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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02011139
Other study ID # CBT-ESRD
Secondary ID
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


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
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