Trial Outcomes & Findings for Mindfulness and Mechanisms of Pain Processing in Adults With Migraines (NCT NCT02695498)

NCT ID: NCT02695498

Last Updated: 2023-11-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 89 participants
• Primary outcome timeframe: Baseline and immediately post-intervention (12 weeks)
• Results posted on: 2023-11-27

Participant Flow

Participant milestones

Measure	Mindfulness Based Stress Reduction Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Overall Study STARTED	45	44
Overall Study COMPLETED	45	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness and Mechanisms of Pain Processing in Adults With Migraines

Baseline characteristics by cohort

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.	Total n=89 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 12 • n=5 Participants	44 years STANDARD_DEVIATION 14 • n=7 Participants	44 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	44 participants n=7 Participants	89 participants n=5 Participants
Body Mass Index (BMI)	27 kg/m^2 STANDARD_DEVIATION 8 • n=5 Participants	29 kg/m^2 STANDARD_DEVIATION 7 • n=7 Participants	28 kg/m^2 STANDARD_DEVIATION 7.48 • n=5 Participants
Systolic Blood Pressure	120 mm Hg STANDARD_DEVIATION 16.5 • n=5 Participants	122 mm Hg STANDARD_DEVIATION 12.9 • n=7 Participants	121 mm Hg STANDARD_DEVIATION 14.6 • n=5 Participants
Diastolic Blood Pressure	73 mm Hg STANDARD_DEVIATION 11.4 • n=5 Participants	73 mm Hg STANDARD_DEVIATION 8.8 • n=7 Participants	73 mm Hg STANDARD_DEVIATION 10 • n=5 Participants
Heart Rate	73 beats per minute STANDARD_DEVIATION 13 • n=5 Participants	78 beats per minute STANDARD_DEVIATION 13 • n=7 Participants	75.5 beats per minute STANDARD_DEVIATION 13.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and immediately post-intervention (12 weeks)

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. 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 Per Month From Baseline	-1.6 number of days Interval -2.5 to -0.7	-2.0 number of days Interval -2.9 to -1.1

SECONDARY outcome

Timeframe: 3 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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. 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	-2.2 days Interval -3.2 to -1.1	-1.98 days Interval -3.1 to -0.9

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention (12 weeks)

Population: only reporting 'headache' duration (not 'migraine' duration) (e.g., data were not collected)

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to Immediately post-intervention (12 weeks)

Population: Data were not collected)

Modeled change in headache duration from baseline 4 weeks to weeks 8-12 by calculating the duration (in hours) of each headache attack and using 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to Week 12

Population: Our multivariable linear model resulted in a 95% confidence interval for the difference between the 2 values from the two Groups

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). We calculated the pain intensity of each headache attack and used a multivariable linear 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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Migraine Severity-pain Intensity From Baseline to Week 12	-0.142 score on a scale Interval -0.738 to 0.0997	-.177 score on a scale Interval -0.738 to 0.0997

SECONDARY outcome

Timeframe: Baseline and 12 weeks

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache Severity-pain Intensity From Baseline to Week 12	0.142 score on a scale Interval -0.156 to 0.44	-0.177 score on a scale Interval -0.472 to 0.117

SECONDARY outcome

Timeframe: Baseline to 6 months post-intervention

Change in migraine severity on 0-10 scale in pain unpleasantness from baseline (tracked with headache logs)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 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).

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache Severity-pain Unpleasantness From Baseline to 12 Weeks	.1745 score on a scale Interval -0.189 to 0.538	-0.0884 score on a scale Interval -0.447 to 0.27

SECONDARY outcome

Timeframe: Baseline to week 12

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
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	-36.3 percentage of change Interval -60.3 to -12.3	13.5 percentage of change Interval -9.9 to 36.8

SECONDARY outcome

Timeframe: Baseline to week 12

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
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	-30.4 percentage of change Interval -49.4 to -9.9	11.2 percentage of change Interval -8.9 to 31.2

SECONDARY outcome

Timeframe: Baseline to week 12

Change in Experimental Heat Pain Threshold From Baseline to 12 weeks

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Experimental Heat Pain Threshold From Baseline to Week 12	0.096 Degree Celsius Interval -0.656 to 0.858	0.162 Degree Celsius Interval -0.619 to 0.943

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache-related Disability From Baseline	-7.6 score on a scale Interval -10.1 to -5.0	-1.7 score on a scale Interval -4.1 to 0.8

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache Disability Scores From Baseline	-6.5 score on a scale Interval -8.4 to -4.6	-1.2 score on a scale Interval -3.0 to 0.6

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache-related Quality of Life Scores From Baseline	33.6 score on a scale Interval 30.5 to 36.6	38.6 score on a scale Interval 35.6 to 41.6

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Mindfulness Scores From Baseline	4.1 score on a scale Interval -0.3 to 8.5	0.4 score on a scale Interval -3.8 to 4.6

SECONDARY outcome

Timeframe: Baseline to week 12

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Emotion Regulation Scores From Baseline to 12 Weeks	-3.4 score on a scale Interval -7.42 to 0.57	0.46 score on a scale Interval -3.45 to 4.37

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention (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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Pain Catastrophizing From Baseline to 12 Weeks	-6.4 score on a scale Interval -8.9 to -3.9	-0.7 score on a scale Interval -3.2 to 1.7

