Cognitive-behavioral (CBT) in ESRD Patients With Depression
Effectiveness of Cognitive-behavioral Group Therapy for Enhancing Mental Health and Quality of Life in Maintenance Hemodialysis Patients
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 20, 2015
November 1, 2015
11 months
December 3, 2013
November 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Beck Depression Inventory-II (BDI-II) score
3 months
Secondary Outcomes (9)
Secondary assessment tools for depression,anxiety, and quality of life
3 months
Secondary assessment tools for depression,anxiety, and quality of life
3 months
Secondary assessment tools for depression,anxiety, and quality of life
3 months
Secondary assessment tools for depression,anxiety, and quality of life
3 months
Secondary assessment tools for depression,anxiety, and quality of life
3 months
- +4 more secondary outcomes
Study Arms (2)
Group A
ACTIVE COMPARATOR12 sessions of Cognitive-behavioral group therapy in the first 12 weeks
Group B
ACTIVE COMPARATOR12 sessions of Cognitive-behavioral group therapy in the second 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Boramae Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chun Soo Lim, M.D. PhD
Seoul National University Boramae Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 13, 2013
Study Start
October 1, 2013
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
November 20, 2015
Record last verified: 2015-11