Abstract
Background: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. Methods: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. Discussion: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. Trial registration: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.
| Original language | English (US) |
|---|---|
| Article number | 196 |
| Journal | Trials |
| Volume | 24 |
| Issue number | 1 |
| DOIs | |
| State | Published - Dec 2023 |
Funding
This research is supported by the National Institutes of Health through the NIH HEAL Initiative, National Institute on Aging (NIA), P.O. Box 8057, Gaithersburg, MD 20898 [UH3AG067493, PI: DeBar]. Research reported in this publication was also supported by the National Center for Advancing Translational Sciences, Trial Innovation Network under award number U24TR001597 (Clinical Coordinating Center), U24TR001608 (Data Coordinating Center), U24TR001609 (Recruitment Innovation Center), and U24TR001579 (Safety and Statistical Coordinating Center). The authors thank our study team of project managers, recruitment staff, assessors, analysts, and health coaches at the KPGA, KPNW, KPWA, and Essentia sites. We also acknowledge Susan Shortreed, PhD, and David Smith, PhD, for their contributions to the study proposal. The authors also thank Jennifer L. Murphy, PhD for serving as a consultant to the study and providing training and fidelity monitoring for the health coaches. Lastly, the authors appreciate the support and collaboration from our colleagues at the Trial Innovation Centers at the Duke Clinical Research Institute, University of Utah, and Johns Hopkins University and the Recruitment Innovation Center at Vanderbilt University Medical Center. Participants are being recruited from the populations of 4 integrated healthcare systems which serve as the clinical sites: (1) Kaiser Permanente Georgia (KPGA) with a service area of northern Georgia, (2) Kaiser Permanente Northwest (KPNW) with a service area of Oregon and southwest Washington, (3) Kaiser Permanente Washington (KPWA) with a service area of Washington state, and (4) Essentia Health with services throughout areas of northern Minnesota, eastern North Dakota, and northern Wisconsin. The healthcare facilities in the 3 participating KP regions are located in urban and suburban areas; however, the KP healthcare systems also serve individuals residing in rural areas of their respective regions. Essentia primarily serves rural areas. The RESOLVE study is part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) Initiative which is an aggressive, trans-NIH effort focused on improving prevention and treatment strategies for opioid misuse and addiction and enhancing pain management. RESOLVE is supported by the HEAL Pain Effectiveness Research Network which is administered by the National Center for Advancing Translational Science (NCATS) Trial Innovation Network [].
Keywords
- Chronic pain
- Cognitive behavioral therapy
- Nonpharmacologic treatment
- Pragmatic trial
- Telehealth
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)