Subscales are summed for the total score

Time frame: Baseline to Immediately post-intervention

Change in Emotion Regulation Scores From Baseline to 12 Weeks

Change in emotion regulation from baseline (Difficulty Emotion Regulation Scale), Higher scores suggest greater problems with emotion regulation - The total score ranges from 16-80 with higher scores indicating more difficulties with emotion regulation

Time frame: Baseline to week 12

Change in Pain Catastrophizing From Baseline to 12 Weeks

Change in pain catastrophizing from baseline (Pain Catastrophizing Scale) Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52 - higher scores relating to more pain

Time frame: Baseline to Immediately post-intervention (12 weeks)

Change in Pain Acceptance From Baseline to 12 Weeks

Change in pain acceptance from baseline (Chronic Pain Acceptance Questionnaire), higher scores reflect higher levels of pain acceptance; total range 0-156.

Time frame: Baseline and week 12

Change in Perceived Stress From Baseline to 12 Weeks

Change in perceived stress from baseline (Perceived Stress Scale); Score Range: 0-40 with lower scores reflecting lower perceived stress. Ranges: 0-13 Low Stress; 14-26 Moderate Stress; 27-40 High perceived stress.

Time frame: Baseline and week 12

Change in Depression Scores From Baseline

Change in depression from baseline (Patient health-related Questionnaire-depression module, PHQ-9) Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression - The Patient Health Questionnaire-9 (PHQ-9) total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)

Time frame: Baseline to Immediately post-intervention

Change in Anxiety Scores From Baseline

Change in anxiety from baseline (Generalized Anxiety Disorder (GAD-7). Higher Scores suggest a greater level of anxiety. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety - GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)

Time frame: Baseline to Immediately post-intervention

Change in Self-efficacy Scores From Baseline

Change in self-efficacy from baseline (Headache Management Self-Efficacy scale). Higher scores reflect more self-efficacy. The Headache Self-Efficacy Scale is a 51 item scale designed specifically for recurrent headache sufferers. It assesses individuals' belief that they are able to do the things necessary to prevent a moderately painful headache when confronted with personally relevant headache precipitants - The scale has a range of scores from 0-90. A higher number on the score represents a higher self-efficacy for exercise

Time frame: Baseline to Immediately post-intervention

Change in Hope Scores From Baseline to 12 Weeks

Change in hope from baseline (Herth Hope Index); Higher scores suggest higher levels of "Hope." Herth Hope Scale (HHS) is a measure that attempts to capture the multidimensional aspects of hope. This is a 4-point summated rating scale. Each item in the 30-item instrument is scored on a scale from 0 to 3, a score of 3 indicates that the item often applies and a score of 0 indicates that the statement never applies to the respondent. Summative scores can range from 0 to 90; higher scores denote greater hope. In terms of item order, no two consecutive items are from the same subscale.

Time frame: Baseline and week 12

Change in Optimism From Baseline to 12 Weeks

Change in optimism from baseline (Life Orientation Test-revised); Higher scores indicate greater levels of optimism. The Life Orientation Test (LOT) was developed to measure individual differences in optimism versus pessimism. Response options: 5-point Likert scale ranging from 0, "Strongly disagree" to 4, "Strongly agree". Total score: Items are summed, yielding a range from 0 to 32.

Time frame: Baseline to week 12

Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to Week 12

Change in sleep from baseline measured with by NIH Promis Sleep Disturbance; Higher scores indicate greater severity of sleep disturbance; Range from 8-40.

Time frame: Baseline and week 12

Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to 12 Weeks

Change in sleep from baseline measured with by NIH Promis Sleep Disturbance; Higher scores indicate greater severity of sleep disturbance; Range from 8-40.

Time frame: Baseline and week 12

Change in Global Health From Baseline to 12 Weeks

Change in global health from baseline (NIH Promis Global Health-1st question); Range 0-5, 5 highest.

Time frame: Baseline and week 12

Change in Social Connectedness From Baseline to 12 Weeks

Change in social connectedness from baseline (Social Connectedness Scale-revised); Higher scores reflect a higher level of social connection. It is on a likert scale with 1 being strongly disagree to 6 being strongly agree.

Time frame: Baseline to week 12

Change in Flourishing From Baseline to 12 Weeks

Change in flourishing from baseline (Flourishing scale); Higher scores represents a person with many psychological resources and strength; Range from 8-56.

Time frame: Baseline and week 12

Change in Resilience Scores From Baseline to 12 Weeks

Change in resilience from baseline (Brief Resilience scale); higher scores indicate greater levels of resilience; scores range from 6-30

Time frame: Baseline to week 12

Change in Allodynia From Baseline to 12 Weeks

Change in allodynia from baseline (Allodynia Symptom Checklist), score range 0-24, 0-2 none; 3-5 mild; 6-8 moderate; 9+ severe Cutaneous allodynia (CA) scale defining no CA (scores 0-2), mild CA (3-5), moderate CA (6-8), and severe CA (≥9).

Time frame: Baseline to week 12

Change in Number 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

Time frame: Baseline to 6 months post-intervention

Change in Number of Headache Days From Baseline

Change in frequency of any day with a headache tracked with headache logs

Time frame: Baseline to 3 Months post-intervention

Change in Number of Headache Days From Baseline

Change in frequency of any day with a headache tracked with headache logs

Time frame: Baseline to 6 Months post-intervention

Change in Headache Duration From Baseline to 24 Weeks

Modeled change in headache duration from baseline 4 weeks to weeks 20-24 by calculating the duration (in hours) of each headache attack

Time frame: Baseline to 3 Months post-intervention (24 weeks)

Change in Headache Duration From Baseline to 36 Weeks

Modeled change in headache duration from baseline 4 weeks to weeks 32-36 by calculating the duration (in hours) of each headache attack

Time frame: Baseline to 6 Months post-intervention (36 weeks)

Change in Headache Severity-pain Intensity From Baseline to 24 Weeks

change in headache severity-pain intensity from baseline 4 weeks to weeks 20-24 weeks. For each headache attack, participants rated the pain intensity on a 0-10 scale (0, no pain sensation, 10 most intense pain sensation imaginable). We calculated the pain intensity of each headache attack and used a multivariable linear mixed model framework controlling for baseline value of the outcome of interest, treatment group, cohort, and within participant variation via random effects, with significance based on the treatment group effect and phase interaction at .05 significance level.

Time frame: Baseline and 24 weeks

Change in Headache Severity-pain Intensity From Baseline to 36 Weeks

change in headache severity-pain intensity from baseline 4 weeks to weeks 32-36. For each headache attack, participants rated the pain intensity on a 0-10 scale (0, no pain sensation, 10 most intense pain sensation imaginable). We calculated the pain intensity of each headache attack and used a multivariable linear mixed model framework controlling for baseline value of the outcome of interest, treatment group, cohort, and within participant variation via random effects, with significance based on the treatment group effect and phase interaction at .05 significance level.

Time frame: Baseline and 36 weeks

Change in Headache Severity-pain Unpleasantness From Baseline to 24 Weeks

Change in headache severity on 0-10 scale (0, "not at all unpleasant" to 10, "most unpleasant imaginable") in pain unpleasantness from baseline 4 weeks to weeks 20-24 (tracked with headache logs).

Time frame: Baseline and 24 weeks

Change in Headache Severity-pain Unpleasantness From Baseline to Week 36

Change in headache severity on 0-10 scale (0, "not at all unpleasant" to 10, "most unpleasant imaginable") in pain unpleasantness from baseline 4 weeks to weeks 32-36 (tracked with headache logs).

Time frame: Baseline and week 36