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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952245
• Other study ID #: CBTI2023
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: June 2023
• Source: The University of Hong Kong
• Contact: Jung Jae LEE
• Phone: +852 3917 6971
• Email: leejay[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Depression
• Depressive Symptoms
• Insomnia
• Mobile Phone Use
• Psychological Distress
• Sleep Initiation and Maintenance Disorders
• Stroke

Intervention

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).
• Education-based EMI
Stroke and brief sleep hygiene education with chat-based support on the topics.

Locations

Country	Name	City	State
Hong Kong	Hong Kong PHAB Association	Hong Kong
Hong Kong	Hong Kong Stroke Association	Hong Kong
Hong Kong	NT West Community Centre	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	The Hong Kong Society for Rehabilitation	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Condition Indicator (SCI)	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.	24 weeks
Primary	Insomnia Severity Index (ISI)	A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms	24 weeks
Secondary	Sleep quality (Pittsburgh Sleep Quality Index [PSQI])	A 19-item scale ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality	24 weeks
Secondary	Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):	A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom	24 weeks
Secondary	Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])	A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptom	24 weeks
Secondary	Caregiver's burden (Zarit Burden Interview [ZBI-4])	A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden	24 weeks
Secondary	Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])	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).	24 weeks
Secondary	Positive experiences from caregiving (Positive Aspect of Caregiving [PAC])	An 11-item scale with scores ranging from 0 to 44. A higher score indicates a more positive caregiving experience.	24 weeks
Secondary	Caregiving self-efficacy (Caregiving Self-Efficacy Scale [CSES-8])	An 8-item scale with scores ranging from 1 to 10, with higher scores indicating higher self-efficacy.	24 weeks
Secondary	Sleep parameters (Consensus Sleep Diary Core Version)	The Consensus Sleep Diary Core Version will be used to collect sleep parameters (e.g., sleep efficiency and total sleep time).	24 weeks
Secondary	Dysfunctional Beliefs and attitudes about Sleep (Dysfunctional Beliefs and attitudes about Sleep [DBAS])	A 16-item scale with scores ranging from 0 to 160, with higher scores indicating greater dysfunctional beliefs about sleep.	24 weeks
Secondary	Sleep hygiene statue (Sleep Hygiene Index [SHI])	A 13-item scale with ratings from 0 to 52, where higher scores indicate poorer sleep hygiene status.	24 weeks
Secondary	Sleep-related behavior (Chinese short-form of the sleep-related behavior questionnaire [SRBQ-SF])	A 23-item scale with scores ranging from 0 to 92. A higher score indicates more sleep-related safety behaviors.	24 weeks
Secondary	State of sleep effort (Glasgow Sleep Effort Scale [GSES])	A 7-item scale with scores ranging from 0 to 14, where higher scores indicate greater effort to sleep over the past week.	24 weeks
Secondary	Sleep-related quality of life (Glasgow Sleep Impact Index [GSII])	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	24 weeks
Secondary	Feedback on iCBT-I intervention	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.	24 weeks
Secondary	Adverse events	Feedback on adverse events related to the iCBT-I intervention, such as fatigue, will be collected.	24 weeks