Clinical trial NCT02011139: Cognitive-behavioral (CBT) in ESRD Patients With Depression
Official title: Effectiveness of Cognitive-behavioral Group Therapy for Enhancing Mental Health and Quality of Life in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Depression
Quality of Life
Lead sponsor: Seoul National University Boramae Hospital
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Beck Depression Inventory-II (BDI-II) score
timeFrame: 3 months
Secondary outcomes:
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
measure: Secondary assessment tools for depression,anxiety, and quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Boramae Hospital
name: Chun Soo Lim, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References: