Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers

Study Overview
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Brief Summary
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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.

Detailed Description
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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( e.g., WhatsApp) as personalised and real-time psychological support led by nurses for 12 weeks. The control group will only receive stroke education messages and chat-based psychological support without the CBT-I content. 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, and quality of life. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI.

Official Title
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The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) in Stroke Family Caregivers: a Mixed Method Study

Conditions
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Depressive Symptoms, Stroke, Insomnia, Caregiver Burnout, Psychological Distress, Mobile Phone Use

Intervention / Treatment
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* Behavioral: iCBTI-based EMI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ≤ 20 scores (i.e., clinically significant insomnia) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Receiving CBT-I based EMI messages. | Behavioral: iCBTI-based EMI<br>* 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).<br>|
| No Intervention: Control Group<br>Receiving stroke education messages. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 
| Insomnia Severity Index (ISI) | A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 24 weeks | 
| Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L]) | A generic tool for Patient-Reported Outcomes measurement that can assess patients' quality of life, irrespective of the disease. | 24 weeks |