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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-03-31

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.

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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 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

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Stroke Insomnia Depressive Symptoms Caregiver Burnout Psychological Distress Mobile Phone Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention Group

Receiving CBT-I based EMI messages.

Group Type EXPERIMENTAL

iCBTI-based EMI

Intervention Type BEHAVIORAL

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).

Control Group

Receiving education-based EMI messages.

Group Type ACTIVE_COMPARATOR

Education-based EMI

Intervention Type BEHAVIORAL

Stroke and brief sleep hygiene education with chat-based support on the topics.

Interventions

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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).

Intervention Type BEHAVIORAL

Education-based EMI

Stroke and brief sleep hygiene education with chat-based support on the topics.

Intervention Type BEHAVIORAL

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 ≤ 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No