Family Caregivers Affective Touching for Improving Depressive Symptoms of Community Dwelling Stroke Survivors Through Security Priming
试验速览
- 阶段
- 不适用
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Change of number of depressive symptoms of stroke survivors at 9 months
研究概览
简要总结
This mixed-method study includes a randomised controlled trial and an exploratory qualitative study, and aims to examine the effects of caregiver-delivered affective touch on depressive symptoms, state of attachment security, self-esteem, and perceived family harmony among stroke survivors, and to explore the mediating effect of attachment security and how an intervention may affect depressive symptoms from stroke survivor's perspective. A total of 184 survivor-caregiver dyads will be recruited from various non-governmental organisations. The dyads will be randomly allocated to intervention (IG) and control (CG) groups, stratified by the survivor's attachment style. IG caregivers will be taught to deliver a 15-minute affective touch intervention to stroke survivors. To address the attention effect, CG caregivers will be asked to sit with the survivors during a 15-minute fine motor coordination exercise. Both activities, affective touching and fine motor exercise, will be performed for 12 weeks (3 times/week), and the outcomes mentioned earlier will be measured at baseline, 12 and 36 weeks after study entry.
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
- Single (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
- 是
入选标准
- •Stroke survivor-caregiver dyads
- •Hong Kong residents, aged 18 years or above,
- •able to understand and give informed consent [Abbreviated Mental Test (Hong Kong version) score ≥6].
- •Stroke survivors
- •within the first three months of being diagnosed with first-onset acute ischemic/haemorrhagic stroke,
- •able to comprehend verbal instructions,
- •with premorbid depressive symptoms [20-item Centre of Epidemiology Studies Depression Scale score ≥8].
- •Family caregivers
- •family members who assume the primary responsibility for caring for a stroke survivor and who are identified by the survivors as their primary caregivers,
- •live with the survivors and provide care ≥4 hours/day,
- •have no history of self-reported or medical diagnosis of psychiatric illness,
- •are able to learn and willing to provide the intervention.
排除标准
- •Stroke survivor-caregiver dyads who are not Chinese
结局指标
主要结局
Change of number of depressive symptoms of stroke survivors at 9 months
时间窗: Change of baseline number of depressive symptoms at 9 months
Number of depressive symptoms of stroke survivors will be measured by the Chinese version of the 20-item Centre of Epidemiology Studies Depression Scale, which rates participant's mood on a four-point Likert scale (0 = rarely or none of the time, 3 = almost or all of the time), higher score indicating more severe symptoms.
Change of number of depressive symptoms of stroke survivors at 3 months
时间窗: Change of baseline number of depressive symptoms at 3 months
Number of depressive symptoms of stroke survivors will be measured by the Chinese version of the 20-item Centre of Epidemiology Studies Depression Scale, which rates participant's mood on a four-point Likert scale (0 = rarely or none of the time, 3 = almost or all of the time), higher score indicating more severe symptoms.
次要结局
- Change of state of attachment security of stroke survivors at 3 and 9 months(Baseline, 3 and 9 months)
- Change of perceived family harmony of stroke survivors at 3 and 9 months(Baseline, 3 and 9 months)
- Change of state self-esteem of stroke survivors at 3 and 9 months(Baseline, 3 and 9 months)
研究者
Ho Yu CHENG
Assistant professor
Chinese University of Hong Kong