Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain.

This paper describes the protocol for a four-site, three-arm pragmatic randomized controlled trial called Learning to Apply Mindfulness to Pain (LAMP), which will test two delivery methods of mindfulness-based interventions (MBIs) for Veterans with chronic pain and mental health comorbidities. The two interventions are Mobile+Group LAMP, which combines prerecorded mindfulness modules with online group discussions, and Mobile LAMP, which uses only the prerecorded modules without a group component. The trial will compare each intervention against usual care, measuring pain interference at 10 weeks, 6 months, and 12 months, and will also examine secondary outcomes like PTSD and depression, including gender-specific analyses.

Study at a glance

Abstract

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 prerecorded modules presented by a mindfulness 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, 6 months, and 12 months. 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.