The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks
研究概览
简要总结
The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress.
详细描述
75% of stroke caregivers report severe caregiver burdens, with 60% of stroke caregivers reporting at least one depressive symptom in Hong Kong. However, caregivers can experience difficulties in accessing and fully utilising existing services due to the varying types of care needs and its intensities amongst stroke survivors.
Ecological momentary intervention (EMI) as an innovative and personalised intervention has shown great potential in supporting psychological well-being; yet, there are no studies on using EMI for the caregivers' psychological support. The proposed trial aims to reduce stroke caregivers' psychological distress by delivering EMI through instant messaging applications to provide personalised and real-time support led by healthcare professionals.
Stroke caregivers screened by Patient Health Questionnaire-9 (PHQ-9) with scores ranging from 5 to 19 will be recruited from multiple sites including community centres, rehabilitation centres and outpatient clinics in public hospitals in Hong Kong, and individually randomised into the intervention group (n=20) or control group (n=20). The intervention group will receive the personalised instant messages for 4 weeks. The control group will receive general health information and regular messages reminding them to participate in follow-up surveys. The primary outcome will be the score of PHQ-9 at 4 weeks. Secondary outcomes will include anxiety, perceived stress, and caregiver burden.
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
- Double (Participant, Investigator)
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 family caregiver of stroke survivor
- •Able to read and communicate in Chinese
- •Able to use mobile phone text messaging function
- •PHQ-9 ranged from 5 to 19
排除标准
- •Professional medical personnel and care assistants
- •Has provided care for <1 month prior to recruitment
- •Has diagnosis of psychiatric disease or is currently taking psychotropic drug
- •PHQ-9 ≥ 20 (i.e., severe depressive symptom)
- •Currently participating in any type of psychological support intervention
结局指标
主要结局
Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks
时间窗: 4 weeks
Patient Health Questionnaire (PHQ-9) Scale: PHQ-9 is a scale for screening depression in primary care. It consists of 9 items with 4 likert scale. Score range is from 0 to 27 (higher score = higher severity of depressive symptom).
次要结局
- Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks(4 weeks)
- Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks(4 weeks)
- Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks(4 weeks)
研究者
Dr. Jung-Jae Lee
Research Assistant Professor
The University of Hong Kong