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,
specific genders and racial/ethnic groups), 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.
