Cognitive-behavioral (CBT) in ESRD Patients With Depression

Not Applicable

Completed

• Conditions: Depression; Quality of Life; Kidney Failure, Chronic
• Interventions: Behavioral: Cognitive-behavioral group therapy

• Registration Number: NCT02011139
• Lead Sponsor: Seoul National University Boramae Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Cognitive-behavioral group therapy	12 sessions of Cognitive-behavioral group therapy in the second 12 weeks
Group A	Cognitive-behavioral group therapy	12 sessions of Cognitive-behavioral group therapy in the first 12 weeks

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory-II (BDI-II) score	3 months

Secondary Outcome Measures

Name	Time	Method
Secondary assessment tools for depression,anxiety, and quality of life	3 months	Additional anti-depressant use after trial

Trial Locations

Locations (1)

Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of