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NCT00618475 · ClinicalTrials.gov registry record · NA

Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis

A NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
NA
Development phase
65
Enrollment target

NCT00618475: Completed NA study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00618475 is a NA study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00618475, a NA study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
NA
Development phase
65 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL Cognitive behavioral therapy

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2008-08
Est. Completion 2012-08
Phase NA

What the finished NCT00618475 record still lists

NCT00618475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Cognitive behavioral therapy is the first listed.

NCT00618475 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00618475 about?

NCT00618475 is a clinical study titled "Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis". 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 stand...

What is the current status of trial NCT00618475?

This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2008-08. Estimated completion is 2012-08.

What interventions are being tested in trial NCT00618475?

The interventions under investigation include: Cognitive behavioral therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT00618475?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00618475's enrollment target sits among peer trials

65 1144th of 2000 higher than 854 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00618475, the US trial registry maintained by the National Library of Medicine. NCT00618475 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.