Rajnish Mehrotra, MD, MS; Daniel Cukor, PhD; Mark Unruh, MD, MS; Tessa Rue, MS; Patrick Heagerty, MS, PhD; Scott D. Cohen, MD, MPH; Laura M. Dember, MD; Yaminette Diaz-Linhart, MSW, MPH; Amelia Dubovsky, MD; Tom Greene, PhD; Nancy Grote, MSW, MEd, PhD; Nancy Kutner, PhD; Madhukar H. Trivedi, MD; Davin K. Quinn, MD; Nisha ver Halen, PhD; Steven D. Weisbord, MD, MSc; Bessie A. Young, MD, MPH; Paul L. Kimmel, MD; S. Susan Hedayati, MD, MSc
Disclaimer: The Departments of Veterans Affairs and Health and Human Services do not endorse any of the statements or opinions advocated by this manuscript.
Acknowledgment: For his contributions toward designing this proposal, the authors acknowledge the late Dr. Wayne Katon, who passed away shortly after it was funded. The authors thank all the patients who participated in the ASCEND study as well as the dialysis providers who allowed access to their facilities for the study (DaVita, Dialysis Clinic Inc., Fresenius Medical Care, Northwest Kidney Centers, Puget Sound Kidney Centers, and Olympic Peninsula Kidney Centers). The authors also thank the members of the data safety monitoring board (Alan Kliger, New Haven, Connecticut; Michael Hollified, Long Beach, California; J. Richard Landis, Philadelphia, Pennsylvania; Michael Rocco, Winston-Salem, North Carolina; and Suzanne Watnick, Seattle, Washington), the members of the patient council (Lori Hartwell [chair], Monica Alfonzo, Richard Blaine, Diana Headlee, Linda Oakford, Heather Powell, Glenda Roberts, Nancy Spaeth, and Cal Sturdivant), and the organizations represented on the stakeholder council (American Association of Kidney Patients; Dialysis Patient Citizens; DaVita; Northwest Kidney Centers; Renal Ventures; National Institute of Diabetes, Digestive, and Kidney Diseases; American Nephrology Nurses Association; Council of Nephrology Social Workers; National Renal Administrators Association; and clinicians Gregory Braden, Arti Gupta, Fred Finkelstein, and Lewis Cohen). They also thank the research team members at each clinical site: Albuquerque (Talaya Martinez, Hugo Vilchis, and Alicia Stevens), Dallas (Patricia Alvarez, Aisha Madden, Francisco Sanchez, Kyle West, Joseph Trombello, and L. Parker Gregg), and Seattle (Lori Linke, Kristen O'Loughlin, Carlyn Clark, and Molly Klekamp).
Financial Support: This trial was funded by contract CER-1310-07253 from the Patient-Centered Outcomes Research Institute. Additional support was provided by Dialysis Clinic Inc. (Nashville, Tennessee); the Kidney Research Institute at the University of Washington, Seattle; and grant R01DK085512 from the National Institute of Diabetes and Digestive and Kidney Diseases (to Dr. Hedayati). Dr. Young is supported in part by funding from the Veterans Affairs Puget Sound Healthcare System.
Disclosures: Ms. Diaz-Linhart reports personal fees from the University of Washington during the conduct of the study. Dr. Greene reports grants from the National Institutes of Health during the conduct of the study and personal fees from Janssen Pharmaceuticals, Durect Corporation, and Pfizer and grants from AstraZeneca outside the submitted work. Dr. Trivedi reports personal fees from AcademyHealth, Acadia Pharmaceuticals, Alkermes, Akili Interactive, Allergan, Axsome Therapeutics, Boehringer Ingelheim, Healthcare Global Village, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Lundbeck Research USA, Medscape, Navitor, Otsuka America Pharmaceutical, Oxford Pharmagenesis, and Sage Therapeutics, and grants from the National Institute of Mental Health, National Institute on Drug Abuse, Cancer Prevention Research Institute of Texas, and Janssen Pharmaceuticals, outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2229.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Data Sharing Statement: The following data will be made available beginning 1 January 2020 and ending 3 December 2021: deidentified participant data and participant data with identifiers (contact Rajnish Mehrotra; e-mail, firstname.lastname@example.org). The following supporting documents will be made available beginning 1 January 2020 and ending 31 December 2021: informed consent form (contact Rajnish Mehrotra; e-mail, email@example.com). These data will be made available to investigators with a methodologically sound proposal, with institutional review board approval and demonstration of resources to be able to undertake the proposed analyses, for a wide range of purposes subject to review and approval by the study's publication committee, with support of the principal investigator, and after approval of the proposal, consistent with guidelines of the University of Washington.
Corresponding Author: Rajnish Mehrotra, MD, MS, Kidney Research Institute and Harborview Medical Center, University of Washington, 325 Ninth Avenue, Box 359606, Seattle, WA 98104; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Mehrotra: Kidney Research Institute and Harborview Medical Center, University of Washington, 325 Ninth Avenue, Box 359606, Seattle, WA 98104.
Dr. Cukor: The Rogosin Institute, 505 East 70th Street, New York, NY 10021.
Dr. Unruh: University of New Mexico School of Medicine, MSC 10-5550, 1 University of New Mexico, Albuquerque, NM 87131.
