Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis

NCT00618475 | Completed

• 1 other identifier: K23DK076980
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Depression

Keywords

Depression; End Stage Renal Disease; Kidney Disease; Mental Health

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory

  baseline, completion, 3 month follow-up

Secondary Outcomes (2)

• Quality of Life

  baseline, completion, 3 month follow-up

• Clinical biomarkers

  baseline, completion, 3 month follow-up

Study Arms (2)

Treatment

EXPERIMENTAL

Individual cognitive behavioral therapy (CBT)

Behavioral: Cognitive behavioral therapy

Wait-list control

OTHER

Individual cognitive behavioral therapy (CBT) after 3 month wait-list period

Behavioral: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

10 sessions 1 hour per week

Treatment; Wait-list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- hemodialysis patient Depression diagnosis

You may not qualify if:

• (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 -

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Parkside Hemodialysis

Brooklyn, New York, 11203, United States

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Depression; Kidney Diseases; Psychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Daniel Cukor, PhD.

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 20, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

US (1)