StrokeEPINCT05907005
Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers
A study testing iCBT-based EMI in people with Stroke and Caregiver Burden, run by The University of Hong Kong at 5 sites in Hong Kong.
Trial summary
Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Caregiver Burden, Mobile Phone Use
- What is being tested?
- iCBT-based EMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 5 sitesHong Kong
- Study dates
- 24 Jul 2023to 31 Jul 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 of first-ever stroke patient who has <15 modified Barthel Index(mBI) scores (moderate disability);
- Caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days;
- Aged ≥18;
- Able to read and communicate in Chinese (Cantonese or Putonghua);
- Able to use mobile phone instant messaging function; and
- PHQ-9 (depressive symptom) score ranging from 5 to 19 (note. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)
Who cannot join
- Caregiver of stroke patient who is admitted to intensive care unit;
- Professional medical personnel and/or professional carer;
- Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants;
- PHQ-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and
- 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
- Not yet recruiting
Kwong Wah Hospital
Hong Kong
Peter Woo, wym307@ha.org.hk
- Recruiting
Princess Margaret Hospital
Hong Kong
Ryan Chu, 29903205, cmk019@ha.org.hk
- Recruiting
Queen Elizabeth Hospital
Hong Kong
Vivian Kwok, 35064579, bkwyv02@ha.org.hk
- Recruiting
Queen Mary Hospital
Hong Kong
Gary Lau, 22554249, gkklau@hku.hk
- Recruiting
United Christian Hospital
Hong Kong
Mick Yu, 52156783, yuct1@ha.org.hk
About this study
Official title: Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study
Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. A recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively.
An evidence profile report by the World Health Organization(WHO) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. Therefore, early psychological intervention (EPI) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving.
The main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. Internet-delivered cognitive-behavioural therapy (iCBT) is delivered as an ecological momentary intervention (EMI) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.
- Conditions
- Stroke, Caregiver Burden, Mobile Phone Use
- Being tested
- iCBT-based EMI
- Keywords
- Cognitive-behavioural therapy, ecological momentary intervention, early psychological intervention
- Medical subject headings
- Stroke, Caregiver Burden, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT-based EMIBehavioural
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: Behavioral: 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 (4)
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
Loneliness level (UCLA Loneliness Scale [ULS-8])
The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness
Measured: 24-week
Acceptance and Action Questionnaire-II (AAQ-II)
The total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance
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 posted18 Jun 2023
- Study start24 Jul 2023
- Primary completion24 Jul 2025 (estimated)
- Study completion31 Jul 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
- 152 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
- NCT05907005
- Sponsor's protocol ID
- EPI2023
- Acronym
- EPI
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study
- ClinicalTrials.gov ID
- NCT05907005
- Acronym / sponsor ID
- EPI / EPI2023
- Conditions
- Stroke, Caregiver Burden, Mobile Phone Use
- Keywords
- Cognitive-behavioural therapy, ecological momentary intervention, early psychological intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 18 Jun 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.
Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. A recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively.
An evidence profile report by the World Health Organization(WHO) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. Therefore, early psychological intervention (EPI) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving.
The main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. Internet-delivered cognitive-behavioural therapy (iCBT) is delivered as an ecological momentary intervention (EMI) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.
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: 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 (6 listed)
- Primary family caregiver of first-ever stroke patient who has <15 modified Barthel Index(mBI) scores (moderate disability);
- Caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days;
- Aged ≥18;
- Able to read and communicate in Chinese (Cantonese or Putonghua);
- Able to use mobile phone instant messaging function; and
Key exclusion criteria (5 listed)
- Caregiver of stroke patient who is admitted to intensive care unit;
- Professional medical personnel and/or professional carer;
- Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants;
- PHQ-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and
- 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 |
|---|---|---|
| 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. | Behavioural | 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
4 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
Loneliness level (UCLA Loneliness Scale [ULS-8])
Time frame: 24-week
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 24-week
Results and safety
Results are not available in the source record.
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.
5 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 Burden, 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 6 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: status not confirmed, 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 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?
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.