StrokeNCT04936828
Ecological Momentary Intervention for Stroke Caregivers' Psychological Support
A study testing iCBT-based EMI in people with Stroke and Caregiver Burnout, run by The University of Hong Kong at 7 sites in Hong Kong.
Trial summary
The proposed trial aims to evaluate the effectiveness of internet-delivered cognitive behavioural therapy (iCBT) based ecological momentary intervention (EMI) for psychological well-being in stroke family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Caregiver Burnout, Depressive Symptoms
- What is being tested?
- iCBT-based EMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 7 sitesHong Kong
- Study dates
- 17 Sep 2021to 30 Jun 2023
- 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 of stroke patient (modified Barthel Index [mBI] <15; usually represent moderate disability)
- Able to read and communicate in Chinese
- Aged ≥18
- Able to use mobile phone text messaging function
- PHQ-9 ranged from 5 to 19
Who cannot join
- Professional medical personnel and professional carer
- Has provided care for <1 month prior to recruitment
- Has diagnosis of psychiatric disease or is currently taking psychotropic drug
- PHQ-9 ≥ 20 (i.e., severe depressive symptom)
- Currently participating in any type of psychological intervention (e.g., CBT)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Hong Kong7 sites
Hong Kong PHAB Association
Hong Kong
Hong Kong Stroke Association
Hong Kong
NT West Community Rehabilitation Day Centre
Hong Kong
Queen Mary Hospital
Hong Kong
The Hong Kong Society for Rehabilitation
Hong Kong
Tung Wah Hospital
Hong Kong
United Christian Hospital
Hong Kong
About this study
Official title: Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Randomised Controlled Trial
The proposed trial aims to evaluate the effectiveness of internet-delivered cognitive behavioural therapy (iCBT) based ecological momentary intervention (EMI) for psychological well-being in stroke family caregivers.
Read the detailed description
Many stroke patients require long-term care in the community. In Hong Kong (HK), most stroke caregivers in the community are family members, and many require psychological support for caregiver stress. However, these caregivers have difficulties accessing existing centre-based services due to varying work and care responsibilities, and therefore require alternative support services to meet their unique needs and schedules. Evidence shows that internet-delivered cognitive behavioural therapy (iCBT) is effective in managing psychological distress including depressive symptoms, especially when guided by healthcare professionals. Ecological momentary intervention (EMI) is an innovative and cost-effective intervention 'framework' that utilises mobile messages to deliver personalised psychological interventions. The proposed trial aims to deliver iCBT-based EMI through instant messaging applications (e.g. WhatsApp) to provide personalised and real-time psychological support led by nurses. Screened stroke caregivers with Patient Health Questionnaire-9 (PHQ-9) scores ranging from 5 to 19 (mild to moderately severe depressive symptoms) will be recruited from community centres, rehabilitation centres and outpatient clinics in HK. They will then be individually randomised into the Intervention group (n=128) or Control group (n=128). The Intervention group will receive the iCBT-based EMI for 12 weeks, which includes instant messages sent at the times and frequencies of the participants' choosing, and chat-based psychological support led by nurses to enhance effects of iCBT through real-time counselling and practical advice. The control group will only receive instant messages on general mental health information and reminders to participate in follow-up surveys. The primary outcome is PHQ-9 scores at 24 weeks. Secondary outcomes will include anxiety, perceived stress, caregiver burden, caring experience, spiritual well-being and quality-of-daily-life. We will strictly follow the CONSORT-EHEALTH checklist. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI. The intervention will be highly applicable for all caregivers requiring psychological support and will be one step further in meeting the World Health Organization's recommendations in supporting caregivers in the context of global ageing populations.
