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.

Decreasing hospitalizations in patients on hemodialysis: Time for a paradigm shift

“…Validated measures show a strong association between treatment adherence, engagement with outpatient resources, and mortality outcomes . Symptoms of anxiety and depression are extremely common and linked with dialysis and dietary nonadherence behaviors . Kimmel et al showed that perception of burden of illness and poor social support correlate with treatment of nonadherence, frequent hospitalization, and mortality .…”

“…Cukor et al showed that behavioral therapy designed to improve self‐efficacy improved dialysis adherence in the short term . Other interventions, such as cognitive behavioral therapy as a means to improve perception of illness burden and social support, have been shown to lower morbidity and hospitalization rates in patients with ESRD …”

“…[87][88][89][90][91][92][93][94][95][96] Symptoms of anxiety and depression are extremely common and linked with dialysis and dietary nonadherence behaviors. 90,91,[97][98][99][100][101][102][103][104] Kimmel et al showed that perception of burden of illness and poor social support correlate with treatment of nonadherence, frequent hospitalization, and mortality. 105,106 Low self-efficacy (the ability of an individual to set goals and the belief that those goals can be achieved) is common in dialysis patients and up to a third of patients on hemodialysis have low self-efficacy.…”

“…93 Other interventions, such as cognitive behavioral therapy as a means to improve perception of illness burden and social support, have been shown to lower morbidity and hospitalization rates in patients with ESRD. [104][105][106]121 Social support plays a role in self-efficacy. Support from family and friends is associated with better fluid adherence, and higher rates of social support are associated with improved dialysis treatment adherence.…”

Prognostic Utility of a Self-Reported Depression Questionnaire versus Clinician-Based Assessment on Renal Outcomes

“…We chose to evaluate the 16-item Quick Inventory of Depressive Symptomatology-Self Report scale (QIDS-SR 16 ) in this regard (see supplement) because: 1) it is in the public domain and short and easy for practitioners to use [20]; 2) it evaluates the same 9 criterion symptom domains that define a major depressive episode for a diagnosis of MDD in both the fourth and fifth editions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) [21, 22]; 3) we previously validated the QIDS-SR 16 against a DSM-based interview for diagnosis of MDD among non-dialysis CKD patients [23]; 4) and, finally, a clinician-based version of the QIDS is currently being used as the primary outcome measure in 2 ongoing large randomized controlled trials of depression treatment in non-dialysis CKD [24] and ESRD patients [25]. …”