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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
138
Including brief iCBT-I for sleep support, stroke care education, and nurse-led real-time chat-based support messages, which were delivered according to participants' preferences (e.g., time and frequency).
Stroke and brief sleep hygiene education with chat-based support on the topics.
Hong Kong PHAB Association
Hong Kong, Hong Kong
RECRUITINGHong Kong Stroke Association
Hong Kong, Hong Kong
RECRUITINGNT West Community Centre
Hong Kong, Hong Kong
RECRUITINGSleep Condition Indicator (SCI)
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.
Time frame: 24 weeks
Insomnia Severity Index (ISI)
A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
Time frame: 24 weeks
Sleep quality (Pittsburgh Sleep Quality Index [PSQI])
A 19-item scale ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
Time frame: 24 weeks
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
Time frame: 24 weeks
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom
Time frame: 24 weeks
Caregiver's burden (Zarit Burden Interview [ZBI-4])
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden
Time frame: 24 weeks
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity, with scores ranging from -0.864 to 1, where higher scores indicate better quality of life. Additionally, it includes a visual analogue scale (VAS), ranging from 0 (the worst health imaginable) to 100 (the best health imaginable).
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Queen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGThe Hong Kong Society for Rehabilitation
Hong Kong, Hong Kong
RECRUITINGTime frame: 24 weeks
Positive experiences from caregiving (Positive Aspect of Caregiving [PAC])
An 11-item scale with scores ranging from 0 to 44. A higher score indicates a more positive caregiving experience.
Time frame: 24 weeks
Caregiving self-efficacy (Caregiving Self-Efficacy Scale [CSES-8])
An 8-item scale with scores ranging from 1 to 10, with higher scores indicating higher self-efficacy.
Time frame: 24 weeks
Sleep parameters (Consensus Sleep Diary Core Version)
The Consensus Sleep Diary Core Version will be used to collect sleep parameters (e.g., sleep efficiency and total sleep time).
Time frame: 24 weeks
Dysfunctional Beliefs and attitudes about Sleep (Dysfunctional Beliefs and attitudes about Sleep [DBAS])
A 16-item scale with scores ranging from 0 to 160, with higher scores indicating greater dysfunctional beliefs about sleep.
Time frame: 24 weeks
Sleep hygiene statue (Sleep Hygiene Index [SHI])
A 13-item scale with ratings from 0 to 52, where higher scores indicate poorer sleep hygiene status.
Time frame: 24 weeks
Sleep-related behavior (Chinese short-form of the sleep-related behavior questionnaire [SRBQ-SF])
A 23-item scale with scores ranging from 0 to 92. A higher score indicates more sleep-related safety behaviors.
Time frame: 24 weeks
State of sleep effort (Glasgow Sleep Effort Scale [GSES])
A 7-item scale with scores ranging from 0 to 14, where higher scores indicate greater effort to sleep over the past week.
Time frame: 24 weeks
Sleep-related quality of life (Glasgow Sleep Impact Index [GSII])
The primary measureable outcomes for the GSII reflect VAS scores (0-100; with lower scores reflecting negative impact) for each of the three specified ranks, capturing impairment in the past two weeks. GSII reflect VAS scores (0-100; with lower scores reflecting negative impact) for each of the three
Time frame: 24 weeks
Feedback on iCBT-I intervention
Feedback on the sleep support programme will be collected, focusing on various aspects such as perceived usefulness and willingness to recommend the program. Each aspect will be evaluated using a 5-point Likert scale, where higher scores indicate more positive evaluations.
Time frame: 24 weeks
Adverse events
Feedback on adverse events related to the iCBT-I intervention, such as fatigue, will be collected.
Time frame: 24 weeks