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Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

Publication ,  Journal Article
Mayhew, M; Balderson, BH; Cook, AJ; Dickerson, JF; Elder, CR; Firemark, AJ; Haller, IV; Justice, M; Keefe, FJ; McMullen, CK; Owen-Smith, AA ...
Published in: Trials
March 16, 2023

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.

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Published In

Trials

DOI

EISSN

1745-6215

Publication Date

March 16, 2023

Volume

24

Issue

1

Start / End Page

196

Location

England

Related Subject Headings

  • Telemedicine
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Humans
  • General & Internal Medicine
  • Cost-Benefit Analysis
  • Cognitive Behavioral Therapy
  • Chronic Pain
  • Cardiovascular System & Hematology
  • 4203 Health services and systems
 

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Mayhew, M., Balderson, B. H., Cook, A. J., Dickerson, J. F., Elder, C. R., Firemark, A. J., … DeBar, L. L. (2023). Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Trials, 24(1), 196. https://doi.org/10.1186/s13063-023-07165-8
Mayhew, Meghan, Benjamin H. Balderson, Andrea J. Cook, John F. Dickerson, Charles R. Elder, Alison J. Firemark, Irina V. Haller, et al. “Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.Trials 24, no. 1 (March 16, 2023): 196. https://doi.org/10.1186/s13063-023-07165-8.
Mayhew M, Balderson BH, Cook AJ, Dickerson JF, Elder CR, Firemark AJ, Haller IV, Justice M, Keefe FJ, McMullen CK, O’Keeffe-Rosetti MC, Owen-Smith AA, Rini C, Schneider JL, Von Korff M, Wandner LD, DeBar LL. Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Trials. 2023 Mar 16;24(1):196.
Journal cover image

Published In

Trials

DOI

EISSN

1745-6215

Publication Date

March 16, 2023

Volume

24

Issue

1

Start / End Page

196

Location

England

Related Subject Headings

  • Telemedicine
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Humans
  • General & Internal Medicine
  • Cost-Benefit Analysis
  • Cognitive Behavioral Therapy
  • Chronic Pain
  • Cardiovascular System & Hematology
  • 4203 Health services and systems