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Contemp Clin Trials. 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).

Author information

1
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.
2
Kidney Research Institute, University of Washington, United States.
3
Division of Nephrology, George Washington University, United States.
4
School of Public Health, University of Washington, United States.
5
Department of Psychiatry, SUNY Downstate Medical Center, United States.
6
Boston Medical Center, Boston University School of Medicine, United States.
7
Division of Nephrology, University of Pennsylvania, United States.
8
Department of Psychiatry, University of Washington, United States.
9
University of Utah, United States.
10
School of Social Work, University of Washington, United States.
11
National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, United States.
12
Emory University, United States.
13
Department of Psychiatry, University of New Mexico, United States.
14
Department of Psychiatry, University of Texas Southwestern Medical Center, United States.
15
Division of Nephrology, University of New Mexico, United States.
16
Division of Nephrology, VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, United States.

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

PMID:
26621218
PMCID:
PMC4818161
[Available on 2017-03-01]
DOI:
10.1016/j.cct.2015.11.020
[Indexed for MEDLINE]
Free PMC Article

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