(PS14-66) Characterizing Adverse Events in a Mindfulness Treatment for Migraine and Anxiety

Promising evidence demonstrates that mindfulness-based interventions (MBIs) can reduce pain related discomfort. Thus, there has been a rise in MBI studies focused on reducing pain in people with migraine. Although MBIs are typically considered safe and low-risk interventions, people with migraine may be at a heightened risk of experiencing potential adverse events (PAEs) with MBIs due to psychiatric comorbidities, disease presentation, and trigger hypervigilance. The current study builds on Britton et al.’s 2018 efforts to develop a systematic measure to assess AEs and unwanted events (UEs) in MBIs for migraine.

Patients (n = 38) were recruited through advertisements from a patient advocacy group. They participated in a 6 week mindfulness intervention for co-morbid anxiety and migraine involving a daily mobile health application based on MBSR and weekly facilitated groups via Zoom. Questionnaires were distributed via a secure online platform (Qualtrics) at baseline and immediately following the intervention. Data was collected on migraine disability (MIDAS), migraine intensity and frequency (MIDAS A and B), depression symptoms (PHQ-9), anxiety symptoms (GAD-7), pain catastrophizing (PCS), and interoceptive awareness (MAIA). The Mindfulness Adverse Events Questionnaire for Migraine (MAEQ-M) was given post-intervention. The MAEQ-M is a checklist whereby participants endorse specific adverse events. Follow-up questions ask about event distressingness, impairment, and length of impairment.

Participants had a mean age of 47 (SD = 13.2), were largely female (97.3%), white non-Hispanic (97.3%), and not working (63.2%). All participants who began the intervention completed it, with average session attendance = 4.6/6 (SD = 1.4). Most participants endorsed experiencing at least one UE captured on the MAEQ-M (N = 30, 78.9%). More than half the participants endorsed having a PAE that the participant found at least somewhat distressing (N = 27, 71.1%). Fewer participants reported being impaired by these PAEs (N = 11, 28.9%), with only 3 reporting impairment lasting longer than 1 month. Psychiatric symptoms were the most frequently reported UE and PAE (N = 20, 52.6%; N = 19, 50%). Somatic symptoms were most frequently associated with impairment (N = 7, 18.4%). Pre-treatment scores on candidate variables were not significantly associated with AE reporting, ps < .05. Headache pain intensity post-intervention and depression scores post-intervention were significantly associated with PAE reporting (Spearman’s Rho = .36 [.04, .62]; Spearman’s Rho = .36 [.04, .62], respectively). There were significant differences between the low and high UE reporters post-intervention in depressive symptoms [-8.3, -1.8], anxiety symptoms [-5.2, -.01], and pain catastrophizing [-15.9, -2.0].

This study is the first to characterize which UEs and PAEs are reported by participants with anxiety and migraine during treatment with an MBI. People with migraine commonly reported events they found at least somewhat distressing, with a small minority reporting many distressing events that resulted in impairment. Future work is needed to further refine the MAEQ-M and develop guidelines and thresholds to determine when a UE should be considered adverse.