Patients whose kidneys fail generally require dialysis treatments to sustain life. Most patients undergo hemodialysis, a treatment that takes three to four hours and is performed in a dialysis facility three times a week. They need to make significant changes to their diet and are asked to take about 17 pills daily. The ability of patients to make such major adjustments in their lives is hampered by depression that affects almost one-quarter of such individuals. Yet many doctors do not offer depression treatment, and when offered, many dialysis patients are reluctant to accept it. This is, in part, because there are no studies that have adequately tested whether treatment for depression is effective in dialysis patients, or if there is any difference between the responses to the two most commonly available forms of treatment, psychotherapy and antidepressant drug therapy.
To fill this important gap in our knowledge, the study team proposes to undertake (1) a randomized controlled clinical trial of 400 patients to test whether an engagement interview will result in a higher proportion of dialysis patients accepting treatment for depression and (2) a randomized controlled clinical trial of 180 patients to determine whether there is any difference in the likelihood of improvement of depressive symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients in these studies will be enrolled from 50 dialysis facilities in three metropolitan areas—Seattle, Dallas, and Albuquerque.
The research proposal has been developed with the support of patients, caregivers, and stakeholders to ensure that the findings from the study are relevant to them and can be readily implemented in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and the dose of the study drug will be changed in partnership with the study participants.
In addition to depressive symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will be determined. A single research assistant will ascertain the potential benefits of treatment by computer-assisted telephone interviewing with the patient at home. Upon completion of treatment in the clinical trial, each patient will be invited to undergo a semistructured interview to describe their experience with the intervention.
The two forms of depression treatment being tested in this clinical trial are very different from each other, and patients differ with regard to the treatment option preferable or available to them. Successful completion of the clinical trial will provide patients, caregivers, and other stakeholders with the information that they would need when faced with a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to select evidence-based treatments to improve outcomes that are relevant to them.
|Article Highlight: Patients undergoing long-term treatment for kidney failure often also experience depression. In this PCORI-funded study, more patients reported modest improvements in their depressive symptoms with the drug sertraline than patients who received cognitive behavioral therapy, the study’s researchers report in the Annals of Internal Medicine. However, patients who opted for the daily medication experienced more adverse events, such as nausea and dizziness.|