NCT02418806已完成不适用
Group Therapy for Caregivers of Alzheimer's Disease Patients in Spanish Elderly Persons Centres
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation11 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 11
- 主要终点
- Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.
研究概览
简要总结
An experimental study designed to test the effectiveness of a psychological intervention based on group therapy for the caregivers of Alzheimer's disease patients. The intervention consists of 16 sessions of a cognitive-behavioral psychological group therapy. This study aims to demonstrate that Alzheimer's patients' caregivers can decrease the feelings of burden after been involved in a group therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main caregiver of an Alzheimer Disease Patient.
- •Alzheimer Disease Patient with mild/severe cognitive impairment.
- •High compliance to therapy sessions.
- •Sign informed consent.
排除标准
- •Low commitment to develop all study phases.
- •Caregiver activity remunerated.
- •Caregiver with psychiatric disorders that can affect the development of the sessions.
- •Caregivers who have received psychological care during last year.
结局指标
主要结局
Efficacy of group therapy in caregiver burden measured by Zarit Burden Interview.
时间窗: 16 months
次要结局
- Change in resilience from baseline compared to the control and active arms measured by Connor-Davidson Resilience Scale.(4 months - 16 months)
- Change in caregiver burden from baseline compared to the control and active arms measured by Zarit Burden Interview.(4 months and 16 months)
- Change in anxiety and depression from baseline compared to the control and active arms measured by Goldberg Scale.(4 months and 16 months)
- Descriptive analysis of the caregivers' characteristics (sociodemographics, relation wih the AD patient).(Baseline (0 months))
- Descriptive analysis of the caregiver's cognition using DEM-DETECT Module 1.(4 months)
- Preliminary cost-effectiveness analysis related resources needed to caregivers and Alzheimer patients.(4 months - 16 months)
- Change in quality of life from baseline compared to the control and active arms measured by Casp-19 and SF-36 questionnaires.(4 months - 16 months)
- Change in functional social support from baseline compared to the control and active arms using Duke-UNC questionnaire.(4 months - 16 months)
研究者
研究点 (11)
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