Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches - Admin Supplement

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SUMMARY High impact chronic pain is persistent and limits life and work activities for one in ten adults. Evidence-based cognitive behavioral therapy for chronic pain (CBT-CP) is widely accepted, effective, and does not rely on drugs such as opioids. Most professionals trained in CBT-CP are in urban areas, creating a need for these services in medically underserved and rural areas. Our three-arm comparative effectiveness trial will rigorously evaluate two low-cost, scalable ways to deliver CBT-CP: (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program, and 2) a previously developed and tested 8-session on-line CBT- CP based program (painTRAINER). Comparison will be to usual care augmented with a guide to chronic pain management by the American Chronic Pain Association. Our long-term objective is increasing CBT-CP availability, especially for communities affected by the opioid crisis. This study aims to determine the effectiveness of the telephonic CBT-CP and online program on improving patients’ pain severity (primary outcome) as well as their impact on additional outcomes including quality of life, depression, sleep and long- term opioid use. We will examine patient and system factors that reduce pain severity and the role of theory- based mediators such as catastrophizing and self-efficacy; as well as conduct qualitative evaluations to understand, describe, and explain barriers and facilitators to intervention adoption, implementation and sustainability. The cost and incremental cost-effectiveness of the telephonic CBT-CP and online program will also be assessed compared to each other and usual care. Our population is adults with high impact chronic pain who receive care in one of four diverse healthcare systems. Eligible, consenting participants will be randomized to one of the three study arms. Self-reported pain severity and secondary outcomes will be assessed at baseline and at 3, 6, and 12 months. Regression models for longitudinal data allowing interactions between assessment time and randomization arm will be used to estimate intervention effects at 3 months, the primary endpoint. This project addresses national priorities including identifying effective, low- cost, low-risk care models for pain management, especially behavioral treatments for self-management that can be readily implemented and disseminated. If effective, these remotely delivered CBT-CP programs have the potential to spread nationally, similar to phone interventions for tobacco cessation and weight loss, to reduce the personal and economic burdens of chronic pain.