Insurance-Reimbursable Mindfulness for Safety-Net Primary Care Patients: a Pilot Randomized Controlled Trial

Objectives Mindfulness is effective for reducing anxiety and depression and increasing chronic disease self-management. An accessible, insurance-reimbursable model for implementation in patient-centered medical homes within US healthcare systems has promise for patients with multi-morbid conditions. Clarifying both the dose needed to impact anxiety, depression and self-management, and the design requirements for accessible primary care implementation, is essential. Methods We tested feasibility, acceptability, and effectiveness of Mindfulness Training for Primary Care (MTPC), an 8-week, referral-based, insurance-reimbursable mindfulness program integrated within primary care, compared with a Low-Dose Comparator (LDC), consisting of a 60-minute mindfulness introduction plus referral to community and digital resources. Outcome measures were assessed at baseline and 8 weeks. MTPC is trauma-informed, incorporates mindfulness-oriented behavior change skills, and is designed to target anxiety, depression, stress, and chronic illness self-management. Participants scheduled a PCP visit to co-create a self-management action plan during week 6. Results Primary care providers (PCP) referred 344 patients over 14 months. Eighty-one participants with DSM-V anxiety disorders, depressive disorders, trauma- and stress-related disorders participated in this pilot randomized-controlled comparative effectiveness trial [MTPC (n=54); LDC (n=27)]. These data suggest that MTPC was more effective than LDC for reducing anxiety (p=0.01), enhancing mindfulness (p=0.02) and self-compassion (p=0.001), and for catalyzing self-management behavior change through action plan initiation (OR=4.34, p=0.03). Conclusions MTPC was successfully integrated into a health system, was billed to insurance, and was acceptable to a diverse primary care population. Replication with a larger study and further accessibility adaptations are needed to confirm and expand these pilot results. Clinical Trials Registration Number: NCT02972203