An interventional study of iCBTI-based EMI and Education-based EMI in Stroke, Insomnia and Depressive Symptoms, sponsored by The University of Hong Kong. Recruiting at 5 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Other
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 138 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receiving CBT-I based EMI messages.
Behavioral: iCBTI-based EMI
Receiving education-based EMI messages.
Behavioral: Education-based EMI
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.
Sleep 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).
Time 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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Hong Kong