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Predictors of response to biofeedback-assisted relaxation for migraine: An exploratory analysis
K
J
R
K
M
DOI:10.1177/03331024261441579.png)
Abstract
En 中文
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<jats:title>Background</jats:title>
<jats:p>Few studies have examined which patients with migraine might be responders for mind-body interventions. Thus, we examined whether certain baseline mindfulness traits and interest in physical exercise might predict response to treatment.</jats:p>
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<jats:title>Methods</jats:title>
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This is a planned exploratory analysis of a phase 2 randomized controlled study (
<jats:italic toggle="yes">N</jats:italic>
= 50; 25 per arm) comparing a 6-week physical therapist (PT)-delivered biofeedback-assisted relaxation (BAR) program vs. an Enhanced Usual Care (EUC) migraine self-management program (diary tracking and emailed migraine-related educational materials). We conducted moderation analyses to determine whether the Multidimensional Assessment of Interoceptive Awareness (MAIA), Difficulties in Emotion Regulation Scale (DERS) and Physical Activity Enjoyment Scale (PACES) at baseline influenced the effect of BAR on migraine-related outcomes (Migraine-Specific Quality of Life Role Function Restrictive (MSQv2.1-RFR) and Migraine-Related Disability (MIDAS)) at 6 months.
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<jats:title>Results</jats:title>
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Among the
<jats:italic toggle="yes">n</jats:italic>
= 40 participants (BAR = 19; EUC = 21), the majority were female (95%), non-Hispanic (77.5%) and white (67.5%). Mean (SD) age was 45.6 (11.2) years. For the MAIA Not-Worrying subscale, BAR produced the greatest improvement in 6-month MSQv2.1-RFR scores among participants with low baseline Not-Worrying scores (those who tended to worry about bodily sensations/discomfort more) (BAR = 77.1 ± 6.6 vs. EUC = 48.9 ± 5.0;
<jats:italic toggle="yes">p</jats:italic>
= 0.002,
<jats:italic toggle="yes">g</jats:italic>
= 4.75). The benefit diminished at average levels (
<jats:italic toggle="yes">p</jats:italic>
= 0.060,
<jats:italic toggle="yes">g</jats:italic>
= 2.72) and was absent at high baseline Not-Worrying (
<jats:italic toggle="yes">p</jats:italic>
= 0.528,
<jats:italic toggle="yes">g</jats:italic>
= −0.91). For the MAIA Self-Regulation subscale, BAR was most effective among those low in baseline self-regulation (BAR = 71.7 ± 5.3 vs. EUC = 44.3 ± 7.2;
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= 0.004,
<jats:italic toggle="yes">g</jats:italic>
= 4.27). The DERS total score showed that BAR demonstrated little benefit among participants with better baseline emotion regulation (i.e. lower DERS score;
<jats:italic toggle="yes">p</jats:italic>
= 0.907,
<jats:italic toggle="yes">g</jats:italic>
= 0.17) but was more effective as baseline emotion regulation difficulties increased, showing a moderate benefit at average levels (BAR = 69.2 ± 4.2 vs. EUC = 55.8 ± 4.0,
<jats:italic toggle="yes">p</jats:italic>
= 0.027,
<jats:italic toggle="yes">g</jats:italic>
= 3.25) and a large, significant difference at high levels (BAR = 70.6 ± 6.3 vs. EUC = 44.7 ± 5.7;
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= 0.004,
<jats:italic toggle="yes">g</jats:italic>
= 4.22). The PACES total score indicated that BAR benefits were strongest among those with low (BAR = 76.1 ± 7.0 vs. EUC = 47.1 ± 5.3,
<jats:italic toggle="yes">p</jats:italic>
= 0.002,
<jats:italic toggle="yes">g</jats:italic>
= 4.60) to average (BAR = 71.2 ± 4.2 vs. EUC = 58.6 ± 4.0,
<jats:italic toggle="yes">p</jats:italic>
= 0.035,
<jats:italic toggle="yes">g</jats:italic>
= 3.07) enjoyment of physical activity.
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<jats:title>Conclusions</jats:title>
<jats:p>We found subgroups of individuals with migraine who may be better responders to PT-delivered BAR, specifically those who tend to worry more about bodily sensations (lower MAIA Not-Worrying score), those with low self-regulation (lower MAIA Self-Regulation score), those with worse emotion regulation (higher DERS score) and those with lower levels of physical activity enjoyment (lower PACES score) at baseline. This may help us determine who may benefit most from BAR.</jats:p>
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<jats:title>Trial Registration</jats:title>
<jats:p>ClinicalTrials.gov Identifier: NCT06077812.</jats:p>
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