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

Not Applicable

Recruiting

• Conditions: Depressive Symptoms; Mobile Phone Use; Caregiver Burnout; Insomnia; Stroke; Psychological Distress
• Interventions: Behavioral: iCBTI-based EMI; Behavioral: Education-based EMI

• Registration Number: NCT05952245
• Lead Sponsor: The University of Hong Kong

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.

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-19
• Study Start: 2023-12-01
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	iCBTI-based EMI	Receiving CBT-I based EMI messages.
Control Group	Education-based EMI	Receiving education-based EMI messages.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Positive experiences from caregiving (Positive Aspect of Caregiving [PAC])	24 weeks	An 11-item scale with scores ranging from 0 to 44. A higher score indicates a more positive caregiving experience.
State of sleep effort (Glasgow Sleep Effort Scale [GSES])	24 weeks	A 7-item scale with scores ranging from 0 to 14, where higher scores indicate greater effort to sleep over the past week.
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
Caregiving self-efficacy (Caregiving Self-Efficacy Scale [CSES-8])	24 weeks	An 8-item scale with scores ranging from 1 to 10, with higher scores indicating higher self-efficacy.
Sleep parameters (Consensus Sleep Diary Core Version)	24 weeks	The Consensus Sleep Diary Core Version will be used to collect sleep parameters (e.g., sleep efficiency and total sleep time).
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
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])	24 weeks	The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity, with scores ranging from -0.864 to 1, where higher scores indicate better quality of life.; Additionally, it includes a visual analogue scale (VAS), ranging from 0 (the worst health imaginable) to 100 (the best health imaginable).
Sleep hygiene statue (Sleep Hygiene Index [SHI])	24 weeks	A 13-item scale with ratings from 0 to 52, where higher scores indicate poorer sleep hygiene status.
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
Dysfunctional Beliefs and attitudes about Sleep (Dysfunctional Beliefs and attitudes about Sleep [DBAS])	24 weeks	A 16-item scale with scores ranging from 0 to 160, with higher scores indicating greater dysfunctional beliefs about sleep.
Sleep-related behavior (Chinese short-form of the sleep-related behavior questionnaire [SRBQ-SF])	24 weeks	A 23-item scale with scores ranging from 0 to 92. A higher score indicates more sleep-related safety behaviors.
Sleep-related quality of life (Glasgow Sleep Impact Index [GSII])	24 weeks	The primary measureable outcomes for the GSII reflect VAS scores (0-100; with lower scores reflecting negative impact) for each of the three specified ranks, capturing impairment in the past two weeks.; GSII reflect VAS scores (0-100; with lower scores reflecting negative impact) for each of the three
Feedback on iCBT-I intervention	24 weeks	Feedback on the sleep support programme will be collected, focusing on various aspects such as perceived usefulness and willingness to recommend the program. Each aspect will be evaluated using a 5-point Likert scale, where higher scores indicate more positive evaluations.
Adverse events	24 weeks	Feedback on adverse events related to the iCBT-I intervention, such as fatigue, will be collected.

Trial Locations

Locations (5)

Hong Kong Stroke Association; 🇭🇰 Hong Kong, Hong Kong

The Hong Kong Society for Rehabilitation; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

NT West Community Centre; 🇭🇰 Hong Kong, Hong Kong

Hong Kong PHAB Association; 🇭🇰 Hong Kong, Hong Kong