Among end-stage renal disease (ESRD) patients on hemodialysis, drug treatment for depression was moderately more effective than cognitive behavioral therapy (CBT), the two-phased ASCEND clinical trial found.
Measured by the Quick Inventory of Depressive Symptoms (QIDS-C), severity of depression symptoms improved more with 12 weeks of sertraline (Zoloft) treatment than with CBT for ESRD patients on hemodialysis (effect estimate vs CBT for QIDS-C: -1.84, 95% CI -3.54 to -0.13, P=0.035), reported Rajnish Mehrotra, MD, of the University of Washington in Seattle, and colleagues in the Annals of Internal Medicine.
Although improvements in depression symptoms were greater with sertraline treatment — titrated up to a 200-mg dose — patients who were randomized to receive 10 60-minute sessions of CBT in the dialysis center also experienced a benefit after 12 weeks of intervention:
- CBT: QIDS-C score 12.2 at baseline vs 8.1 at 12 weeks
- Sertraline: 10.9 vs 5.9
However, an engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression, the authors noted.
Also, despite the greater treatment benefit seen with sertraline, more adverse events (AEs) were reported with treatment compared with CBT. Overall, 18 serious AEs, such as hospitalization or death, were reported among those on sertraline versus 13 events with CBT. For gastrointestinal, cardiac, and nervous system-related issues, 17 AEs were reported with CBT compared with 56 with sertraline.
In an accompanying editorial, Jennifer Flythe, MD, MPH, of the University of North Carolina in Chapel Hill, praised the trial for it’s “many strengths,” but noted that the “small differential efficacy across treatment groups is of questionable clinical significance, suggesting that clinicians may offer both therapeutic options without concern for compromising outcomes.”
She also recommended the importance of shared decision-making with the patient, underscoring that “Although pill burden or adverse effect concerns may sway some patients toward chairside CBT, others may prefer pharmacologic therapy because of privacy concerns or other matters.”
“Cognitive behavioral therapy and drug treatment, the 2 most common approaches to major depressive disorder, have similar efficacy in the general population,” Mehrotra’s group wrote. “Clinical practice guidelines recommend either method as first-line therapy for mild or moderate depression, with the choice guided by patient preference and availability.”
In 2016, the Centers for Medicare & Medicaid Services mandated that all U.S. dialysis clinics screen patients for depression, and subsequently outline a treatment strategy for patients who receive a diagnosis of depression.
The open-label ASCEND (A Trial of Sertraline vs Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression) trial included 184 patients from 41 centers on maintenance hemodialysis for at least 3 months and a diagnosis of depression, defined as a score of 15+ on the Beck Depression Inventory-II scale.
Prior to the treatment-initiation phase, the first phase of the trial involved face-to-face evaluations of these patients during hemodialysis, which were conducted by trained therapists. These engagement interviews, which were compared with control visits, were designed to help the patient accept the depression diagnosis, and to then increase willingness to accept sertraline therapy or CBT, which was the second phase of the trial.
To assess the effect of engagement interviews on treatment initiation, the therapists showed the patients a 20-minute video on depression and treatment options while utilizing a motivational interviewing technique. The researchers reported that 66% of patients chose to initiate depression treatment after these engagement interviews compared with 64% of control patients. They explained that this has been the case “perhaps because such an interview lacks efficacy in this patient population.”
“Another possibility is that awareness of the study’s primary goal of comparing depression treatments may have led to preselection of participants who were more willing to accept treatment,” the authors stated, highlighting a study limitation.
Other limitations included the fact that no randomized comparison was made with no treatment, and the persistence of treatment effect was not assessed.
The authors noted that “the reasons for the greater efﬁcacy of sertraline in this study are not clear.” One possible reason could be that sertraline preferentially targets the somatic symptoms of depression (insomnia, hypersomnia, fatigue) that also are common in patients who have depression and are on hemodialysis.
“Another possibility is that the high burden of disease and treatment in patients receiving maintenance hemodialysis makes their engagement in CBT more challenging,” they wrote.
“The information from this clinical trial should facilitate individualized patient and provider decisions on options for treating depression in patients receiving maintenance hemodialysis,” the authors concluded.
The trial was funded by the Patient-Centered Outcomes Research Institute at the Dialysis Clinic in Nashville, and the Kidney Research Institute at the University of Washington, as well as supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Mehrotra disclosed no relevant relationships with industry. Co-authors disclosed multiple relevant relationships with industry.
Flythe disclosed support from the NIDDK.