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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2008-08 |
| Est. Completion | 2012-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00618475
The ClinicalTrials.gov registry entry for NCT00618475 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cognitive behavioral therapy is the first listed.
NCT00618475 reports 0 study locations.
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.
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