Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00618475
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:

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 or disease Intervention/treatment
End Stage Renal Disease Depression Behavioral: Cognitive behavioral therapy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2008
Primary Completion Date : August 2011
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment
Individual cognitive behavioral therapy (CBT)
Behavioral: Cognitive behavioral therapy

10 sessions

1 hour per week

Wait-list control
Individual cognitive behavioral therapy (CBT) after 3 month wait-list period
Behavioral: Cognitive behavioral therapy

10 sessions

1 hour per week

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00618475     History of Changes
Other Study ID Numbers: K23DK076980 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Behavioral Symptoms
Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency