NCT05952245

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Stroke
• Insomnia
• Depressive Symptoms
• Caregiver Burnout
• Psychological Distress
• Mobile Phone Use

Interventions

Type	Name	Description
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).
BEHAVIORAL	Education-based EMI	Stroke and brief sleep hygiene education with chat-based support on the topics.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2023-07-19
• Last updated: 2024-05-30

Locations

5 sites across 1 country: Hong Kong