Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00618475
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2008-02-15
Brief Title:
Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients overall coping and functioning To better understand the patients 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 subjects mental health history and treatment as well as current medications will be gathered Data from routine dialysis laboratories hemoglobin creatinine albumin KtV 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
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 patients overall coping and functioning To better understand the patients 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 subjects mental health history and treatment as well as current medications will be gathered Data from routine dialysis laboratories hemoglobin creatinine albumin KtV 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DK076980 | NIH | None | httpsreporternihgovquickSearchK23DK076980 |