Effectiveness of Cognitive-behavioral Group Therapy for Enhancing Mental Health and Quality of Life in Maintenance Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory-II (BDI-II) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group A
12 sessions of Cognitive-behavioral group therapy in the first 12 weeks
干预措施: Cognitive-behavioral group therapy (Behavioral)
Group B
12 sessions of Cognitive-behavioral group therapy in the second 12 weeks
干预措施: Cognitive-behavioral group therapy (Behavioral)
结局指标
主要结局
Beck Depression Inventory-II (BDI-II) score
时间窗: 3 months
次要结局
- Secondary assessment tools for depression,anxiety, and quality of life(3 months)
研究者
Chun Soo Lim
Professor
Seoul National University Boramae Hospital