NCT05490069已完成不适用
The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
研究概览
简要总结
The proposed pilot trial aims to evaluate the feasibility of iCBT based EMI, which is a real-time, real-world, personalised and cost-effective approach, for stroke survivors' psychological well-being.
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
- •Diagnosis of stroke (ICD-10 codes: I60-I69)
- •Able to read and communicate in Chinese (Cantonese or Putonghua)
- •Able to use text messaging function on mobile phones
- •MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)
- •Discharged home from hospital within preceding 6 months
- •PHQ-9 (depressive symptom) score range from 5 to 19 (cf. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)
排除标准
- •Currently receiving active stroke care in acute or post-acute inpatient settings
- •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 intervention (e.g., CBT)
研究组 & 干预措施
Intervention group
Experimental
Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.
干预措施: iCBT-based EMI (Other)
Control group
No Intervention
Receive general mental health information through instant message.
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)
- Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])(24-week)
- Loneliness (UCLA Loneliness Scale [ULS-8])(24-week)
研究者
研究点 (7)
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