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Cognitive-behavioral (CBT) in ESRD Patients With Depression

S

Seoul National University Boramae Hospital

Status

Completed

Conditions

Quality of Life
Depression
Kidney Failure, Chronic

Treatments

Behavioral: Cognitive-behavioral group therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02011139
CBT-ESRD

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

20+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Group A
Active Comparator group
Description:
12 sessions of Cognitive-behavioral group therapy in the first 12 weeks
Treatment:
Behavioral: Cognitive-behavioral group therapy
Group B
Active Comparator group
Description:
12 sessions of Cognitive-behavioral group therapy in the second 12 weeks
Treatment:
Behavioral: Cognitive-behavioral group therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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