Cognitive-behavioral (CBT) in ESRD Patients With Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011139
• Other study ID #: CBT-ESRD
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: November 17, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Seoul National University Boramae Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Kidney Failure, Chronic
• Quality of Life
• Renal Insufficiency

Intervention

Behavioral:
• Cognitive-behavioral group therapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory-II (BDI-II) score		3 months	No
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	Hamilton Depression Rating Scale (HAMD-17): assessment for depressive mood	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	Beck Anxiety Inventory (BAI)	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	The Perceived Stress Scale	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	KD-QOL: quality of life related with kidney disease	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	WHOQOL_BREF: overall quality of life	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	Temperament and Character Inventory (TCI)	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	Diagnosis of major depressive disorder by DSM-IV	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	Biomarker related with depression: serotonin level and etc.	3 months	Yes
Secondary	Secondary assessment tools for depression,anxiety, and quality of life	Additional anti-depressant use after trial	3 months	Yes