StrokeNCT05952245
Instant Message-delivered Cognitive Behavioural Therapy for Insomnia (CBT-I)Stroke Caregivers
A study testing iCBTI-based EMI and Education-based EMI in people with Stroke and Insomnia, run by The University of Hong Kong at 5 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Insomnia, Depressive Symptoms
- What is being tested?
- iCBTI-based EMI and Education-based EMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesHong Kong
- Study dates
- 1 Dec 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Hong Kong5 sites, 5 recruiting
- Recruiting
Hong Kong PHAB Association
Hong Kong
Gary Lau, 24268338, garypau@hkphab.org.hk
- Recruiting
Hong Kong Stroke Association
Hong Kong
Ming Chui, 23078257, hk_stroke_a@yahoo.com
- Recruiting
NT West Community Centre
Hong Kong
So, 24569577, ncrc.sw@naac.org.hk
- Recruiting
Queen Mary Hospital
Hong Kong
Gary Lau, 22554249, gkklau@hku.hk
- Recruiting
The Hong Kong Society for Rehabilitation
Hong Kong
Mike Cheung, 22056336, mike.cheung@rehabsociety.org.hk
About this study
Official title: The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) in Stroke Family Caregivers: a Mixed Method Study
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.
Read the 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
- Being tested
- iCBTI-based EMI, Education-based EMI
- Medical subject headings
- Stroke, Sleep Initiation and Maintenance Disorders, Depression, Caregiver Burden, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBTI-based EMIBehavioural
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 EMIBehavioural
Stroke and brief sleep hygiene education with chat-based support on the topics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receiving CBT-I based EMI messages. Receives: Behavioral: iCBTI-based EMI |
| Control Group | Active comparator | Receiving education-based EMI messages. Receives: Behavioral: Education-based EMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Insomnia Severity Index (ISI)
A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
Measured: 24 weeks
Secondary outcomes (15)
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
Measured: 24 weeks
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
Measured: 24 weeks
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
Measured: 24 weeks
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
Measured: 24 weeks
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).
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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).
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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
Measured: 24 weeks
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.
Measured: 24 weeks
Adverse events
Feedback on adverse events related to the iCBT-I intervention, such as fatigue, will be collected.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952245
- Sponsor's protocol ID
- CBTI2023
- Status last verified
- Jun 2023
- First submitted
- 11 Jul 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instant Message-delivered Brief Cognitive Behavioural Therapy for Insomnia (CBT-I) in Stroke Family Caregivers: a Mixed Method Study
- ClinicalTrials.gov ID
- NCT05952245
- Acronym / sponsor ID
- CBTI2023
- Conditions
- Stroke, Insomnia, Depressive Symptoms, Caregiver Burnout, Psychological Distress, Mobile Phone Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: iCBTI-based EMIReceiving CBT-I based EMI messages. |
| Control Group | Active comparator | Behavioral: Education-based EMIReceiving education-based EMI messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBTI-based EMIIncluding 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). | Behavioural | Intervention Group |
| Education-based EMIStroke and brief sleep hygiene education with chat-based support on the topics. | Behavioural | Control Group |
Primary outcome
Sleep Condition Indicator (SCI)
Time frame: 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.
Insomnia Severity Index (ISI)
Time frame: 24 weeks
A 7-item scale with scoring ranging from 0-28, a higher score indicate more severe insomnia symptoms
15 secondary outcomes
Sleep quality (Pittsburgh Sleep Quality Index [PSQI])
Time frame: 24 weeks
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]):
Time frame: 24 weeks
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
Time frame: 24 weeks
Caregiver's burden (Zarit Burden Interview [ZBI-4])
Time frame: 24 weeks
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Time frame: 24 weeks
Positive experiences from caregiving (Positive Aspect of Caregiving [PAC])
Time frame: 24 weeks
Caregiving self-efficacy (Caregiving Self-Efficacy Scale [CSES-8])
Time frame: 24 weeks
Sleep parameters (Consensus Sleep Diary Core Version)
Time frame: 24 weeks
Dysfunctional Beliefs and attitudes about Sleep (Dysfunctional Beliefs and attitudes about Sleep [DBAS])
Time frame: 24 weeks
Sleep hygiene statue (Sleep Hygiene Index [SHI])
Time frame: 24 weeks
Sleep-related behavior (Chinese short-form of the sleep-related behavior questionnaire [SRBQ-SF])
Time frame: 24 weeks
State of sleep effort (Glasgow Sleep Effort Scale [GSES])
Time frame: 24 weeks
Sleep-related quality of life (Glasgow Sleep Impact Index [GSII])
Time frame: 24 weeks
Feedback on iCBT-I intervention
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBTI-based EMI and Education-based EMI in people with Stroke and Insomnia, run by The University of Hong Kong at 5 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Jae LEE (+852 3917 6971, leejay@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Condition Indicator (SCI) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.