Cognitive-behavioral (CBT) in ESRD Patients With Depression

Effectiveness of Cognitive-behavioral Group Therapy for Enhancing Mental Health and Quality of Life in Maintenance Hemodialysis Patients

Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on the quality of life, functional ability, and mortality, with a prevalence rate as high as 20-25%. However, it is hard to use anti-depressant due to the safety issue, and there has been little data so far particularly in terms of randomized clinical trials. Here, we investigate the effect of cognitive-behavioral group therapy for enhancing mental health and quality of life in patients with ESRD.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Kidney Failure, Chronic
• Intervention / Treatment: Behavioral: Cognitive-behavioral group therapy

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Boramae Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with end-stage renal disease : on hemodialysis more than 3 months
• Patients with BDI-II score >= 15 points
• Adult with age >= 20 years old
• Patients who were able to understand and willing to sign the written informed consent

Exclusion Criteria:

• Patients on hemodialysis due to acute kidney injury
• Patients who are on admission
• Patients who are undergoing chemotherapy or radiation therapy due to progressive malignant disease
• Patients who are planning kidney transplantation within few months
• Patients with cognitive dysfunction, mental retardation, and drug addict
• Patients who are unavailable for adequate communication with researchers
• Patients who changed anti-depressive agent or dose within 2 months before/after the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 12 sessions of Cognitive-behavioral group therapy in the first 12 weeks	Behavioral: Cognitive-behavioral group therapy
Active Comparator: Group B; 12 sessions of Cognitive-behavioral group therapy in the second 12 weeks	Behavioral: Cognitive-behavioral group therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory-II (BDI-II) score	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary assessment tools for depression,anxiety, and quality of life	Hamilton Depression Rating Scale (HAMD-17): assessment for depressive mood	3 months
Secondary assessment tools for depression,anxiety, and quality of life	Beck Anxiety Inventory (BAI)	3 months
Secondary assessment tools for depression,anxiety, and quality of life	The Perceived Stress Scale	3 months
Secondary assessment tools for depression,anxiety, and quality of life	KD-QOL: quality of life related with kidney disease	3 months
Secondary assessment tools for depression,anxiety, and quality of life	WHOQOL_BREF: overall quality of life	3 months
Secondary assessment tools for depression,anxiety, and quality of life	Temperament and Character Inventory (TCI)	3 months
Secondary assessment tools for depression,anxiety, and quality of life	Diagnosis of major depressive disorder by DSM-IV	3 months
Secondary assessment tools for depression,anxiety, and quality of life	Biomarker related with depression: serotonin level and etc.	3 months
Secondary assessment tools for depression,anxiety, and quality of life	Additional anti-depressant use after trial	3 months

Collaborators and Investigators

• Sponsor: Seoul National University Boramae Hospital
• Investigators: Principal Investigator: Chun Soo Lim, M.D. PhD, Seoul National University Boramae Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Depression; Depressive Disorder; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: CBT-ESRD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No