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
研究组 & 干预措施
Affective touch group
Survivors in the intervention group will receive a total of 36 sessions of a 15-minute affective touch intervention performed by their family caregivers in their homes. Sessions will be scheduled for every alternate weekday (three times a week) for 12 weeks. A trained research nurse (RN) will conduct three 30-minute caregiver training sessions to support the caregivers in delivering the affective touch.
To put caregivers in a more relaxed mood for delivering the intervention, the RN will work with them to identify a time that they feel less burdensome, and teach them to perform deep breathing for relaxation before the affective touching begins. Also, the survivor-caregiver dyad will be asked to sit in a comfortable position and switch off television or radio during the intervention.
干预措施: Affective touch (Behavioral)
Fine motor group
To address the additional attention given by caregivers during affective touch, the control group will be asked to sit beside the survivors when they go through the fine motor exercises which are commonly used for rehabilitation. Caregivers will be instructed to provide only necessary help in preparing the equipment, and to avoid touching or talking to the survivors during the 15-minute exercise session. Two such sessions will be arranged for survivors to master the skills needed, and for caregivers to practise the required level of interaction during the exercise training. Participants will be instructed to do the exercise three times a week (every alternate weekday) over 12 weeks.
干预措施: Fine motor exercise (Other)
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