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BackgroundWhile mindfulness-based interventions (MBIs) employ two distinct practices, focused attention (FA) and open monitoring (OM), the integrated delivery of these practices in MBIs precludes understanding of their practice-specific effects or mechanisms of action. The purpose of this study is to isolate hypothesized active ingredients and practice-specific mechanistic target engagement by creating structurally equivalent interventions that differ only by the active ingredient (meditation practice) offered and to test whether the hypothesized components differentially engage the mechanistic targets that they are purported to engage. Methods Participants were intended to be representative of American meditators and had mild to severe affective disturbances. Measures of structural equivalence included participant-level (sample characteristics), treatment-level (program structure and duration, program materials, class size, attendance, homework compliance, etc.), and instructor-level variables (training, ratings and adherence/fidelity). Measures of differential validity included analysis of program materials and verification of differential mechanistic target engagement (cognitive and affective skills and beliefs about meditation acquired by participants after the 8-week training). Results The results indicate successful creation of structurally equivalent FA and OM programs that were matched on participant-level, treatment-level, and instructor-level variables. The interventions also differed as expected with respect to program materials as well as mechanistic targets engaged (skills and beliefs acquired). Conclusions These validated 8-week FA and OM training programs can be applied in future research to assess practice-specific effects of meditation.
BackgroundSelf-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.