Center for Care Delivery and Outcomes Research
MARVEL (Mindfulness Approaches to Reduce Veterans Pain and Enhance Life)
Anticipated Impacts on Veterans Health Care.
This study will test two approaches for delivering non-pharmacological chronic pain treatment, aimed at optimizing adherence, access and reach. It has the potential to increase the impact of evidence-based non-pharmacological treatment on Veterans who suffer from chronic pain.
There is a pressing need to provide effective, non-pharmacological treatment to the vast number of Veterans with chronic musculoskeletal pain. Mindfulness-Based Interventions (MBIs) are one such approach shown to be effective for treating chronic pain and comorbid conditions (e.g., PTSD, insomnia, depression, and substance abuse). However, the predominant MBI offered in the Veterans Health Administration (VHA) and other health care systems, Mindfulness-Based Stress Reduction (MBSR), has features that pose significant implementation barriers, at the patient- and organizational-levels.
The long term goal of this project is to reduce chronic musculoskeletal (MSK) pain and co-morbid conditions among Veterans, through scalable, non-pharmacologic evidence-based strategies that are “Veteran-Centric,” designed to optimize engagement, adherence and sustainability, and are deliverable to large numbers of Veterans. Phase 1 of this project (UG3) consists of preparatory activities to lay the groundwork for a multisite randomized clinical trial (RCT) to be conducted in Phase 2 (UH3), to test the effectiveness of two MBIs (Mobile+Group and Mobile MBIs) at improving outcomes related to pain and mental health comorbidities. Mobile+Group MBI consists of pre-recorded modules presented by a trained mindfulness instructor that are viewed in face-to-face group settings and interspersed with discussions led by a facilitator (who is not required to be an expert in mindfulness). The Mobile MBI consists only of the same training and practice modules. Inclusion of this delivery method allows for rigorous testing of the addition of the in-person, group component of the MBI.
A 4-site 3-arm RCT (N = 750) will test the effectiveness of Mobile+Group and Mobile MBIs compared to usual practice for men and women and address key implementation research questions. Effectiveness will be assessed by pain response and improved functioning at 6 months from baseline, defined as a 30% improvement in our co-primary outcomes (Brief Pain Inventory total score; modified Roland Disability Questionnaire). Outcomes also will be assessed directly after the intervention, at 3 months, and at 12 months. Study design will be stratified and balanced by gender to examine the effectiveness of the intervention separately by gender. Data analysis of primary aims will follow intention to treat methodology. Secondary outcomes will include measures captured in health care records (e.g., medication prescription/refills, health care visits for pain management) as well as patient-reported measures related to pain, co-morbid mental health conditions and function. Patient characteristics that may predict treatment response will also be explored. Implementation data will be collected and described, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, using a multi-stakeholder, mixed methods process evaluation.