- Being tested
- iCBT-based EMI
- Medical subject headings
- Stroke, Caregiver Burden, Depression, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT-based EMIOther
Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and nurse-led real-time chat-based support messages, delivered according to participants' preferences.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences. Receives: Other: iCBT-based EMI |
| Control group | No intervention | Receive general mental health information through instant message. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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-week
Secondary outcomes (6)
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 symptoms
Measured: 24-week
Stress level (Perceived Stress Scale [PSS-4])
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress
Measured: 24-week
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-week
Caring experience (Positive Aspects of Caregiving [PAC])
An 11-item scale with score ranging from 0 to 44, higher scores indicate more positive appraisal of caregiving experience
Measured: 24-week
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being
Measured: 24-week
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life
Measured: 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start17 Sep 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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
- 256 participants (actual)
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
- NCT04936828
- Sponsor's protocol ID
- 17617620
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2021
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04936828
- Acronym / sponsor ID
- 17617620
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Jun 2021 (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 evaluate the effectiveness of internet-delivered cognitive behavioural therapy (iCBT) based ecological momentary intervention (EMI) for psychological well-being in stroke family caregivers.
Detailed description
Many stroke patients require long-term care in the community. In Hong Kong (HK), most stroke caregivers in the community are family members, and many require psychological support for caregiver stress. However, these caregivers have difficulties accessing existing centre-based services due to varying work and care responsibilities, and therefore require alternative support services to meet their unique needs and schedules. Evidence shows that internet-delivered cognitive behavioural therapy (iCBT) is effective in managing psychological distress including depressive symptoms, especially when guided by healthcare professionals. Ecological momentary intervention (EMI) is an innovative and cost-effective intervention 'framework' that utilises mobile messages to deliver personalised psychological interventions. The proposed trial aims to deliver iCBT-based EMI through instant messaging applications (e.g. WhatsApp) to provide personalised and real-time psychological support led by nurses. Screened stroke caregivers with Patient Health Questionnaire-9 (PHQ-9) scores ranging from 5 to 19 (mild to moderately severe depressive symptoms) will be recruited from community centres, rehabilitation centres and outpatient clinics in HK. They will then be individually randomised into the Intervention group (n=128) or Control group (n=128). The Intervention group will receive the iCBT-based EMI for 12 weeks, which includes instant messages sent at the times and frequencies of the participants' choosing, and chat-based psychological support led by nurses to enhance effects of iCBT through real-time counselling and practical advice. The control group will only receive instant messages on general mental health information and reminders to participate in follow-up surveys. The primary outcome is PHQ-9 scores at 24 weeks. Secondary outcomes will include anxiety, perceived stress, caregiver burden, caring experience, spiritual well-being and quality-of-daily-life. We will strictly follow the CONSORT-EHEALTH checklist. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI. The intervention will be highly applicable for all caregivers requiring psychological support and will be one step further in meeting the World Health Organization's recommendations in supporting caregivers in the context of global ageing populations.
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 | Other: iCBT-based EMIReceive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences. |
| Control group | No intervention | –Receive general mental health information through instant message. |
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 of stroke patient (modified Barthel Index [mBI] <15; usually represent moderate disability)
- Able to read and communicate in Chinese
- Aged ≥18
- Able to use mobile phone text messaging function
- PHQ-9 ranged from 5 to 19
Key exclusion criteria (5 listed)
- Professional medical personnel and professional carer
- Has provided care for <1 month prior to recruitment
- Has diagnosis of psychiatric disease or is currently taking psychotropic drug
- PHQ-9 ≥ 20 (i.e., severe depressive symptom)
- Currently participating in any type of psychological intervention (e.g., CBT)
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 |
|---|---|---|
| iCBT-based EMIConsists of brief iCBT for psychological support (mandatory), stroke care education (optional), and nurse-led real-time chat-based support messages, delivered according to participants' preferences. | Other | Intervention group |
Primary outcome
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
Time frame: 24-week
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
6 secondary outcomes
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
Time frame: 24-week
Stress level (Perceived Stress Scale [PSS-4])
Time frame: 24-week
Caregiver's burden (Zarit Burden Interview [ZBI-4])
Time frame: 24-week
Caring experience (Positive Aspects of Caregiving [PAC])
Time frame: 24-week
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
Time frame: 24-week
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Time frame: 24-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT-based EMI in people with Stroke and Caregiver Burnout, run by The University of Hong Kong at 7 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 5 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: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) (time frame: 24-week). 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 11 Jul 2024.