Cognitive-behavioral (CBT) in ESRD Patients With Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Failure, Chronic, Depression, Quality of Life

Intervention / Treatment
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* Behavioral: Cognitive-behavioral group therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |