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Completed

NCT Number: NCT02011139

Cognitive-behavioral (CBT) in ESRD Patients With Depression

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.

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Key information

Conditions

Kidney Failure, Chronic Behavior Behavioral Symptoms Chronic Disease Depression Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Boramae Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral group therapy

Behavioral

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

    Time frame: 3 months

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

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

    Time frame: 3 months

    Beck Anxiety Inventory (BAI)

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

    Time frame: 3 months

    The Perceived Stress Scale

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

    Time frame: 3 months

    KD-QOL: quality of life related with kidney disease

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

    Time frame: 3 months

    WHOQOL_BREF: overall quality of life

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

    Time frame: 3 months

    Temperament and Character Inventory (TCI)

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

    Time frame: 3 months

    Diagnosis of major depressive disorder by DSM-IV

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

    Time frame: 3 months

    Biomarker related with depression: serotonin level and etc.

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

    Time frame: 3 months

    Additional anti-depressant use after trial

Sponsors and collaborators

Lead sponsor

Seoul National University Boramae Hospital

Other

Registry information

Official study title

Effectiveness of Cognitive-behavioral Group Therapy for Enhancing Mental Health and Quality of Life in Maintenance Hemodialysis Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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