R01AT011745

Mindfulness-Based Stress Reduction: An Implementation Science-Informed Systematic Review and Meta-Analysis - Project Summary/Abstract

Mindfulness-Based Stress Reduction (MBSR) is a promising approach to treating major health problems such as depression, anxiety, and chronic pain. The last extensive systematic review of MBSR was conducted for trials available through 2015, which included 101 studies and 8,135 participants. This review showed a moderate level of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system, but called for more high-quality randomized controlled trials. Since then, the literature on MBSR has expanded with hundreds of clinical trials, making it necessary to conduct a new systematic review and meta-analysis to determine the strength of the evidence. This will inform whether and how MBSR should be included in health insurance coverage to reduce the global burden of disease and aid in the development of better MBSR-related treatments.

To achieve this, scientists recommend using Integrated Knowledge Translation (IKT), where researchers and knowledge users collaborate to create knowledge. While IKT has been used in systematic reviews, it has not been applied to a mindfulness systematic review. The primary aims of this project are as follows:

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. The highest priority evidence they need on MBSR's effectiveness and cost-effectiveness.
c. Barriers that are important to understand and resolve 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
g. Cost-effectiveness

3. Evaluate whether meta-analytic effects differ based on implementation-related factors informed by stakeholders, such as:
a. Length adherence (e.g., session length)
b. Program fidelity (e.g., teacher training, home practice)
c. Delivery modality (in-person vs. online)
d. Setting and population (e.g., clinical vs. non-clinical, specific genders and racial/ethnic groups)
e. Effect sustainability (e.g., whether benefits last for more than one year)

The methods for Aim 1 include stakeholder meetings to conduct formative evaluations involving qualitative interviews and a modified Delphi approach. The methods for Aims 2 and 3 will involve state-of-the-science systematic evidence syntheses. These syntheses 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, stakeholders will be engaged, guided by the SPIRIT (Supporting Policy in Health with Research: An Intervention Trial) action framework.

Overall, these evidence syntheses will provide valuable insights that may transform not only the science of MBSR and related treatments but also increase health insurance coverage and access for millions of people.

Brown University

NOT APPLICABLE

93.213 - Research and Training in Complementary and Integrative Health

National Center for Complementary and Integrative Health (NCCIH) [HHS - NIH]

Providence, Rhode Island 029032905 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the total obligations have increased 368% from $689,474 to $3,227,284.