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Cognitive-behavioral (CBT) in ESRD Patients With Depression

NCT ID: NCT02011139

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Failure, Chronic Depression Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral group therapy

Intervention Type BEHAVIORAL

Group B

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

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral group therapy

Intervention Type BEHAVIORAL

Interventions

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Cognitive-behavioral group therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Boramae Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chun Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun Soo Lim, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Boramae Hospital

Locations

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Seoul National University Boramae Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CBT-ESRD

Identifier Type: -

Identifier Source: org_study_id