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临床试验/NCT05448261
NCT05448261尚未招募不适用

FoStering psychosOcial weLlbeing of Family Caregivers of Stroke surVivors Using Emotion-centered, Problem-solving Approach (SoLVE): A Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2022年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
178
试验地点
1
主要终点
Depressive levels of caregivers

研究概览

简要总结

Stroke is one of the leading causes of disability globally. Stroke survivors generally require lifelong support from family caregivers. The abrupt onset of stroke and associated physical and cognitive impairments result in a series of complex and demanding interactions between family caregivers and stroke survivors. More than 40% of stroke caregivers develop depressive symptoms over time. The depression of family caregivers negatively impacts their physical health and caregiving role and directly affects the mental health and recovery of stroke survivors. Thus, effective strategies for stressful caregiving situations are urgently needed.

As postulated in the relational/problem solving model of stress, problem-solving coping is a cognitive behavioral process that can enhance caregivers' well-being by changing caregiving situations and/or changing their negative emotional stress responses to stressful situations into positive responses. In view of the influence of negative emotions on the cognitive process of an individual, integrating perspective taking as a cognitive reappraisal strategy into the training of problem-solving coping skills may potentially improve the psychosocial well-being of family caregivers.

This mixed method study aims (1) to examine the effects of a emotion-centered problem-solving intervention on the depressive symptoms, problem-solving coping, emotion regulation, caregiving competence, and health-related quality of life of stroke caregivers and on the physical functioning of stroke survivors; (2) to explore the mediating effect of emotion regulation and problem solving coping on caregivers' depressive symptoms, caregiving competence, and health-related quality of life and on stroke survivors' physical functioning; and (3) to understand how intervention influences depressive symptoms from a family caregiver's perspective. A total of 178 family caregivers will be recruited from various non-government organizations and nurse clinics for stroke patients of the Hospital Authority. Participants will be randomly allocated to the intervention group (IG) and control group (CG). Caregivers in the IG will receive an emotion-centered problem-solving intervention adopting a "shared problem, shared action plan" approach, whereas the caregivers in the CG will receive stroke-related education. Outcomes will be measured at baseline, 12 and 36 weeks after study entry.

This study makes the first attempt to develop an emotion-centered problem-solving intervention and examine its effectiveness in the context of stroke caregiving. The findings will advance our understanding of emotional regulation and problem-solving coping strategies for reducing the depressive symptoms of stroke caregivers, ultimately providing a culturally sensitive medical-social service direction for the delivery of community-based rehabilitation services to stroke families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Group allocation will be sealed in an opaque envelope and will be given to the participants according to their sequence of study entry, and will be concealed from outcome assessors.

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

  • •Hong Kong residents, aged 18 years or above;
  • •can understand and provide informed consent (Abbreviated Mental Test, Hong Kong version score ≥6];
  • •with premorbid depressive symptoms (20-item Center of Epidemiology Studies Depression Scale score ≥841);
  • •Chinese family caregivers of stroke survivors who had been diagnosed of ischemic or hemorrhagic stroke within the past 6 months and had residual physical impairment (score of Modified Barthel Index <91);
  • •family members who assume the primary responsibility for caring the stroke patient and who are identified by the stroke patients as their primary caregiver;
  • •with no history of self-reported/doctor diagnosed psychiatric illness

排除标准

  • •Patient-caregiver dyads who are non-Chinese

研究组 & 干预措施

Emotion-centered problem-solving intervention (EPi)

Experimental

The EPi comprises four weekly 60 minutes individual face-to-face session (45 minutes of emotion-centered problem-solving intervention and 15 minutes of stroke education), followed by two bi-weekly telephone follow-ups (30 minutes) and one face-to-face round up session (60 minutes). The content of the stroke education will be based on a developed booklet for local family caregivers (please refer to control group).

干预措施: Emotion-centered problem-solving intervention (EPi) (Behavioral)

Stroke education

Sham Comparator

The CG will receive basic education on stroke caregiving, as research indicates that basic education is not effective in improving problem-solving coping abilities and depressive symptoms. Four weekly individual stroke education (60 minutes/session) will be conducted by a trained research nurse. It will be based on a developed information booklet for local stroke caregivers. The participants will received three biweekly phone calls for general greetings. Questions relating to stroke caregiving raised by the caregivers will be answered according to the educative content. Any extra information provided will be documented.

干预措施: stroke education (Other)

结局指标

主要结局

Depressive levels of caregivers

时间窗: Change of depressive levels from baseline to 3 months and to 9 months

Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale

次要结局

  • Emotion regulation strategies of caregivers(Change of emotion regulation strategies from baseline to 3 months and to 9 months)
  • Caregiving competence of caregivers(Change of caregiving competence from baseline to 3 months and to 9 months)
  • Health-related quality of life of caregivers(Change of health-related quality of life from baseline to 3 months and to 9 months)
  • Problem-solving coping abilities of caregivers(Change of problem-solving coping abilities from baseline to 3 months and to 9 months)
  • Physical functioning of stroke survivors(Change of physical functioning from baseline to 3 months and to 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho Yu CHENG

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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