Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group Receiving CBT-I based EMI messages. |
Behavioral: iCBTI-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).
|
| No Intervention: Control Group Receiving stroke education messages. |
Outcome Measures
Primary Outcome Measures
- Sleep Condition Indicator (SCI) [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.
- Insomnia Severity Index (ISI) [24 weeks]
A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
Secondary Outcome Measures
- Sleep quality (Pittsburgh Sleep Quality Index [PSQI]) [24 weeks]
A 19-item scale ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
- Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]): [24 weeks]
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
- Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7]) [24 weeks]
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom
- Caregiver's burden (Zarit Burden Interview [ZBI-4]) [24 weeks]
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden
- Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L]) [24 weeks]
A generic tool for Patient-Reported Outcomes measurement that can assess patients' quality of life, irrespective of the disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary family caregiver (Aged ≥18) of stroke survivor
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Able to read and communicate in Chinese
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Engaged caregiving roles for > 4 hours per day;
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Able to use a smartphone messaging app (e.g., WhatsApp and WeChat)
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SCI ≤ 20 scores (i.e., clinically significant insomnia)
Exclusion Criteria:
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Has provided care for <1 month prior to recruitment
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Has a diagnosis of psychiatric disease or is currently taking psychotropic drugs
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Currently taking medication to help with sleep
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Currently participating in any type of psychological intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hong Kong PHAB Association | Hong Kong | Hong Kong | ||
| 2 | Hong Kong Stroke Association | Hong Kong | Hong Kong | ||
| 3 | NT West Community Centre | Hong Kong | Hong Kong | ||
| 4 | Queen Mary Hospital | Hong Kong | Hong Kong | ||
| 5 | The Hong Kong Society for Rehabilitation | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The University of Hong Kong
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBTI2023