title: Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).
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.
authors.affiliation: Renal Section, VA North Texas Health Care System, United States; Division of Nephrology, University of Texas Southwestern Medical Center, United States. Electronic address: susan.hedayati@va.gov.
authors.forename: S Susan
authors.initials: SS
authors.lastname: Hedayati
authors.affiliation: Kidney Research Institute, University of Washington, United States.
authors.forename: Divya M
authors.initials: DM
authors.lastname: Daniel
authors.affiliation: Division of Nephrology, George Washington University, United States.
authors.forename: Scott
authors.initials: S
authors.lastname: Cohen
authors.affiliation: School of Public Health, University of Washington, United States.
authors.forename: Bryan
authors.initials: B
authors.lastname: Comstock
authors.affiliation: Department of Psychiatry, SUNY Downstate Medical Center, United States.
authors.forename: Daniel
authors.initials: D
authors.lastname: Cukor
authors.affiliation: Boston Medical Center, Boston University School of Medicine, United States.
authors.forename: Yaminette
authors.initials: Y
authors.lastname: Diaz-Linhart
authors.affiliation: Division of Nephrology, University of Pennsylvania, United States.
authors.forename: Laura M
authors.initials: LM
authors.lastname: Dember
authors.affiliation: Department of Psychiatry, University of Washington, United States.
authors.forename: Amelia
authors.initials: A
authors.lastname: Dubovsky
authors.affiliation: University of Utah, United States.
authors.forename: Tom
authors.initials: T
authors.lastname: Greene
authors.affiliation: School of Social Work, University of Washington, United States.
authors.forename: Nancy
authors.initials: N
authors.lastname: Grote
authors.affiliation: School of Public Health, University of Washington, United States.
authors.forename: Patrick
authors.initials: P
authors.lastname: Heagerty
authors.affiliation: Department of Psychiatry, University of Washington, United States.
authors.forename: Wayne
authors.initials: W
authors.lastname: Katon
authors.affiliation: National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, United States.
authors.forename: Paul L
authors.initials: PL
authors.lastname: Kimmel
authors.affiliation: Emory University, United States.
authors.forename: Nancy
authors.initials: N
authors.lastname: Kutner
authors.affiliation: Kidney Research Institute, University of Washington, United States.
authors.forename: Lori
authors.initials: L
authors.lastname: Linke
authors.affiliation: Department of Psychiatry, University of New Mexico, United States.
authors.forename: Davin
authors.initials: D
authors.lastname: Quinn
authors.affiliation: School of Public Health, University of Washington, United States.
authors.forename: Tessa
authors.initials: T
authors.lastname: Rue
authors.affiliation: Department of Psychiatry, University of Texas Southwestern Medical Center, United States.
authors.forename: Madhukar H
authors.initials: MH
authors.lastname: Trivedi
authors.affiliation: Division of Nephrology, University of New Mexico, United States.
authors.forename: Mark
authors.initials: M
authors.lastname: Unruh
authors.affiliation: Division of Nephrology, VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, United States.
authors.forename: Steven
authors.initials: S
authors.lastname: Weisbord
authors.affiliation: Kidney Research Institute, University of Washington, United States.
authors.forename: Bessie A
authors.initials: BA
authors.lastname: Young
authors.affiliation: Kidney Research Institute, University of Washington, United States.
authors.forename: Rajnish
authors.initials: R
authors.lastname: Mehrotra
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D015897:Comorbidity; D003863:Depression / Q000453:epidemiology / Q000523:psychology / Q000628:therapy; D003865:Major Depressive Disorder / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D019263:Dysthymic Disorder / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D006435:Renal Dialysis; D020280:Sertraline / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D020280:Sertraline
keywords: Cognitive behavioral therapy (CBT); Depression; End Stage Renal Disease (ESRD); Engagement interview; Hemodialysis; Sertraline