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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 12 sessions of Cognitive-behavioral group therapy in the first 12 weeks |
|
| Group B | Active Comparator | 12 sessions of Cognitive-behavioral group therapy in the second 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral group therapy | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) score | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Soo Lim, M.D. PhD | Seoul National University Boramae Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Boramae Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |