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CompletedNCT02011139Updated Nov 20, 2015

Cognitive-behavioral (CBT) in ESRD Patients With Depression

An interventional study of Cognitive-behavioral group therapy in Kidney Failure, Chronic, Depression and Quality of Life, sponsored by Seoul National University Boramae Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-11-20.

Sponsored by Seoul National University Boramae Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Failure, Chronic
  • Depression
  • Quality of Life
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 15 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Seoul National University Boramae Hospital is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    Group A

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

    Behavioral: Cognitive-behavioral group therapy

  • Active comparator
    Group B

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

    Behavioral: Cognitive-behavioral group therapy

Interventions

  • BehavioralCognitive-behavioral group therapy
06

What researchers measure

Primary outcomes

  1. Beck Depression Inventory-II (BDI-II) score

    Time frame: 3 months

Secondary outcomes

  1. Secondary assessment tools for depression,anxiety, and quality of life

    Hamilton Depression Rating Scale (HAMD-17): assessment for depressive mood

    Time frame: 3 months

  2. Secondary assessment tools for depression,anxiety, and quality of life

    Beck Anxiety Inventory (BAI)

    Time frame: 3 months

  3. Secondary assessment tools for depression,anxiety, and quality of life

    The Perceived Stress Scale

    Time frame: 3 months

  4. Secondary assessment tools for depression,anxiety, and quality of life

    KD-QOL: quality of life related with kidney disease

    Time frame: 3 months

  5. Secondary assessment tools for depression,anxiety, and quality of life

    WHOQOL_BREF: overall quality of life

    Time frame: 3 months

  6. Secondary assessment tools for depression,anxiety, and quality of life

    Temperament and Character Inventory (TCI)

    Time frame: 3 months

  7. Secondary assessment tools for depression,anxiety, and quality of life

    Diagnosis of major depressive disorder by DSM-IV

    Time frame: 3 months

  8. Secondary assessment tools for depression,anxiety, and quality of life

    Biomarker related with depression: serotonin level and etc.

    Time frame: 3 months

  9. Secondary assessment tools for depression,anxiety, and quality of life

    Additional anti-depressant use after trial

    Time frame: 3 months

07

Study locations

1 site
  • Seoul National University Boramae Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02011139
Lead sponsor
Seoul National University Boramae Hospital
Responsible party
Chun Soo Lim (Professor, Seoul National University Boramae Hospital) — Principal investigator
First posted
Dec 13, 2013
Start date
Oct 2013
Primary completion
Sep 2014
Completion
Dec 2014
Last update
Nov 20, 2015

Study contacts

Chun Soo Lim, M.D. PhD
principal investigator · Seoul National University Boramae Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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