Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.
详细描述
After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.
The clinical trial will include a control group (waiting list).
Patients who meet eligibility requirements will be assigned to control group or intervention group.
Psychological intervention will consist in an 8-session individual face-to-face delivered ACT-based treatment.
The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.
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 (Participant)
盲法说明
Participants did not know that two different treatments were delivered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease on haemodialysis
- •Older than 18 years-old
- •At least 3 months on haemodialysis
- •HADS Global Scale Score ≥14
排除标准
- •Diagnosis of severe or chronic mental disorder, mental retardation and cognitive impairment, or disabling illness.
- •Antidepressant drugs consume
- •Insufficient understanding of Spanish.
- •Patients who are in the Advanced Chronic Kidney Disease Unit
- •Receiving other psychological treatment
结局指标
主要结局
Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)
时间窗: Change from Baseline Emotional Distress at 5 months
HADS assesses anxiety, depression and emotional distress. It is a 14-item four-point Likert-type scale. Scores range between 0 and 42. Higher the score in the overall score indicate higher levels of emotional distress and worse outcome.
次要结局
- Change in Simplified Medication Adherence Questionnaire (SMAQ)(Change from Baseline Adherence at 5 months)
- Change in COOP/WONCA questionnaire(Change from Baseline health related Quality of Life at 5 months)
- Change in mood assessed through Daylio App(Change from Baseline mood at 5 months)
- Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II)(Change from Baseline psychological inflexibility at 5 months)
- Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)(Change from Baseline coping strategies at 5 months)