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Cognitive-behavioral (CBT) in ESRD Patients With Depression

Primary Purpose

Kidney Failure, Chronic, Depression, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cognitive-behavioral group therapy
Sponsored by
Seoul National University Boramae Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Failure, Chronic

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Boramae Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

12 sessions of Cognitive-behavioral group therapy in the first 12 weeks

12 sessions of Cognitive-behavioral group therapy in the second 12 weeks

Outcomes

Primary Outcome Measures

Beck Depression Inventory-II (BDI-II) score

Secondary Outcome Measures

Secondary assessment tools for depression,anxiety, and quality of life
Hamilton Depression Rating Scale (HAMD-17): assessment for depressive mood
Secondary assessment tools for depression,anxiety, and quality of life
Beck Anxiety Inventory (BAI)
Secondary assessment tools for depression,anxiety, and quality of life
The Perceived Stress Scale
Secondary assessment tools for depression,anxiety, and quality of life
KD-QOL: quality of life related with kidney disease
Secondary assessment tools for depression,anxiety, and quality of life
WHOQOL_BREF: overall quality of life
Secondary assessment tools for depression,anxiety, and quality of life
Temperament and Character Inventory (TCI)
Secondary assessment tools for depression,anxiety, and quality of life
Diagnosis of major depressive disorder by DSM-IV
Secondary assessment tools for depression,anxiety, and quality of life
Biomarker related with depression: serotonin level and etc.
Secondary assessment tools for depression,anxiety, and quality of life
Additional anti-depressant use after trial

Full Information

First Posted
December 3, 2013
Last Updated
November 17, 2015
Sponsor
Seoul National University Boramae Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02011139
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Boramae Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Depression, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
12 sessions of Cognitive-behavioral group therapy in the first 12 weeks
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
12 sessions of Cognitive-behavioral group therapy in the second 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral group therapy
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II (BDI-II) score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
Hamilton Depression Rating Scale (HAMD-17): assessment for depressive mood
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
Beck Anxiety Inventory (BAI)
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
The Perceived Stress Scale
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
KD-QOL: quality of life related with kidney disease
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
WHOQOL_BREF: overall quality of life
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
Temperament and Character Inventory (TCI)
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
Diagnosis of major depressive disorder by DSM-IV
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
Biomarker related with depression: serotonin level and etc.
Time Frame
3 months
Title
Secondary assessment tools for depression,anxiety, and quality of life
Description
Additional anti-depressant use after trial
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Soo Lim, M.D. PhD
Organizational Affiliation
Seoul National University Boramae Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Boramae Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Cognitive-behavioral (CBT) in ESRD Patients With Depression

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