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

The University of Hong Kong (HKU)

Status: Enrolling

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

Treatments: Behavioral: iCBTI-based EMI; Behavioral: Education-based EMI

Study type: Interventional

Funder types: Other

Identifiers

NCT05952245

CBTI2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ≤ 21 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Receiving CBT-I based EMI messages.

Treatment:

Behavioral: iCBTI-based EMI

Control Group

Active Comparator group

Description:

Receiving education-based EMI messages.

Treatment:

Behavioral: Education-based EMI