Table 2. Changes in Standardized Instruments Over Time in Mindfulness-Based Stress Reduction (MBSR) vs Headache Educationa.
| Instrument | Mean (95% CI) | Point estimate of effect difference between groups (95% CI)c | P value | |||
|---|---|---|---|---|---|---|
| Baseline | 12 weeksb | 24 weeksb | 36 weeksb | |||
| Migraine Disability Assessment-1 month (MIDAS)d | ||||||
| MBSR | 16.9 (12.3 to 21.5)e | 6.7 (4.1 to 9.2) | 6.4 (3.8 to 9.1) | 5.2 (2.6 to 7.8) | 5.9 (2.8 to 9.0) | <.001 |
| Headache education | 11.8 (9.5 to 14.4) | 12.6 (10.1 to 15.1) | 12.4 (9.8 to 15.0) | 11.1 (8.5 to 13.7) | ||
| Pain Catastrophizing Scale (PCS)f | ||||||
| MBSR | 18.5 (14.9 to 22.1) | 13.3 (10.9 to 15.6) | 13.0 (10.6 to 15.5) | 9.8 (7.4 to 12.1) | 5.8 (2.9 to 8.8) | <.001 |
| Headache education | 20.8 (16.9 to 24.6) | 19.1 (16.8 to 21.3) | 18.8 (16.5 to 21.2) | 15.6 (13.2 to 17.9) | ||
| Patient Health Questionnaire 9 Depression (PHQ-9)g | ||||||
| MBSR | 4.7 (3.3 to 6.1) | 3.9 (3.0 to 4.9) | 4.0 (3.0 to 4.9) | 3.6 (2.6 to 4.5) | 1.6 (0.4 to 2.7) | .008 |
| Headache education | 5.5 (4.2 to 6.8) | 5.5 (4.6 to 6.4) | 5.6 (4.6 to 6.5) | 5.1 (4.2 to 6.1) | ||
| Migraine Specific Quality of Life (MSQv2.1)h | ||||||
| MBSR | 44.9 (40.0 to 49.7) | 33.6 (30.5 to 36.6) | 29.9 (26.7 to 33.1) | 29.6 (26.5 to 32.8) | 5.1 (1.2 to 8.9) | .01 |
| Headache education | 43.5 (40.0 to 47.1) | 38.6 (35.6 to 41.6) | 35.0 (31.9 to 38.1) | 34.7 (31.6 to 37.8) | ||
| Headache Management Self-Efficacy (HMSE)i | ||||||
| MBSR | 110 (103 to 118) | 127 (121 to 133) | 128 (122 to 134) | 129 (123 to 135) | 8.2 (0.3 to 16.1) | .04 |
| Headache education | 114 (107 to 122) | 119 (113 to 125) | 120 (114 to 126) | 121 (115 to 127) | ||
| Generalized Anxiety Disorder (GAD-7)j | ||||||
| MBSR | 12.1 (10.8 to 13.5) | 11.0 (10.0 to 12.0) | 10.8 (9.8 to 11.8) | 10.9 (9.85 to 11.9) | 1.2 (−0.05 to 2.4) | .06 |
| Headache education | 12.7 (11.3 to 14.1) | 12.2 (11.2 to 13.1) | 12.0 (11.0 to 13.0) | 12.1 (11.06 to 13.0) | ||
| Five Facet Mindfulness (FFM)k | ||||||
| MBSR | 138 (132 to 144) | 140 (136 to 144) | 142 (138 to 147) | 143 (139 to 148) | 3.9 (−1.5 to 9.3) | .15 |
| Headache education | 134 (128 to 139) | 136 (132 to 140) | 138 (134 to 143) | 140 (135 to 144) | ||
| Headache Impact Test (HIT-6)l | ||||||
| MBSR | 63.0 (60.8 to 65.2) | 56.3 (54.4 to 58.2) | 57.9 (55.8 to 59.9) | 56.6 (54.6 to 58.6) | 5.3 (2.7 to 7.9)m; 0.9 (−1.9 to 3.6)n; 1.9 (−0.9 to 4.6)o | <.001m; .54n; .19o |
| Headache education | 63.0 (61.8 to 64.3) | 61.6 (59.8 to 63.4) | 58.7 (56.8 to 60.7) | 58.5 (56.5 to 60.4) | ||
Results represent n = 78 (participants with at least 1 follow-up visit).
Multivariable linear mixed regression model was used to assess instrument means by follow-up visit and treatment group, adjusted for baseline measures with random intercepts for each patient. For all but HIT-6, follow-up means are based on main-effects from the linear mixed regression model without an interaction effect between treatment group and time due to insignificant interaction effects. For HIT-6, means are based on results from a significant treatment – time interaction effect.
Treatment effect measures evaluated from baseline across all 3 follow-up time points. The effect difference is in terms of a positive clinical improvement in the MBSR group relative to the headache education group (eg, a greater reduction in MIDAS or increase in FFM). Statistically significant differences between treatment groups for each time point are the same as denoted in Figure 3 (represented in the figure with Cohen d effect sizes).
Instrument score ranges: Migraine Disability Assessment-one month (0-93), higher scores reflect greater disability, MIDAS is typically used as an average over 3 months; to facilitate interpretation of the MIDAS-1 month data presented, the mean estimate results (but not the confidence intervals) can be multiplied by 3 for conversion to the typical 3-month assessment61; score range for 3-month MIDAS: 0-5: little or no disability, 6-10 mild disability, 11-20 moderate disability, 21+ severe disability.
There was not a statistically significant difference in baseline measures for all instruments except MIDAS. Baseline difference between treatment groups in MIDAS is statistically significant (P = .033). There were 3 identified outlier patients in the MBSR group with baseline MIDAS scores >50 (for reference, the maximum baseline MIDAS in the Headache Education group was 36). With these outliers removed, the mean baseline MIDAS in the MBSR group is 14.44 (11.75, 17.14) and the baseline difference between treatment groups is no longer statistically significant (P = .20).
Pain Catastrophizing Scale (0-52), higher scores reflect greater pain catastrophizing.
Patient Health Questionnaire-9 Depression (0-27), higher scores reflect greater depression, score range: 1-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe depression, 20-27: severe depression.
Migraine Specific Quality of Life (0-100), lower scores reflect greater quality of life.
Headache Management Self-Efficacy (0-175), higher scores reflect more self-efficacy.
Generalized Anxiety Disorder-7 (0-21), higher scores reflect greater anxiety, score range: 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, 15-21 severe anxiety.
Five Facet Mindfulness (0-195), higher scores reflect greater mindfulness.
Headache Impact Test-6 (36-78), higher scores reflect greater headache impact, score range: <49: little to no impact, 50-55: some/moderate impact, 56-59: substantial impact, 60+ severe impact. HIT-6 point estimates of effect differences between groups are displayed at three time points due to a significant treatment-visit interaction. All other instrument treatment effect measures did not significantly differ across visits (P > .05).
12 weeks.
24 weeks.
36 weeks.