TY - JOUR
T1 - Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)
AU - Hedayati, S. Susan
AU - Daniel, Divya M.
AU - Cohen, Scott
AU - Comstock, Bryan
AU - Cukor, Daniel
AU - Diaz-Linhart, Yaminette
AU - Dember, Laura M.
AU - Dubovsky, Amelia
AU - Greene, Tom
AU - Grote, Nancy
AU - Heagerty, Patrick
AU - Katon, Wayne
AU - Kimmel, Paul L.
AU - Kutner, Nancy
AU - Linke, Lori
AU - Quinn, Davin
AU - Rue, Tessa
AU - Trivedi, Madhukar H.
AU - Unruh, Mark
AU - Weisbord, Steven
AU - Young, Bessie A.
AU - Mehrotra, Rajnish
N1 - Funding Information:
There are no financial disclosures other than listed: Mark Unruh receives research support from Dialysis Clinic, Inc.
Funding Information:
This work was supported by a grant from the Patient-Centered Outcomes Research Institute (PCORI) ( CER-1310-07253 ) and Dialysis Clinics, Inc . Support was also provided by the University of Texas Southwestern Medical Center O'Brien Kidney Research Core Center ( NIDDK , P30DK079328 ) and UT-STAR, NIH /NCATS Grant Number UL1RR024982 . Dr. Young is also supported in part by funding from the Veterans Affairs Puget Sound Health Care System. All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, NIH/NIDDK, or the Veterans Affairs.
Funding Information:
The authors would like to acknowledge the contributions of the following members of the research team: Seattle site, Kristen O''Loughlin, research assistant; Molly Kleklamp, therapist; Dallas site, Francisco Sanchez and Kyle West, research coordinators; Aisha Madden, therapist; Albuquerque site, Talaya Martinez, research coordinator; Alicia Stevens, therapist. We would also like to acknowledge the members of the Data and Safety Monitoring Board (Alan Kliger, Chair, Michael Hollifield, J. R. Landis, Michael Rocco, and Susan Watnick) and clinicians who are members of the Stakeholder Council (Lewis Cohen, Gregory Braden, and Fred Finkelstein). We are grateful to Lori Hartwell and the other members of the Patient Council for their input regarding the study design and implementation. We thank the seven dialysis providers supporting this study and facilitating recruitment from among patients undergoing care – DaVita, Inc., Dialysis Clinic, Inc., Fresenius Medical Care, Renal Ventures, Northwest Kidney Centers, Olympic Peninsula Kidney Centers, and Puget Sound Kidney Centers. Finally, we would like to thank the American Association of Kidney Patients, American Association of Nephrology Nurses, National Kidney Foundation Council of Nephrology Social Workers, Dialysis Patient Citizens, and National Renal Administrators'' Association.
Publisher Copyright:
© 2015 .
PY - 2016/3/1
Y1 - 2016/3/1
N2 - Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes.
AB - Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes.
KW - Cognitive behavioral therapy (CBT)
KW - Depression
KW - End Stage Renal Disease (ESRD)
KW - Engagement interview
KW - Hemodialysis
KW - Sertraline
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UR - http://www.scopus.com/inward/citedby.url?scp=84959339587&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2015.11.020
DO - 10.1016/j.cct.2015.11.020
M3 - Article
C2 - 26621218
AN - SCOPUS:84959339587
SN - 1551-7144
VL - 47
SP - 1
EP - 11
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -