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

• Authors: S. Susan Hedayati, University of Texas Southwestern Medical Center; Divya M. Daniel, University of Washington; Scott Cohen, George Washington University; Bryan Comstock Comstock, University of Washington; Daniel Cukor, SUNY Downstate Medical Center; Yaminette Diaz-Linhart, Boston University; Laura M. Dember, University of Pennsylvania; Amelia Dubovsky, University of Washington; Tom Greene, University of Utah; Nancy Grote, University of Washington; Patrick Heagerty, University of Washington; Wayne Katon, University of Washington; Paul L. Kimmel, National Institute of Diabetes; Nancy Kutner, Emory University; Lori Linke, University of Washington; Davin Quinn, University of New Mexico; Tessa Rue, University of Washington; Madhukar H. Trivedi, University of Texas Southwestern Medical Center; Mark Unruh, University of New Mexico; Steven Weisbord, VA Pittsburgh Healthcare System; Bessie A. Young, University of Washington; Rajnish Mehrotra, University of Washington
• Journal Title: Contemporary Clinical Trials
• Volume: Volume 47
• Publisher: Elsevier | 2016-03-01, Pages 1-11
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.cct.2015.11.020
• Subjects: Psychology, Behavioral; Health Sciences, Mental Health; Psychology, Clinical
• Keywords: Science & Technology; Life Sciences & Biomedicine; Medicine, Research & Experimental; Pharmacology & Pharmacy; Research & Experimental Medicine; End Stage Renal Disease (ESRD); Hemodialysis; Depression; Engagement interview; Cognitive behavioral therapy (CBT); Sertraline; QUALITY-OF-LIFE; CHRONIC KIDNEY-DISEASE; CHRONIC-HEMODIALYSIS PATIENTS; INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW; PERITONEAL-DIALYSIS PATIENTS; MAJOR DEPRESSION; PRACTICE PATTERNS; ANTIDEPRESSANT TREATMENT; PSYCHOSOCIAL FACTORS; NUTRITIONAL-STATUS

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.