Empowered Relief, cognitive behavioral therapy, and health education for people with chronic pain: a comparison of outcomes at 6-month Follow-up for a randomized controlled trial.

Introduction: We previously conducted a 3-arm randomized trial (263 adults with chronic low back pain) which compared group-based (1) single-session pain relief skills intervention (Empowered Relief; ER); (2) 8-session cognitive behavioral therapy (CBT) for chronic back pain; and (3) single-session health and back pain education class (HE). Results suggested non-inferiority of ER vs. CBT at 3 months post-treatment on an array of outcomes.
Methods: Here, we tested the durability of treatment effects at 6 months post-treatment. We examined group differences in primary and secondary outcomes at 6 months and the degree to which outcomes eroded or improved from 3-month to 6-month within each treatment group.
Results: Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes. Outcome improvements within ER did not decrease significantly from 3-month to 6-month, and indeed ER showed additional 3- to 6-month improvements on pain catastrophizing, pain bothersomeness, and anxiety. Effects of ER at 6 months post-treatment (moderate term outcomes) kept pace with effects reported by participants who underwent 8-session CBT.
Conclusions: The maintenance of these absolute levels implies strong stability of ER effects. Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes.
Competing Interests: Stanford University receives revenue for continuing medical education on Empowered Relief (ER) instructor certification training provided to clinicians. Dr. Darnall is Chief Science Advisor at AppliedVR, and her consulting role with this company (personal fees) is unrelated to the current research. Dr. Darnall receives royalties for 4 pain treatment books she has authored or coauthored. She is the principal investigator for 2 pain research awards from the Patient-Centered Research Outcomes Research Institute, both of which involve either E.R., C.B.T., or both. Dr. Darnall is principal investigator for 2 NIH grants that are investigating the efficacy of E.R. Dr. Darnall serves on the Board of Directors for the American Academy of Pain Medicine, the Board of Directors for the Institute for Brain Potential, and the Medical Advisory Board for the Facial Pain Association. Dr. Darnall is a scientific member of the NIH Interagency Pain Research Coordinating Committee, a former member of the Centers for Disease Control and Prevention Opioid Workgroup (2020–2021), and a current member of the Pain Advisory Group of the American Psychological Association. Dr. Mackey receives research funding from the NIH, Food and Drug Administration, and Patient-Centered Outcomes Research Institute (administered through Stanford University). He is an unpaid advisor to both ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) on their oversight committee, and the American Chronic Pain Association (ACPA) for their scientific oversight. All other authors report no disclosures or conflicts of interest.
(Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.)