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Randomized Controlled Trial
. 2016 Mar:47:1-11.
doi: 10.1016/j.cct.2015.11.020. Epub 2015 Nov 24.

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

S Susan Hedayati  1 , Divya M Daniel  2 , Scott Cohen  3 , Bryan Comstock  4 , Daniel Cukor  5 , Yaminette Diaz-Linhart  6 , Laura M Dember  7 , Amelia Dubovsky  8 , Tom Greene  9 , Nancy Grote  10 , Patrick Heagerty  4 , Wayne Katon  8 , Paul L Kimmel  11 , Nancy Kutner  12 , Lori Linke  2 , Davin Quinn  13 , Tessa Rue  4 , Madhukar H Trivedi  14 , Mark Unruh  15 , Steven Weisbord  16 , Bessie A Young  2 , Rajnish Mehrotra  2
Affiliations
Randomized Controlled Trial

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

S Susan Hedayati et al. Contemp Clin Trials. 2016 Mar.

Abstract

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.

Keywords: Cognitive behavioral therapy (CBT); Depression; End Stage Renal Disease (ESRD); Engagement interview; Hemodialysis; Sertraline.

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Figure 1
Figure 1
Schematic of A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients with Depression (or ASCEND) design
See this image and copyright information in PMC

References

    1. U.S. Renal Data System. USRDS 2012 Annual Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
    1. Weisbord SD, et al. Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol. 2005;16(8):2487–94. - PubMed
    1. Fukuhara S, et al. Health-related quality of life among dialysis patients on three continents: the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2003;64(5):1903–10. - PubMed
    1. Mapes DL, et al. Health-related quality of life as a predictor of mortality and hospitalization: the Dialysis Outcomes and Practice Patterns Study (DOPPS) Kidney Int. 2003;64(1):339–49. - PubMed
    1. Chiu YW, et al. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol. 2009;4(6):1089–96. - PMC - PubMed

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