SECONDARY outcome

Timeframe: Baseline and week 12

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Pain Acceptance From Baseline to 12 Weeks	5.36 score on a scale Interval 2.44 to 8.28	1.89 score on a scale Interval -0.94 to 4.72

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Our multivariable linear model resulted in a 95% confidence interval for the difference between the 2 values from the two Groups

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Perceived Stress From Baseline to 12 Weeks	-2.65 score on a scale Interval -4.41 to -0.895	-1.78 score on a scale Interval -3.48 to -0.0845

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention

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)

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Depression Scores From Baseline	-1.0 score on a scale Interval -2.0 to -0.02	0.6 score on a scale Interval -0.4 to 1.6

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention

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)

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Anxiety Scores From Baseline	-1.6 score on a scale Interval -2.6 to -0.5	-0.2 score on a scale Interval -1.2 to 0.8

SECONDARY outcome

Timeframe: Baseline to Immediately post-intervention

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Self-efficacy Scores From Baseline	15.6 score on a scale Interval 9.2 to 22.1	6.8 score on a scale Interval 0.6 to 13.0

SECONDARY outcome

Timeframe: Baseline and week 12

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Hope Scores From Baseline to 12 Weeks	0.165 score on a scale Interval -0.94 to 1.27	-0.046 score on a scale Interval -1.131 to 1.039

SECONDARY outcome

Timeframe: Baseline to week 12

Population: Our multivariable linear model resulted in a 95% confidence interval for the difference between the 2 values from the two Groups

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Optimism From Baseline to 12 Weeks	-0.771 score on a scale Interval -1.61 to 0.067	-0.171 score on a scale Interval -0.993 to 0.65

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Our multivariable linear model resulted in a 95% confidence interval for the difference between the 2 values from the two Groups

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Sleep From Baseline - (NIH Promis Sleep Disturbance) to Week 12	-1.68 score on a scale Interval -3.29 to -0.079	0.9784 score on a scale Interval -0.601 to 2.558

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Data were not collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and week 12

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Global Health From Baseline to 12 Weeks	3.48 score on a scale Interval 3.23 to 3.74	3.23 score on a scale Interval 2.98 to 3.48

SECONDARY outcome

Timeframe: Baseline to week 12

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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Social Connectedness From Baseline to 12 Weeks	-1.00 score on a scale Interval -3.57 to 1.56	-.447 score on a scale Interval -2.97 to 2.08

SECONDARY outcome

Timeframe: Baseline and week 12

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Flourishing From Baseline to 12 Weeks	1.07 score on a scale Interval -0.71 to 2.85	-0.10 score on a scale Interval -1.85 to 1.65

SECONDARY outcome

Timeframe: Baseline to week 12

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Resilience Scores From Baseline to 12 Weeks	0.238 score on a scale Interval -0.793 to 1.269	-0.486 score on a scale Interval -1.497 to 0.525

SECONDARY outcome

Timeframe: Baseline to week 12

Population: Data were not collected

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Number of Migraine Days From Baseline	-2.2 change in the number of days Interval -3.2 to -1.2	-2.7 change in the number of days Interval -3.8 to -1.7

SECONDARY outcome

Timeframe: Baseline to 3 Months post-intervention

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Number of Headache Days From Baseline	-3.18 change in Number of days Interval -4.3 to -2.0	-3.7 change in Number of days Interval -4.8 to -2.5

SECONDARY outcome

Timeframe: Baseline to 6 Months post-intervention

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

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Number of Headache Days From Baseline	-3.2 change in Number of days Interval -4.4 to -1.9	-4.1 change in Number of days Interval -5.4 to -2.8

SECONDARY outcome

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

Population: Data were not collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data were not collected

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache Severity-pain Intensity From Baseline to 24 Weeks	0.111 score on a scale Interval -0.238 to 0.46	-0.1666 score on a scale Interval -0.509 to 0.178

SECONDARY outcome

Timeframe: Baseline and 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.

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache Severity-pain Intensity From Baseline to 36 Weeks	0.1049 score on a scale Interval -0.374 to 0.584	0.047 score on a scale Interval -0.473 to 0.567

SECONDARY outcome

Timeframe: Baseline and 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).

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache Severity-pain Unpleasantness From Baseline to 24 Weeks	-0.107 score on a scale Interval -0.499 to 0.285	-0.046 score on a scale Interval -0.432 to 0.34

SECONDARY outcome

Timeframe: Baseline and 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).

Outcome measures

Measure	Mindfulness Based Stress Reduction n=45 Participants Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 Participants This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Change in Headache Severity-pain Unpleasantness From Baseline to Week 36	-0.0811 score on a scale Interval -0.573 to 0.411	0.0977 score on a scale Interval -0.437 to 0.632

Adverse Events

Mindfulness Based Stress Reduction

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Migraine/Stress Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mindfulness Based Stress Reduction n=45 participants at risk Mindfulness Based Stress Reduction (MBSR) is a standardized course in mindfulness mediation and yoga. 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.	Migraine/Stress Education n=44 participants at risk This course will educate participants about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings. Migraine/stress Education: The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) squamous cell carcinoma	2.2% 1/45 • Number of events 1 • 36 weeks Adverse events were systematically queried and tracked at each study visit.	0.00% 0/44 • 36 weeks Adverse events were systematically queried and tracked at each study visit.

Additional Information

Rebecca Wells, MD, MPH

Atrium Health Wake Forest Baptist

Phone: 336-716-2357

Email: rewells@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place