Mindfulness Training Enhances Self-Regulation and Facilitates Health Behavior Change for Primary Care Patients: a Randomized Controlled Trial.

BACKGROUND: Self-management of health is important for improving health outcomes among primary care patients with chronic disease. Anxiety and depressive disorders are common and interfere with self-regulation, which is required for disease self-management. An insurance-reimbursable mindfulness intervention integrated within primary care may be effective for enhancing chronic disease self-management behaviors among primary care patients with anxiety, depression, trauma, and stress-related and adjustment disorders compared with the increasingly standard practice of referring patients to outside mindfulness resources. OBJECTIVE: Mindfulness Training for Primary Care (MTPC) is an 8-week, referral-based, insurance-reimbursable program integrated into safety-net health system patient-centered medical homes. We hypothesized that MTPC would be more effective for catalyzing chronic disease self-management action plan initiation within 2 weeks, versus a low-dose comparator (LDC) consisting of a 60-min mindfulness introduction, referral to community and digital resources, and addition to a 6-month waitlist for MTPC. PARTICIPANTS: Primary care providers (PCPs) and mental health clinicians referred 465 patients over 12 months. All participants had a DSM-V diagnosis. DESIGN AND INTERVENTIONS: Participants (N = 136) were randomized in a 2:1 allocation to MTPC (n = 92) or LDC (n = 44) in a randomized controlled comparative effectiveness trial. MTPC incorporates mindfulness, self-compassion, and mindfulness-oriented behavior change skills and is delivered as insurance-reimbursable visits within primary care. Participants took part in a chronic disease self-management action planning protocol at week 7. MAIN MEASURES: Level of self-reported action plan initiation on the action plan initiation survey by week 9. KEY RESULTS: Participants randomized to MTPC, relative to LDC, had significantly higher adjusted odds of self-management action plan initiation in an intention-to-treat analysis (OR = 2.28; 95% CI = 1.02 to 5.06, p = 0.025). CONCLUSIONS: An 8-week dose of mindfulness training is more effective than a low-dose mindfulness comparator in facilitating chronic disease self-management behavior change among primary care patients.

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 selfmanagement. Participants schedule 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 selfmanagement 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.