Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 192
- 主要终点
- Changes on psychological well-being
研究概览
简要总结
The objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.
详细描述
This project is a two-arm randomized controlled trial evaluating the effects of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia. One hundred and ninety-two informal caregivers of people with dementia will be recruited. Participants in the intervention group will receive eight weekly e-bibliotherapy sessions. The control group will get access to the same e-bibliotherapy app but accept only general daily living knowledge. Psychological well-being, caregiving appraisal, mental health, biomarker of stress, and health-related quality of life will be measured to test the effects of e-bibliotherapy immediately post-intervention, three months post-intervention, and six months post-intervention. Focus group interviews will be conducted immediately post-intervention to explore caregivers' experiences participating in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •primary caregivers aged 18 or above;
- •provide unpaid regular care to a person with mild to moderately severe dementia (measured by Global Deterioration Scale, GDS=4~6);
- •have cared for the care recipient for at least six months;
- •assist with at least one of the care recipient's daily activities;
- •use a smartphone or tablet;
- •can read Chinese.
排除标准
- •caregivers with unstable physical or mental conditions;
- •have cognitive impairment;
- •are undergoing acute treatment or have not yet stabilized on their chronic medication;
- •are involved in another interventional study
结局指标
主要结局
Changes on psychological well-being
时间窗: Pre-intervention, immediately post-intervention, three and six-month post-intervention
Psychological well-being will be measured by the Chinese version of Ryff's Psychological Well-being Scale. It is a 6-point Likert scale with 1=strongly disagree to 6=totally agree. It includes 18 items. A higher score indicates better psychological well-being.
次要结局
- Changes on biomarker of stress(Pre-intervention, immediately post-intervention, three and six-month post-intervention)
- Changes on health-related quality of life(Pre-intervention, immediately post-intervention, three and six-month post-intervention)
- Changes on caregiving appraisal(Pre-intervention, immediately post-intervention, three and six-month post-intervention)
- Changes on mental health(Pre-intervention, immediately post-intervention, three and six-month post-intervention)