PROJECT SUMMARY/ABSTRACT Mindfulness-Based Stress Reduction (MBSR) is a promising approach to treat major health problems, such as depression, anxiety, and chronic pain. The last extensive MBSR systematic review was for trials (k=101 studies; N= 8,135 participants) available through 2015. It showed a moderate evidence level using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system, with a call for more and higher quality randomized controlled trials. This literature has expanded with hundreds of clinical trials. It is past time to conduct a systematic review and meta-analysis to determine how strong the evidence is. This will inform whether and how MBSR should be included in health insurance coverage to reduce the global burden of disease and to aid development of better MBSR-related treatments. To do so, scientists recommend integrated knowledge translation (iKT), where researchers and knowledge users co-create knowledge. Although iKT has been used in systematic reviews, it has not been used in a mindfulness systematic review. Primary aims are: 1. Perform stakeholder evaluations to identify: (a) Key questions they have to make decisions about if, how, and when MBSR should be covered by health insurance; (b) what is the highest priority evidence they need on MBSR’s effectiveness and cost-effectiveness; (c) barriers that are important to understand and resolve in order for MBSR to be covered by health insurance. 2. Through a systematic review and meta-analysis, determine the impacts of MBSR on key health-related outcomes informed by the iKT strategy in Aim 1b, such as: (a) anxiety, (b) depression, (c) stress, (d) physical functioning, (e) quality of life, (f) pain with related opioid use, and (g) cost effectiveness. 3. Evaluate whether meta-analytic effects differ based on implementation-related factors informed by stakeholders, such as length adherence (e.g., session length), program fidelity (e.g., teacher training, home practice), delivery modality (in-person vs. online), setting and population (e.g., clinical vs. non-clinical), and effect sustainability (e.g., whether benefits last ≥1 year). Aim 1 methods include stakeholder meetings to conduct formative evaluations involving qualitative interviews and a modified Delphi approach. Methods for Aims 2 and 3 will be state-of-the-science systematic evidence syntheses. These will utilize all major databases to identify MBSR trials that address the primary health outcomes; examine the robustness of evidence across both randomized controlled trials and uncontrolled trials (facilitated by a comprehensive behavior change technique taxonomy to characterize active content); and analyze effect sizes following the best standards. Throughout the review process, we will engage stakeholders, guided by the SPIRIT (Supporting Policy In health with Research: an Intervention Trial) Action Framework. Overall, these evidence syntheses will provide evidence that may transform not only the science of MBSR and related treatments but also increase health insurance coverage and access for millions of people

PROJECT NARRATIVE At this time, policy makers and health insurers are actively exploring covering Mindfulness-Based Stress Reduction, but are not equipped with recent evidence syntheses to aid those decisions. These systematic reviews and meta-analyses, done in partnership with knowledge users, will provide the needed evidence for sound decisions and demonstrate knowledge gaps for researchers to fill. Overall, this project will provide evidence syntheses that could transform Mindfulness-Based Stress Reduction health insurance coverage and access for millions of people.