Aim: We performed a pilot study in order to evaluate the feasibility and to estimate effect sizes of mindfulness-based stress reduction (MBSR) in a sample of patients suffering from migraine. Method: Migraine patients (n = 62, mean age 44 years, 92% female) were randomly allocated to either MBSR or an active control intervention based on progressive muscle relaxation and psychoeducation. The primary outcome was the number of migraine days per month assessed by headache diaries covering one month before and one month after the intervention. Secondary outcomes included functional impairment, use of medication, psychological symptoms, quality of life, pain acceptance, pain self-efficacy, pain perception and self-attributed mindfulness. To measure feasibility, questionnaires assessing study compliance and contentment were administered. Results: The primary outcome migraine frequency showed no significant group difference. Compared to the control group, the MBSR group showed greater improvements in variables of psychological symptoms, pain self-efficacy and sensory pain perception. Within the MBSR condition, all variables showed significant improvements over the course span with effect sizes ranging from d = 0.37 to 0.81, apart from the primary outcome (27% reduction in migraine days, p = 0.07). Compliance and contentment rates were good, supporting the feasibility of the MBSR intervention. Conclusion: Overall, participants in the MBSR group showed more adaptive coping strategies and decreased levels of psychological impairment compared to the control group, indicating a reduced impact of migraine on their everyday lives. It is concluded that this feasibility study demonstrates the ability of mindfulness-based interventions to reduce suffering in patients with migraine.

Background Based on promising effects seen in a pilot study evaluating a generic mindfulness-based program for migraine, we developed a migraine-specific adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The aim of this study was to evaluate this program for feasibility and effectiveness in a randomized controlled trial. Method Fifty-four patients suffering from migraine were randomly allocated to either waitlist or the adapted MBCT. Outcomes were migraine-related parameters as well as variables of psychological functioning and coping. Assessment took place at baseline and post-intervention, for the intervention group also at follow-up (7 months). The effects of the intervention were analyzed by the use of ANCOVAs and linear mixed models. Results With respect to migraine parameters we did not find a significant group difference in the primary outcome (headache-related impairment), but the intervention resulted in a significant reduction of headache frequency (p = .04). In the analysis of secondary outcomes, MBCT showed superiority in four out of eight psychological parameters (perceived stress, anxiety, rumination, catastrophizing) with small to medium effect sizes. The intervention proved to be feasible and participants reported high degrees of contentment and achievement of personal goals. Conclusions The migraine-specific MBCT program did not result in improvements with regard to headache-related impairment but showed a reduction in headache frequency as well as improved psychological functioning in secondary outcomes. Trial Registration This trial was registered in the German Trial Registry “Deutsches Register Klinischer Studien” (ID: DRKS00007477), which is a WHO-listed primary trial register.

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