Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 5
- 主要终点
- Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
研究概览
简要总结
Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. A recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively.
An evidence profile report by the World Health Organization(WHO) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. Therefore, early psychological intervention (EPI) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving.
The main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. Internet-delivered cognitive-behavioural therapy (iCBT) is delivered as an ecological momentary intervention (EMI) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.
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 first-ever stroke patient who has <15 modified Barthel Index(mBI) scores (moderate disability);
- •Caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days;
- •Aged ≥18;
- •Able to read and communicate in Chinese (Cantonese or Putonghua);
- •Able to use mobile phone instant messaging function; and
- •PHQ-9 (depressive symptom) score ranging from 5 to 19 (note. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)
排除标准
- •Caregiver of stroke patient who is admitted to intensive care unit;
- •Professional medical personnel and/or professional carer;
- •Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants;
- •PHQ-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and
- •Currently participating in any type of psychological intervention.
结局指标
主要结局
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
时间窗: 24-week
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
次要结局
- Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])(24-week)
- Stress level (Perceived Stress Scale [PSS-4])(24-week)
- Loneliness level (UCLA Loneliness Scale [ULS-8])(24-week)
- Acceptance and Action Questionnaire-II (AAQ-II)(24-week)