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Treatment options for depression in patients undergoing hemodialysis
Investigator (PI): Mehrotra, Rajnish
Performing Organization (PO): (Current): University of Washington, School of Medicine, Department of Medicine, Division of Nephrology, Kidney Research Institute / (206) 616-8574
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: PCORI/CER-1310-07253
Funding: Total Award Amount: $2,115,373
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Patients whose kidneys fail generally require dialysis treatments to sustain life. Most patients undergo hemodialysis, a treatment that takes 3-4 hours and is performed in a dialysis facility three times a week. They need to make significant changes in 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 treatment for depression, and when offered, many dialysis patients are reluctant to accept any treatment. This is, in part, because there are no studies that have adequately tested whether treatment of depression is effective in dialysis patients and if there is any difference between the response to the two most commonly available forms of treatment--psychotherapy and anti-depressant drug therapy. To fill this important gap in our knowledge, we propose 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 among individuals receiving care in 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 with 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 semi-structured interview to describe the experience with the intervention. The two forms of treatment for depression being tested in this clinical trial are very different from each other and patients differ with regards to the treatment option preferable and/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.
MeSH Terms:
  • Antidepressive Agents /therapeutic use
  • Depression /*complications
  • /*therapy
  • Evidence-Based Medicine
  • Humans
  • New Mexico
  • Outcome Assessment, Health Care
  • Psychotherapy /methods
  • Randomized Controlled Trials as Topic
  • Renal Dialysis /*methods
  • Renal Insufficiency /*psychology
  • /*therapy
  • Software
  • Telemedicine /methods
  • Texas
  • Washington
Country: United States
State: Washington
Zip Code: 98104
UI: 20152183
CTgovId: NCT02358343
Project Status: Completed
Record History: ('2019: Project extended to 2019 ',) ('2017: Project extended to 2018',)