Background & Aims
Chronic pain is more widespread and severe among United States military veterans compared to civilians.1 Although guidelines now recommend evidence-based non-pharmacologic treatment approaches for chronic pain (NPTs),2 they are underutilized due to numerous interrelated patient-, provider-, and system-level barriers.3-5 Mindfulness-based interventions (MBIs) are evidence-based NPTs for improving chronic pain and comorbid conditions.6,7 However, many MBIs have features that pose significant implementation barriers for healthcare systems and patients.3-5 This randomized pragmatic trial examined two scalable, telehealth MBIs for Veterans with chronic pain, designed to facilitate participant engagement and reduce system barriers. Each MBI addressed essential introductory mindfulness knowledge and skills in regulating attention and emotions, establishing body awareness, and shifting self-perceptions, and goals of scalability within the VA healthcare system.3
Methods
Randomized pragmatic trial of 811 men and women veterans with moderate to severe chronic pain, recruited from 3 VA facilities. Two 8-week MBIs, offered in different formats, were compared to Usual Care (UC). Group MBI was delivered via videoconferencing and consisted of pre-recorded mindfulness education and skill training videos by an experienced mindfulness instructor, with discussions by trained facilitators. Self-paced MBI consisted of the same videos, completed asynchronously on one’s own via a mobile app, supplemented by three individual facilitator calls. The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months (range, 0-10; higher scores = worse function). Secondary outcomes were pain intensity, global improvement in pain, anxiety, depression, post-traumatic stress disorder (PTSD), physical function, fatigue, sleep disturbance, participation in social roles and activities, and a 30% or more improvement in pain functioning.
Results
Among 811 randomized patients (mean age, 54.6 years; 47.7% women; 62.8% with psychiatric diagnosis), 694 (86%) completed the trial. Over 12 months, the Self-paced MBI group had better pain functioning (mean BPI interference = 4.48) than UC (5.05), difference -0.6 [95% CI, -0.9 to -0.2]); the Group MBI (5.05) and UC did not significantly differ (p = 0.15). Over 12 months, the percentage of participants with 30% or more improvement in BPI interference score was significantly greater in the Self-paced MBI (53.8%) and Group MBI (41.0%) compared to UC (31.7%). The Self-paced MBI had greater improvement on all other secondary outcomes compared to UC; the Group MBI had greater improvements than UC for all other outcomes except anxiety.
Conclusions
Two scalable MBIs, delivered via telehealth, significantly reduced pain interference and other pain and biopsychosocial outcomes when compared to usual care over 12 months, among a veteran population with chronic pain and a high prevalence of psychiatric comorbidity. Although the magnitude of between group effects of the interventions were small, they were consistent across a range of biopsychosocial, whole person outcomes that are important to patients, including improved sleep, fatigue and physical function and reduction in symptoms of anxiety, depression, and PTSD, and persisted over 12 months. This suggests that MBIs are a promising piece of more comprehensive multi-modal interventions that could have larger treatment effects. This study addresses recommendations that more trials of NPTs for pain be conducted on populations that experience health disparities in chronic pain, which includes veterans, those with mental illness and those who are socioeconomically disadvantaged.8
References
- Nahin RL. Severe Pain in Veterans: The Effect of Age and Sex, and Comparisons With the General Population. J Pain. Mar 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021
- Qaseem A, Wilt TJ, McLean RM, Forciea MA, Clinical Guidelines Committee of the American College of P. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. Feb 14 2017;doi:10.7326/M16-2367
- Martinez ME, Kearney DJ, Simpson T, Felleman BI, Bernardi N, Sayre G. Challenges to Enrollment and Participation in Mindfulness-Based Stress Reduction Among Veterans: A Qualitative Study. J Altern Complement Med. Jul 2015;21(7):409-21. doi:10.1089/acm.2014.0324
- Demarzo M, Cebolla A, Garcia-Campayo J. The implementation of mindfulness in healthcare systems: a theoretical analysis. General hospital psychiatry. 2015;37(2):166-171.
- Taylor SL, Bolton R, Huynh A, et al. What should health care systems consider when implementing complementary and integrative health: Lessons from Veterans Health Administration. The Journal of Alternative and Complementary Medicine. 2019;25(S1):S52-S60.
- Kligler B, Bair MJ, Banerjea R, et al. Clinical Policy Recommendations from the VHA State-of-the-Art Conference on Non-Pharmacological Approaches to Chronic Musculoskeletal Pain. J Gen Intern Med. May 2018;33(Suppl 1):16-23. doi:10.1007/s11606-018-4323-z
- Goldberg SB, Riordan KM, Sun S, Davidson RJ. The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials. Perspect Psychol Sci. Jan 2022;17(1):108-130. doi:10.1177/1745691620968771
- Relieving. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. National Academy of Sciences; 2011.
Presenting Author
Diana Burgess
Poster Authors
Diana Burgess
PhD
University of Minnesota and Minneapolis Veterans Affairs Healthcare System
Lead Author
Collin Calvert
PhD
University of Minnesota and Minneapolis Veterans Affairs Healthcare System
Lead Author
Kelli Allen
PhD
University of North Carolina at Chapel Hill and Durham VA Health Care System
Lead Author
Ann Bangerter
BS
Minneapolis Veterans Affairs Healthcare System
Lead Author
Mariah Branson
BA
Minneapolis Veterans Affairs Healthcare System
Lead Author
Gert Bronfort
PhD
University of Minnesota
Lead Author
Emily Hagel Campbell
Minneapolis Veterans Affairs Healthcare System
Lead Author
Lee Cross
MPH
Minneapolis Veterans Affairs Healthcare System
Lead Author
Roni Evans
PhD
University of Minnesota
Lead Author
John Ferguson
PhD
University of Minnesota
Lead Author
Jessica Friedman
PhD
VA Greater Los Angeles Health Care System
Lead Author
Alexander Haley
PhD
University of Minnesota
Lead Author
Mallory Mahaffey
MPH
Minneapolis Veterans Affairs Healthcare System
Lead Author
Marianne Matthias
PhD
Roudebush VA Medical Center and Indiana University
Lead Author
Laura Meis
PhD
Minneapolis Veterans Affairs Health Care System and University of Minnesota
Lead Author
Melissa Polusny
PhD
Minneapolis Veterans Affairs Health Care System and University of Minnesota
Lead Author
J. Greg Serpa
PhD
VA Greater Los Angeles Health Care System
Lead Author
Stephanie Taylor
PhD
VA Greater Los Angeles Health Care System
Lead Author
Brent Taylor
PhD
Minneapolis Veterans Affairs Health Care System and University of Minnesota
Lead Author
Topics
- Treatment/Management: Complementary and Alternative therapies