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Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis

This study has been completed.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: February 15, 2008
Last updated: March 25, 2016
Last verified: March 2016

Depression is second in frequency only to hypertension as a comorbid condition for End Stage Renal Disease (ESRD) patients. The presence of depression has been linked to lower quality of life, more medical comorbidities and shorter lifespan. This project represents the first known attempt at a standardized intervention for depression in ethnically diverse ESRD patients. The study will be conducted at the Parkside Center for Dialysis. Patients will be randomly selected for screening until 80 subjects meet entry criteria and agree to be randomized. Once subjects are screened and enrolled in the study they are randomly assigned to either a treatment or wait-list control condition. After 3 months, the intervention will be completed and both groups will be reassessed. After an additional 3 months, both groups will have received the intervention and pre and post measures for both groups will be available as well as 3 month follow-up for the 1st intervention group.

The following measures will be collected: to obtain a full DSM-IV diagnosis the SCID I and SCID II will be utilized. The BDI will provide a self-report measure of depression. The Hospital Anxiety and Depression Scale (HADS), a measure designed specifically for medically ill patients, will also be administered. Additionally, the Young Schema Questionnaire, a measure which seeks to identify maladaptive (both depressive and anxious) cognitive styles, will be administered. A quality of life measure designed specifically for dialysis patients (KDQOL-SF) will also be given as a means of measuring patient's overall coping and functioning. To better understand the patient's perceptions of their health and illness the Illness Effects Questionnaire will be administered. A demographic information sheet will be completed by the subject in which personal, ethnic, and illness information is collected. Detailed information about the subject's mental health history and treatment as well as current medications will be gathered. Data from routine dialysis laboratories (hemoglobin, creatinine, albumin, Kt/V) will be extracted from the chart.

The intervention will take place in individual format while the subjects are being dialyzed. The intervention will be 10 sixty minute -long weekly sessions spread over not more than 3 months. It will include both cognitive and behavioral skills focused on alleviating depressive affect and identifying maladaptive patterns of thought and behavior. This study would lay the groundwork for future clinical research by helping to develop a culturally competent clinical intervention and demonstrate the feasibility and effectiveness of adapting psychosocial intervention for a medically complex culturally diverse population.

Condition Intervention
End Stage Renal Disease Depression Behavioral: Cognitive behavioral therapy

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: baseline, completion, 3 month follow-up ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: baseline, completion, 3 month follow-up ]
  • Clinical biomarkers [ Time Frame: baseline, completion, 3 month follow-up ]

Enrollment: 65
Study Start Date: August 2008
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Behavioral: Cognitive behavioral therapy

10 sessions

1 hour per week

wait-list control
Behavioral: Cognitive behavioral therapy

10 sessions

1 hour per week


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ESRD patients treated with hemodialysis

Inclusion Criteria:

- hemodialysis patient Depression diagnosis

Exclusion Criteria:

(1) presence of current organic mental disorder (2) schizophrenia (3) bipolar disorder (4) depression with psychotic features (5) current substance abuse or dependence (6) active suicidal intent or plan (7) active homicidal ideation, intent, or plan -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00618475

United States, New York
Parkside Hemodialysis
Brooklyn, New York, United States, 11203
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Daniel Cukor, PhD. State University of New York - Downstate Medical Center
  More Information

Responsible Party: Daniel Cukor PhD, SUNY Downstate Medical Center Identifier: NCT00618475     History of Changes
Other Study ID Numbers: K23DK076980 ( U.S. NIH Grant/Contract )
Study First Received: February 15, 2008
Last Updated: March 25, 2016

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
End Stage Renal Disease
Kidney Disease
Mental Health

Additional relevant MeSH terms:
Depressive Disorder
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency processed this record on July 28, 2017