Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial.
Francis J Keefe, Sarah J Schrauben, Nwamaka D Eneanya, Sahir Kalim, Manisha Jhamb, Jennifer L Steel, Michael J Fischer, Laura M Dember, Kerri L Cavanaugh, Paul L Kimmel, Sagar U Nigwekar, Mark L Unruh, Rebecca J Schmidt, David M Charytan, Benjamin J Morasco, Mansi Mehta, Jeffrey Penfield, Daniel Cukor, Natalie Kuzla, Bethany Pellegrino, David M White, Ardith Z Doorenbos, William C Becker, Martin D Cheatle, Alicia A Heapy, Erin E Krebs, Leah Bernardo, Carrie E Brintz, James B Wetmore, Patrick H Pun, Kirsten L Johansen, Nobuyuki Miyawaki, Jesse Y Hsu, Rajnish Mehrotra
Journal: JAMA internal medicine
2025;185(2):197-207
PMID: 39786400
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.
Address:
Renal-Electrolyte and Hypertension Division, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia.; Department of Biostatistics, Epidemiology and Informatics, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia.; Department of Biostatistics, Epidemiology and Informatics, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia.; Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle.; Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.; Division of Nephrology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston.; Division of Nephrology, Department of Medicine, New York University Grossman School of Medicine, New York, New York.; Department of Internal Medicine, University of Illinois Hospital and Health Sciences Center, Chicago.; Medical Service, Jesse Brown VA Medical Center, Chicago, Illinois.; Center of Innovation for Complex Chronic Healthcare, Edward Hines, Jr. VA Hospital, Hines, Illinois.; Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.; Division of Nephrology, Department of Medicine, Hennepin Healthcare, Minneapolis, Minnesota.; Department of Medicine, University of Minnesota Medical School, Minneapolis.; Section of General Internal Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut.; Pain Research, Informatics, Multi-morbidities and Education Center of Innovation, VA Connecticut Healthcare System, West Haven.; Division of Nephrology, Department of Medicine, West Virginia University School of Medicine, Morgantown.; Renal-Electrolyte and Hypertension Division, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia.; Now with Division of Renal Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.; Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.; Medical Service, Durham VA Medical Center, Durham, North Carolina.; Division of Nephrology, Department of Internal Medicine, School of Medicine, University of New Mexico, Albuquerque.; Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon.; Department of Psychiatry, Oregon Health & Science University, Portland.; Division of Nephrology, Department of Medicine, New York University Grossman School of Medicine, New York, New York.; VA New York Harbor Healthcare, New York.; Division of Nephrology, New York University Grossman Long Island School of Medicine, Mineola, New York.; The University of Texas Southwestern Medical Center, Dallas.; VA North Texas Health Care System, Dallas.; Division of Pain Medicine, Department of Anesthesiology, Vanderbilt Center for Musculoskeletal Research, Osher Center for Integrative Health at Vanderbilt, Vanderbilt University Medical Center, Nashville, Tennessee.; Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia.; Department of Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia.; Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois Chicago, Chicago.; Department of Anesthesiology and Pain Medicine, University of Washington, Seattle.; Pain Research, Informatics, Multi-morbidities and Education Center of Innovation, VA Connecticut Healthcare System, West Haven.; Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.; Pain Prevention and Treatment Research Program, Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.; Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.; Division of General Internal Medicine, University of Minnesota Medical School, Minneapolis.; Clinical Research Collaboration Unit, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.; Division of Hepatobiliary Surgery, Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.; Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.; Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.; American Association of Kidney Patients, Tampa, Florida.; National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.; The Rogosin Institute, New York, New York.; Now with Division of Nephrology, Department of Medicine, New York University Grossman School of Medicine, New York.
Link outs
Free resources
Full Text Sources:
Medical:
Subscription / membership required
MeSH Terms:
Aged,
Female,
Humans,
Male,
Middle Aged,
Adaptation, Psychological,
Chronic Pain,
Cognitive Behavioral Therapy,
Coping Skills,
Kidney Failure, Chronic,
Pain Management,
Pain Measurement,
Quality of Life,
Renal Dialysis