Ms. Rue: Department of Biostatistics, University of Washington, UW Box 359461, 4333 Brooklyn Avenue Northeast, Floor 15, Seattle, WA 98195.
Dr. Heagarty: Department of Biostatistics, Box 357232, University of Washington, Seattle WA 98195.
Dr. Cohen: Division of Renal Diseases and Hypertension, George Washington University, 2150 Pennsylvania Avenue Northwest, Suite 3-438, Washington, DC 20037.
Dr. Dember: Renal, Electrolyte and Hypertension Division, University of Pennsylvania, 920 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.
Ms. Diaz-Linhart: Brandeis University, The Heller School for Social Policy and Management, 415 South Street, Waltham, MA 02453.
Dr. Dubovsky: Harborview Medical Center, 325 9th Avenue, Box 359896, Seattle, WA 98104.
Dr. Greene: Departments of Internal Medicine and Population Health Sciences, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108.
Dr. Grote: University of Washington School of Social Work, 4101 15th Avenue Northeast, #103, Seattle, WA 98105.
Dr. Kutner: Department of Rehabilitation Medicine, Emory University School of Medicine, 1441 Clifton Road Northeast, Atlanta GA 30322.
Dr. Trivedi: Center for Depression Research and Clinical Care, Department of Psychiatry, University of Texas Southwestern, 6363 Forest Park Road, Suite BL13.100, MC 9119, Dallas, TX 75235.
Dr. Quinn: 105 Rim Road, Santa Fe, NM 87501.
Dr. ver Halen: Weill Cornell Medical College, Integrative Health and Wellbeing, 436 East 69th Street, New York, NY 10065.
Dr. Weisbord: 7 East Room 120, 111F-U, VA Pittsburgh Healthcare System, Pittsburgh, PA 15240.
Dr. Young: VA Nephrology, VA Puget Sound Health Care System, 1660 South Columbian Way, RDU 111A, Seattle, WA 98108.
Dr. Kimmel: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 6707 Democracy Boulevard, Bethesda MD 20892.
Dr. Hedayati: Division of Nephrology, Department of Medicine, University of Texas Southwestern, 5939 Harry Hines Boulevard, HP5.500, MC 8516, Dallas, TX 75390.
Author Contributions: Conception and design: R. Mehrotra, D. Cukor, M. Unruh, P. Heagerty, S.D. Cohen, L.M. Dember, Y. Diaz-Linhart, T. Greene, N. Grote, N. Kutner, M.H. Trivedi, D.K. Quinn, S.D. Weisbord, P.L. Kimmel, S.S. Hedayati.
Analysis and interpretation of the data: R. Mehrotra, D. Cukor, M. Unruh, T. Rue, P. Heagerty, L.M. Dember, Y. Diaz-Linhart, N. Kutner, M.H. Trivedi, S.D. Weisbord, P.L. Kimmel, S.S. Hedayati.
Drafting of the article: R. Mehrotra, D. Cukor, M. Unruh, P. Heagerty, Y. Diaz-Linhart, A. Dubovsky, S.D. Weisbord, P.L. Kimmel, S.S. Hedayati.
Critical revision for important intellectual content: R. Mehrotra, D. Cukor, M. Unruh, T. Rue, P. Heagerty, S.D. Cohen, L.M. Dember, A. Dubovsky, T. Greene, N. Grote, N. Kutner, M.H. Trivedi, D.K. Quinn, N. ver Halen, B.A. Young, P.L. Kimmel, S.S. Hedayati.
Final approval of the article: R. Mehrotra, D. Cukor, M. Unruh, T. Rue, P. Heagerty, S.D. Cohen, L.M. Dember, Y. Diaz-Linhart, A. Dubovsky, T. Greene, N. Grote, N. Kutner, M.H. Trivedi, D.K. Quinn, N. ver Halen, S.D. Weisbord, B.A. Young, P.L. Kimmel, S.S. Hedayati.
Provision of study materials or patients: R. Mehrotra, D. Cukor, M. Unruh, N. Grote, M.H. Trivedi, S.S Hedayati.
Statistical expertise: T. Rue, P. Heagerty, T. Greene.
Obtaining of funding: R. Mehrotra, D. Cukor, M. Unruh, P. Heagerty, M.H. Trivedi.
Administrative, technical, or logistic support: R. Mehrotra, M. Unruh, A. Dubovsky, D.K. Quinn, N. ver Halen.
Collection and assembly of data: D. Cukor, M. Unruh, T. Rue, P. Heagerty, A. Dubovsky, M.H. Trivedi, N. ver Halen, S.S. Hedayati.
Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited.
To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis.
Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343)
41 dialysis facilities in 3 U.S. metropolitan areas.
Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2.
Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2).
The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms–Clinician-Rated (QIDS-C) at 12 weeks.
The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, −12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, −1.84 [CI, −3.54 to −0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group.
No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed.
An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT.
Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.
Mehrotra R, Cukor D, Unruh M, Rue T, Heagerty P, Cohen SD, et al. Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial. Ann Intern Med. [Epub ahead of print 26 February 2019]170:369–379. doi: 10.7326/M18-2229
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Published: Ann Intern Med. 2019;170(6):369-379.
Published at www.annals.org on 26 February 2019
Nephrology, Renal Replacement Therapy.
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