StrokeNCT05892965
Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression
A study testing iCBT-based EMI in people with Stroke and Depressive Symptoms, run by The University of Hong Kong at 7 sites in Hong Kong.
Trial summary
Around one third of stroke survivors develop depression at any point of time following the stroke event. Post-stroke depression (PSD) is associated with negative care outcomes including poorer function, longer hospital stays, increased outpatient and inpatient clinic use, and higher mortality rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Depressive Symptoms, Mobile Phone Use
- What is being tested?
- iCBT-based EMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 7 sitesHong Kong
- Study dates
- 1 May 2023to Jun 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
- Diagnosis of stroke (ICD-10 codes: I60-I69);
- Aged ≥18;
- Able to read and communicate in Chinese (Cantonese or Putonghua);
- Able to use the text or voice messaging function on smartphone;
- MoCA 5-minute Protocol (cognitive screen) ≥14;
- Community-dwelling
- Less than 1 year after stroke event;
- 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
- Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants
- PHQ-9 ≥ 20 (i.e., severe depressive symptom)
- Currently participating in any type of psychological intervention
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Hong Kong7 sites, 7 recruiting
- Recruiting
Hong Kong PHAB Association
Hong Kong
Henry Chan, 37055328, henrychan@hkphab.org.hk
- Recruiting
Hong Kong Stroke Association
Hong Kong
Wendy, 23078257, hk_stroke_a@yahoo.com
- Not yet recruiting
NT West Community Rehabilitation Day 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, 25343349, mike.cheung@rehabsociety.org.hk
- Recruiting
Tung Wah Hospital
Hong Kong
Tsz Kin Kwok, 28597500, kwoktk@ha.org.hk
- Recruiting
United Christian Hospital
Hong Kong
Mick Yu, 52156783, yuct1@ha.org.hk
About this study
Official title: Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression: a Mixed Method Study
Around one third of stroke survivors develop depression at any point of time following the stroke event. Post-stroke depression (PSD) is associated with negative care outcomes including poorer function, longer hospital stays, increased outpatient and inpatient clinic use, and higher mortality rate. In Hong Kong (HK), the prevalence of PSD within the hospital setting was 36%, and up to 68% in the community setting. However, PSD is seldom addressed in either settings in HK and elsewhere. Meta-analyses reported the effectiveness of Internet-based cognitive behavioural therapy (iCBT), particularly when guided by therapists (d = 0.63). Personalised and synchronous instant message-based intervention guided by therapists is an emerging form of psychological intervention. While such intervention showed medium to large effect (Hedges' g = 0.73) on negative psychological distress episodes including depression, no study has investigated its effect on PSD. The proposed study aims to 1) investigate the effect of therapist-guided brief iCBT delivery through instant messaging applications (e.g. WhatsApp and WeChat) to provide personalised and synchronous PSD support and 2) understand the experience of and compliance with the intervention. 160 community-dwelling stroke survivors with Patient Health Questionnaire-9 (PHQ-9) scores ranging from 5 to 19 indicating mild to moderate depressive symptoms will be recruited and then individually randomised into the Intervention group (n=80) or Control group (n=80). Intervention group will receive 1) instant message-delivered brief iCBT for 3 months at participants' chosen times and frequencies, and 2) therapist-led text or voice message-based PSD support to enhance the effects of iCBT through real-time counselling and practical advice. Control group will only receive messages on general mental health information and reminders to participate in follow-up surveys. The primary outcome is PHQ-9 score at 6 months. Secondary outcomes will include anxiety (GAD-7), perceived stress (PSS-4), loneliness (ULS-8), and quality of life (EQ-5D-5L) at 6 months. The study will strictly follow the CONSORT-EHEALTH checklist. Post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the intervention (n≈20) respectively. This study will provide the first and practical evidence on the effectiveness of instant message-delivered brief iCBT intervention in addressing PSD in HK and beyond.
- Conditions
- Stroke, Depressive Symptoms, Mobile Phone Use
- Being tested
- iCBT-based EMI
- Medical subject headings
- Stroke, 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 (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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 May 2023
- Primary completionDec 2024 (estimated)
- Study completionJun 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
- 160 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
- NCT05892965
- Sponsor's protocol ID
- 27615721
- Status last verified
- Jul 2024
- First submitted
- 28 May 2023
- 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
- Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy (iCBT) for Post-stroke Depression: a Mixed Method Study
- ClinicalTrials.gov ID
- NCT05892965
- Acronym / sponsor ID
- 27615721
- Conditions
- Stroke, Depressive Symptoms, Mobile Phone Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 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.
Around one third of stroke survivors develop depression at any point of time following the stroke event. Post-stroke depression (PSD) is associated with negative care outcomes including poorer function, longer hospital stays, increased outpatient and inpatient clinic use, and higher mortality rate. In Hong Kong (HK), the prevalence of PSD within the hospital setting was 36%, and up to 68% in the community setting. However, PSD is seldom addressed in either settings in HK and elsewhere. Meta-analyses reported the effectiveness of Internet-based cognitive behavioural therapy (iCBT), particularly when guided by therapists (d = 0.63). Personalised and synchronous instant message-based intervention guided by therapists is an emerging form of psychological intervention. While such intervention showed medium to large effect (Hedges' g = 0.73) on negative psychological distress episodes including depression, no study has investigated its effect on PSD. The proposed study aims to 1) investigate the effect of therapist-guided brief iCBT delivery through instant messaging applications (e.g. WhatsApp and WeChat) to provide personalised and synchronous PSD support and 2) understand the experience of and compliance with the intervention. 160 community-dwelling stroke survivors with Patient Health Questionnaire-9 (PHQ-9) scores ranging from 5 to 19 indicating mild to moderate depressive symptoms will be recruited and then individually randomised into the Intervention group (n=80) or Control group (n=80). Intervention group will receive 1) instant message-delivered brief iCBT for 3 months at participants' chosen times and frequencies, and 2) therapist-led text or voice message-based PSD support to enhance the effects of iCBT through real-time counselling and practical advice. Control group will only receive messages on general mental health information and reminders to participate in follow-up surveys. The primary outcome is PHQ-9 score at 6 months. Secondary outcomes will include anxiety (GAD-7), perceived stress (PSS-4), loneliness (ULS-8), and quality of life (EQ-5D-5L) at 6 months. The study will strictly follow the CONSORT-EHEALTH checklist. Post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the intervention (n≈20) respectively. This study will provide the first and practical evidence on the effectiveness of instant message-delivered brief iCBT intervention in addressing PSD in HK and beyond.
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 (8 listed)
- Diagnosis of stroke (ICD-10 codes: I60-I69);
- Aged ≥18;
- Able to read and communicate in Chinese (Cantonese or Putonghua);
- Able to use the text or voice messaging function on smartphone;
- MoCA 5-minute Protocol (cognitive screen) ≥14;
Key exclusion criteria (3 listed)
- Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants
- PHQ-9 ≥ 20 (i.e., severe depressive symptom)
- 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. | 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
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
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Time frame: 24-week
Loneliness level (UCLA Loneliness Scale [ULS-8])
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.
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 Depressive Symptoms, 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 8 inclusion and 3 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Jae LEE (+85239176971, 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; AzTrials last refreshed its copy on 31 Oct 2026.