Diana J Burgess1,2, Roni Evans3,4, Kelli D Allen5,6, Ann Bangerter1, Gert Bronfort3,4, Lee J Cross1, John E Ferguson2,7, Alex Haley3,4, Emily M Hagel Campbell1, Mallory R Mahaffey1, Marianne S Matthias8,9,10, Laura A Meis1,2, Melissa A Polusny1,2, J Greg Serpa11,12, Stephanie L Taylor12,13, Brent C Taylor1,2. 1. VA HSR&D Center for Care Delivery and Outcomes Research, VA Medical Center, Minneapolis, USA. 2. University of Minnesota Medical School. 3. Integrative Health & Wellbeing Research Program, Center for Spirituality & Healing. 4. School of Nursing, University of Minnesota. 5. Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System. 6. Thurston Arthritis Research Center, University of North Carolina at Chapel Hill. 7. Minneapolis VA Medical Center. 8. Center for Health Information and Communication, Roudebush VA Medical Center. 9. Regenstrief Institute. 10. Indiana University School of Medicine. 11. Greater Los Angeles VA Healthcare System, Los Angeles, California, USA. 12. Center for the Study of Healthcare Innovation, Implementation and Policy, Greater Los Angeles VA Healthcare System, Los Angeles, California, USA. 13. Department of Health Policy and Management, UCLA School of Public Health and UCLA School of Medicine, Los Angeles, California, USA.
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. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. This work is written by US Government employees and is in the public domain in the US.
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. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. This work is written by US Government employees and is in the public domain in the US.
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