Expired Study
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Brooklyn, New York 11203


Purpose:

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.


Criteria:

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 -


Study is Available At:


Original ID:

K23DK076980


NCT ID:

NCT00618475


Secondary ID:

K23DK076980


Study Acronym:


Brief Title:

Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

65


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel Cukor, PhD.
Principal Investigator
State University of New York - Downstate Medical Center

Study Dates

Start Date:August 2008
Completion Date:August 2012
Completion Type:Actual
Primary Completion Date:August 2011
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 14, 2017
First Received Date:February 15, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Clinical biomarkers
Time Frame:baseline, completion, 3 month follow-up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of Life
Time Frame:baseline, completion, 3 month follow-up
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Beck Depression Inventory
Time Frame:baseline, completion, 3 month follow-up
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive behavioral therapy
Description:10 sessions 1 hour per week
Arm Name:Treatment

Study Arms

Study Arm Type:Other
Arm Name:Wait-list control
Description:Individual cognitive behavioral therapy (CBT) after 3 month wait-list period
Study Arm Type:Experimental
Arm Name:Treatment
Description:Individual cognitive behavioral therapy (CBT)

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Cukor D, Ver Halen N, Asher DR, Coplan JD, Weedon J, Wyka KE, Saggi SJ, Kimmel PL. Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis. J Am Soc Nephrol. 2014 Jan;25(1):196-206. doi: 10.1681/ASN.2012111134. Epub 2013 Oct 10.
PMID:24115478

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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