What was the research about?
In patients with kidney disease, the kidneys don’t work well to remove waste from the blood. Some people with kidney disease have kidney failure and have lost most of their kidney function. These patients often receive dialysis, a treatment with a machine that cleans the blood. Patients usually go to a dialysis center for this treatment, about three times each week. Depression is common in people with kidney failure who receive dialysis.
In this study, the research team compared how likely patients were to start treatment for depression after talking with a therapist during a dialysis visit versus getting dialysis as usual. For patients who did start treatment, the team compared two treatments for depression in patients getting dialysis:
- Cognitive behavioral therapy, or CBT, a type of talk therapy. In CBT, patients learn to change patterns in their thinking to improve how they feel.
- Sertraline, a medicine used to treat depression.
What were the results?
Patients who didn’t talk with a therapist were just as likely to start treatment for depression as those who talked with a therapist.
After 12 weeks of treatment, both sertraline and CBT reduced symptoms of depression. The two treatments worked about the same.
Compared with patients who had CBT, patients treated with sertraline scored better on surveys that asked about their quality of life, including how much energy they had and how well they slept.
Attendance at dialysis sessions was similar for patients getting either treatment for depression.
Who was in the study?
The study included 184 patients with kidney failure getting dialysis at centers in three large cities in New Mexico, Texas, and Washington State. Of these patients, 120 wanted to receive treatment for depression. Forty-three percent of these patients were white, 28 percent were black, and 21 percent were another race; 28 percent were Hispanic. The average age was 51, and 57 percent were men.
What did the research team do?
The research team assigned patients by chance to one of two groups. In one group, patients met with a therapist during one of their dialysis sessions. The therapist asked them about their symptoms of depression and concerns about treatment. In the other group, patients received dialysis but did not meet with a therapist.
The research team then assigned patients who wanted to start treatment for depression by chance to one of two groups. In one group, patients took sertraline for 12 weeks. Patients could fill their prescriptions at the dialysis center. In the second group, the team scheduled patients for 10 one-on-one CBT sessions with a trained therapist. The sessions took place over 12 weeks during dialysis.
Patients completed surveys about symptoms of depression and quality of life before treatment started and again 6 and 12 weeks later.
Patients with kidney disease, doctors, nurses, social workers, and managers of dialysis centers helped design the study.
What were the limits of the study?
The study didn’t look at how well the treatments worked compared with no treatment. As a result, the research team can’t say for sure that changes were because of either treatment. The research team didn’t look at the effects of treatment beyond 12 weeks.
Future research could study whether combining sertraline and CBT is more effective than either treatment alone.
How can people use the results?
Patients on dialysis and their doctors can use the results when considering treatments for depression.
(1) To determine the effect of an engagement interview on acceptance of treatment for depression; (2) To compare the efficacy of sertraline versus cognitive behavioral therapy (CBT) for depression symptoms among patients with end-stage renal disease (ESRD) receiving hemodialysis
|Design||Randomized controlled trial|
|Population||184 patients age 21 or older with ESRD and major depressive disorder or dysthymia receiving outpatient hemodialysis|
Secondary: nine patient-reported outcome measures, including depression symptoms (Beck Depression Inventory II), sleep, and satisfaction with life; treatment adherence
|Timeframe||12-week follow-up for treatment primary outcome|
This randomized controlled trial compared (1) two strategies to encourage patients to start treatment for depression, and (2) two treatments for depression in patients with ESRD and major depressive disorder or dysthymia receiving outpatient hemodialysis.
Researchers randomly assigned participants to either an engagement interview during dialysis to improve acceptance of the diagnosis of depression and interest in treatment or to usual care. Then researchers randomly assigned participants who wanted to start treatment for depression to receive either sertraline or CBT. In the sertraline group, patients started at a dose of 25 mg/day and were individually titrated to a maximum of 200 mg/day over six weeks. Patients were able to fill sertraline prescriptions at the dialysis center. In the CBT group, researchers scheduled patients for 10 individual CBT sessions over 12 weeks while they received outpatient hemodialysis. Trained therapists with master’s degrees in social work counseled patients on modifying negative thoughts, practicing healthy living skills, and building support networks.
At baseline and again 6 and 12 weeks later, researchers administered the Quick Inventory of Depressive Symptomatology, Clinician-Rated (QIDS-C) to assess depression symptoms and severity and evaluated other patient-reported outcomes. To assess adherence to hemodialysis, researchers tracked skipped or shortened hemodialysis sessions and changes in weight and serum phosphorus levels over the treatment period.
The study included 184 patients receiving hemodialysis for at least three months at community-based dialysis centers in large cities in New Mexico, Texas, and Washington State; 120 were randomized to treatment for depression. Of these patients, 43% were white, 28% were black, and 21% were another race; 28% were Hispanic. The average age was 51, and 57% were male.
People with ESRD, patient advocacy organizations, physicians, nurses, social workers, and managers of dialysis centers helped design the study.
Engagement interview. The proportion of people who accepted treatment for depression within 28 days did not differ between patients receiving an engagement interview or usual care.
Treatment. After 12 weeks, both sertraline and CBT reduced symptoms of depression. Compared with patients treated with CBT, patients treated with sertraline had greater improvement in symptoms of depression on the QIDS-C (p=0.04) and Beck Depression Inventory II (p<0.05) and four other patient-reported outcome measures, including energy level and sleep quality (p<0.05). Although statistically significant, it is unclear whether the differences in depression symptoms were clinically meaningful.
Adherence to hemodialysis did not differ between the two treatments for depression.
Without a no-treatment comparison, this study cannot establish with certainty that the changes from before to after treatment were a result of sertraline or CBT. Researchers did not examine the persistence of effect after the 12-week treatment period.
Conclusions and Relevance
Both sertraline and CBT improved depression symptoms in patients with ESRD receiving outpatient hemodialysis. Patients treated with sertraline had greater improvement in depression symptoms compared with patients treated with CBT, but the difference between groups may not be clinically meaningful.
Future Research Needs
Future research could investigate the efficacy of combining CBT and pharmacotherapy and the effects of other antidepressants.
Final Research Report
View this project's final research report.
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.
Results of This Project
Related Journal Citations
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Some reviewers felt that the lack of a placebo arm was a serious limitation. The researchers edited the background section to note that six previous trials have compared cognitive behavioral therapy (CBT) and drug therapy in treating depression in patients undergoing dialysis, so the researchers felt the more important knowledge gap in this population was in the comparative effectiveness of CBT versus antidepressant drug therapy. The researchers acknowledged as a limitation that their study design did not allow them to demonstrate that either treatment was superior to placebo or to no treatment.
- Reviewers commented that 12 weeks is a very short duration of follow-up. The researchers agreed and acknowledged this as a limitation of the study. But they noted that patients who do not respond to antidepressant medication within 12 weeks are unlikely to do so, and they added that previous trials of CBT and antidepressant drug therapy in dialysis patients have also followed patients for 12 weeks and sometimes less.
- Reviewers noted that a very low proportion of patients initially included in the study used the tools presented and wondered whether that reflected the acceptability of the tools. The researchers clarified that while they approached more than 2500 dialysis patients, the large majority did not have depressive symptoms. Therefore, they were appropriately excluded from the clinical trial. Many patients with depressive symptoms were also appropriately excluded because they were already receiving treatment for depression or did not have symptoms of sufficient severity to qualify. Ultimately, the researchers said, the proportion of patients included in this clinical trial was similar to that of other similar, successful trials.
Conflict of Interest Disclosures
Study Registration Information
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