• Diana J Burgess, Collin Calvert, Ann Bangerter, Mariah Branson, CrossLee J SLJSCenter for Care Delivery and Outcomes Research, Minneapolis Veterans Affairs Health Care System (VAHCS), Minneapolis, MN 55417, United States., Roni Evans, John E Ferguson, Jessica K Friedman, Emily M Hagel Campbell, Alexander C Haley, Sierra Hennessy, Colleen Kraft, Mallory Mahaffey, Marianne S Matthias, Laura A Meis, J Greg Serpa, Stephanie L Taylor, and Brent C Taylor.
• Center for Care Delivery and Outcomes Research, Minneapolis Veterans Affairs Health Care System (VAHCS), Minneapolis, MN 55417, United States.
• Pain Med. 2024 Nov 1; 25 (Supplement_1): S68S76S68-S76.

BackgroundAlthough mindfulness-based interventions (MBIs) are widely used in clinical and nonclinical settings, there has been little systematic study of their potential risks. To address this gap, we examined differences in psychological and physical worsening among participants in the usual care and intervention conditions of a 3-group, randomized pragmatic trial (Learning to Apply Mindfulness to Pain [LAMP]) that tested the effectiveness of 2 approaches to delivering MBIs to patients with chronic pain.MethodsThe sample consisted of 374 male and 334 female patients with chronic pain enrolled in the LAMP trial who completed a 10-week follow-up survey, 61% of whom had a mental health diagnosis. Psychological and physical worsening was assessed by a checklist asking whether participants experienced specific symptoms since beginning the study. We used multivariable logistic regression models with imputed data to determine whether predicted probabilities of increased symptoms differed between usual care and the 2 MBIs.ResultsParticipants in usual care were more likely to report experiencing increased psychological and physical worsening than were those in the MBIs, including an increase in disturbing memories; sadness, anxiousness, and fatigue; isolation and loneliness; and feeling more upset than usual when something reminded them of the past.ConclusionsMBIs do not appear to cause harm, in terms of increased symptoms, for this population of patients with chronic pain and high levels of mental health comorbidities.Clinical Trial RegistrationPreregistration with an analysis plan at www.ClinicalTrials.gov: NCT04526158. Patient enrollment began December 4, 2020.Published by Oxford University Press on behalf of the American Academy of Pain Medicine.

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