Randomized Controlled Trial to Evaluate the Effect of a Cognitive Behavioral Program and Resilient Model in the Treatment of Depression and Anxiety and Impact on the Quality of Life in End-Stage Renal Disease Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).
研究概览
简要总结
This study evaluates the effect of a single cognitive-behavioral intervention (CBI) in a control group against the same CBI plus the strengthening of resiliency skills in an experimental group, on ESRD patients.
详细描述
Cognitive behavioral therapy has long been an alternative in the treatment of symptoms of depression and anxiety in patients with chronic diseases such as renal failure, however the combination of therapeutic approaches that include not only pathological but also another more positive approach (as the resilient model), represents a novel proposal for the treatment of negative psychological symptoms and improvement of the quality of life in these patients.
The inclusion of the resilient model in a cognitive behavioral intervention serves as a possibility of therapeutic target that could enhance the effectiveness of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Evaluation measures
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18, and younger than 61 years old
- •Depression score in the Beck Depression Inventory (BDI) greater than 30 points.
- •Anxiety score in the Beck Anxiety Inventory (BAI) greater than 40 points.
- •Have not been hospitalized over the last 6 months
- •Signing of informed consent
排除标准
- •May not be able to communicate in the Spanish language.
- •Presence of psychiatric comorbidity (suicide ideation or depressive or anxious).
研究组 & 干预措施
CBI and Resilience
8 sessions total, once a week, 2 hours long each, consistent of 6 sessions of Cognitive-behavioral Intervention (CBI) plus 2 sessions to improve resilience strengths.
干预措施: CBI and Resilience (Behavioral)
Cognitive-behavioral Intervention
8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening.
干预措施: Cognitive-behavioral Intervention (Behavioral)
结局指标
主要结局
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).
时间窗: From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.
Outcome measuring will be held at the baseline, after finishing the intervention (8 weeks), and after a following period of 5 weeks. Tool: Kidney Disease Quality of life (KDQOL 36)
次要结局
未报告次要终点
研究者
Cristina Jazmin Gonzalez Flores
Principal Investigator
Hospital Civil de Guadalajara