Background. Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain. However, the predominant MBI, mindfulness-based stress reduction, has features that pose significant implementation barriers. Objectives. This study will test two approaches to delivering MBIs for improving Veterans' chronic pain and mental health comorbidities. These two approaches address key implementation barriers. Methods. We will conduct a four-site, three-arm pragmatic randomized controlled trial, Learning to Apply Mindfulness to Pain (LAMP), to test the effectiveness of two MBIs at improving pain and mental health comorbidities. Mobile Group LAMP consists of prerecordedmodules presented by amindfulness instructor that are viewed in an online group setting and interspersed with discussions led by a facilitator. Mobile LAMP consists of the same prerecorded modules but does not include a group component. We will test whether either of these MBIs will be more effective than usual care at improving chronic pain and whether the Mobile Group LAMP will be more effective than Mobile LAMP at improving chronic pain. Comparisons for the primary hypotheses will be conducted with continuous outcomes (Brief Pain Inventory interference score) repeated at 10 weeks, 6months, and 12months. The secondary hypotheses are that Mobile Group LAMP and Mobile LAMP will be more effective than usual care at improving secondary outcomes (e.g., post-traumatic stress disorder, depression). We will also confirm the comparisons for the primary and secondary hypotheses in gender-specific strata. Implications. This trial is expected to result in two approaches for delivering MBIs that will optimize engagement, adherence, and sustainability and be able to reach large numbers of Veterans.
Bibliographical noteFunding Information:
Funding: The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702–5014, is the awarding and administering acquisition office. This work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory–Pragmatic Clinical Trials Demonstration Projects under Award No. W81XWH-18–2-0003. Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the Department of Defense. Research reported in this publication was supported by the National Center for Complementary and Integrative Health of the National Institutes of Health under Award Number U24AT009769. This material is the result of work supported with resources and the use of facilities at the Minneapolis VA Medical Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This manuscript is a product of the NIH-DOD-VA Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org/.
Supplement sponsorship: This article appears as part of the supplement entitled “NIH-DOD-VA Pain Management Collaboratory (PMC)”. This supplement was made possible by Grant Number U24 AT009769 from the National Center for Complementary and Integrative Health (NCCIH), and the Office of Behavioral and Social Sciences Research (OBSSR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCCIH, OBSSR, and the National Institutes of Health.
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- Chronic pain