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Clinical Trial
. 2025 Feb 1;185(2):197-207.
doi: 10.1001/jamainternmed.2024.7140.

Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial

Laura M Dember  1   2 , Jesse Y Hsu  2 , Rajnish Mehrotra  3 , Kerri L Cavanaugh  4 , Sahir Kalim  5 , David M Charytan  6 , Michael J Fischer  7   8   9 , Manisha Jhamb  10 , Kirsten L Johansen  11   12 , William C Becker  13   14 , Bethany Pellegrino  15 , Nwamaka D Eneanya  1   16 , Sarah J Schrauben  1   2 , Patrick H Pun  17   18 , Mark L Unruh  19 , Benjamin J Morasco  20   21 , Mansi Mehta  6   22 , Nobuyuki Miyawaki  23 , Jeffrey Penfield  24   25 , Leah Bernardo  2 , Carrie E Brintz  26 , Martin D Cheatle  27   28 , Ardith Z Doorenbos  29   30 , Alicia A Heapy  14   31 , Francis J Keefe  32 , Erin E Krebs  33   34 , Natalie Kuzla  35 , Sagar U Nigwekar  5 , Rebecca J Schmidt  15 , Jennifer L Steel  36   37   38 , James B Wetmore  11   12 , David M White  39 , Paul L Kimmel  40 , Daniel Cukor  41   42 ; HOPE Consortium
Collaborators, Affiliations
Clinical Trial

Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial

Laura M Dember et al. JAMA Intern Med. .

Erratum in

Abstract

Importance: Chronic pain is common among individuals with dialysis-dependent kidney failure.

Objective: To evaluate the effectiveness of pain coping skills training (PCST), a cognitive behavioral intervention, on pain interference.

Design, setting, and participants: This multicenter randomized clinical trial of PCST vs usual care was conducted across 16 academic centers and 103 outpatient dialysis facilities in the US. Adults undergoing maintenance hemodialysis and experiencing chronic pain were randomly assigned to PCST or usual care in a 1:1 ratio. Participants were followed in the trial for 36 weeks. Enrollment began on January 4, 2021, and follow-up ended on December 21, 2023.

Interventions: PCST consisting of 12 weekly coach-led sessions via video or telephone conferencing, followed by 12 weeks of daily interactive voice response sessions. Usual care had no trial-driven pain intervention.

Main outcomes: The primary outcome was pain interference measured with the Brief Pain Inventory (BPI) Interference subscale (score range of 0-10, with higher scores indicating more pain interference). Secondary outcomes included pain intensity, pain catastrophizing, quality of life, depression, and anxiety.

Results: A total of 643 participants (mean [SD] age, 60.3 [12.6] years; 288 [44.8%] female) were randomized, with 319 assigned to PCST and 324 assigned to usual care. At week 12 (primary end point), the PCST group had a larger reduction in the BPI Interference score than the usual care group (between-group difference, -0.49; 95% CI, -0.85 to -0.12; P = .009). The effect persisted at week 24 (between-group difference in BPI Interference score, -0.48; 95% CI, -0.86 to -0.11) but was diminished at week 36 (between-group difference in BPI Interference score, -0.34; 95% CI, -0.72 to 0.04). A decrease in BPI Interference score greater than 1 point (minimal clinically important difference) occurred in 143 of 281 participants (50.9%) in the PCST group vs 108 of 295 participants (36.6%) in the usual care group at 12 weeks (odds ratio, 1.79; 95% CI, 1.28-2.49) and 142 of 258 participants (55.0%) in the PCST group vs 113 of 264 participants (42.8%) in the usual care group at 24 weeks (odds ratio, 1.59; 95% CI, 1.13-2.24). Favorable changes with PCST were also apparent for secondary outcomes of pain intensity, quality of life, depression, and anxiety at weeks 12 and/or 24, as well as for pain catastrophizing at weeks 24 and 36.

Conclusions and relevance: In this randomized clinical trial of patients undergoing maintenance hemodialysis, PCST had benefits on pain interference and other pain-associated outcomes. While the effect on the overall cohort was of modest magnitude, the intervention resulted in a clinically meaningful improvement in pain interference for a substantial proportion of participants.

Trial registration: ClinicalTrials.gov Identifier: NCT04571619.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Dember reported personal fees from National Kidney Foundation, AstraZeneca, Merck, Alucent Biomedical, Vertex, CSL Behring, and NIDDK outside the submitted work. Dr Hsu reported personal fees from National Kidney Foundation, Public Library of Science, and American Medical Association. Dr Charytan reported grants from Eli Lilly/Boehringer Ingelheim and Medtronic, as well as personal fees from Novo Nordisk, GSK, AstraZeneca, CSL Behring, and Merck outside the submitted work. Dr Jhamb reported grants from Dialysis Clinic Inc, Pfizer, Bayer, and CKD Networks of Excellence, as well as personal fees from Xcenda, Boehringer Ingelheim, and Eli Lilly outside the submitted work. Dr Johansen reported personal fees from GSK, Akebia, Vifor, and American Society of Nephrology outside the submitted work. Dr Eneanya reported personal fees from Fresenius Medical Care and DaVita outside the submitted work. Dr Pun reported grants from Medtronic outside the submitted work. Dr Brintz reported personal fees from Academic Consortium for Integrative Medicine and Health and US Department of Defense outside the submitted work. Dr Heapy reported grants from Yale School of Medicine during the conduct of the study and grants from US Department of Veterans Affairs outside the submitted work. Dr Keefe reported grants from Duke University during the conduct of the study. Dr Krebs reported grants paid to her institution from US Department of Veterans Affairs, Patient-Centered Outcomes Research Institute, and National Center For Complementary and Alternative Medicine; support for effort as associate editor for Patient-Centered Outcomes Research Institute reports paid to her institution; travel expenses from American College of Physicians, Foundation for Opioid Response Efforts, and US Association for the Study of Pain; and serving as an unpaid member of Foundation for Opioid Response Efforts scientific advisory council and chair or member of data safety monitoring boards for US Department of Veterans Affairs, National Institutes of Health, and Patient-Centered Outcomes Research Institute studies, all outside the submitted work. Dr Nigwekar reported personal fees from CSL Behring and Fresenius Medical Care North America outside the submitted work. Dr Kimmel reported royalties from Elsevier and a press advance from Mayo Clinic outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram of Participant Enrollment and Follow-Up
Reasons for ineligibility among the 38 patients who consented but were subsequently found to be not eligible include hemodialysis for fewer than 90 days (n = 6); not meeting criteria for chronic pain (n = 5); Pain, Enjoyment of Life, and General Activity scale score lower than 4 (n = 3); current opioid or other nontobacco substance use disorder (n = 8); substantial cognitive impairment (n = 3); life expectancy shorter than 6 months (n = 2); unstable psychiatric disorder (n = 2); expected kidney transplant, dialysis unit transfer, or transfer to home dialysis (n = 3); not allowing access to opioid prescription data (n = 1), and other condition precluding participation (n = 5). BPI indicates Brief Pain Inventory.
Figure 2.
Figure 2.. Effects of Pain Coping Skills Training (PCST) on Primary and Secondary Patient-Reported Outcomes
For quality of life (QOL), a higher score indicates better outcome; for all other measures, a higher score indicates worse outcome. Error bars represent 95% CIs. BPI indicates Brief Pain Inventory; GAD-7, 7-item generalized anxiety disorder; PCS SF-6, Pain Catastrophizing Scale 6-item short form; PHQ-9, 9-item Patient Health Questionnaire for depression.
See this image and copyright information in PMC

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