The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) 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
- 138
- 试验地点
- 5
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The proposed trial aims to assess the effectiveness of Cognitive-behavioural therapy for insomnia (CBT-I) based ecological momentary intervention (EMI) for reducing insomnia symptoms among stroke caregivers.
详细描述
Existing studies reported that 40-95% of family caregivers had clinically significant insomnia symptoms including reduced total sleep duration, prolonged sleep onset latency, frequent night awakenings, and poor sleep efficiency and quality.
Cognitive-behavioural therapy for insomnia (CBT-I) has shown a large effect in reducing insomnia among adults. Innovative and interactive technologies, such as Internet-delivered CBT-I (iCBT-T), have therefore been incorporated into CBT-I, which was identified to have similar effects to that of traditional CBT-I.
In the proposed trial, screened stroke caregivers will be recruited from community centres, rehabilitation centres, and tertiary hospitals in HK. The intervention group will receive CBTI-based EMI through instant messaging applications as personalised and real-time psychological support led by nurses for 3 months. The control group will only receive stroke and brief sleep hygiene education with chat-based support on the topics.The primary outcomes are Sleep Condition Indicator (SCI) and Insomnia Severity Index (ISI) scores. Secondary outcomes will include sleep quality, depressive symptoms, anxiety symptoms, caregiver's burden, quality of life, and et al. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI.
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 (Aged ≥18) of stroke survivor
- •Able to read and communicate in Chinese
- •Engaged caregiving roles for > 4 hours per day;
- •Able to use a smartphone messaging app (e.g., WhatsApp and WeChat)
- •SCI ≤ 21 scores (i.e., clinically significant insomnia)
排除标准
- •Has provided care for <1 month prior to recruitment
- •Has a diagnosis of psychiatric disease or is currently taking psychotropic drugs
- •Currently taking medication to help with sleep
- •Currently participating in any type of psychological intervention
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 24 weeks
A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
Sleep Condition Indicator (SCI)
时间窗: 24 weeks
An eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. Possible total score ranges from 0 to 32, with higher values indicative of better sleep.
次要结局
- Caregiver's burden (Zarit Burden Interview [ZBI-4])(24 weeks)
- Positive experiences from caregiving (Positive Aspect of Caregiving [PAC])(24 weeks)
- State of sleep effort (Glasgow Sleep Effort Scale [GSES])(24 weeks)
- Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])(24 weeks)
- Caregiving self-efficacy (Caregiving Self-Efficacy Scale [CSES-8])(24 weeks)
- Sleep parameters (Consensus Sleep Diary Core Version)(24 weeks)
- Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):(24 weeks)
- Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])(24 weeks)
- Sleep hygiene statue (Sleep Hygiene Index [SHI])(24 weeks)
- Sleep quality (Pittsburgh Sleep Quality Index [PSQI])(24 weeks)
- Dysfunctional Beliefs and attitudes about Sleep (Dysfunctional Beliefs and attitudes about Sleep [DBAS])(24 weeks)
- Sleep-related behavior (Chinese short-form of the sleep-related behavior questionnaire [SRBQ-SF])(24 weeks)
- Sleep-related quality of life (Glasgow Sleep Impact Index [GSII])(24 weeks)
- Feedback on iCBT-I intervention(24 weeks)
- Adverse events(24 weeks)