StrokeNCT05490069
The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
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
The proposed pilot trial aims to evaluate the feasibility of iCBT based EMI, which is a real-time, real-world, personalised and cost-effective approach, for stroke survivors' psychological well-being. 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
- 40 participants
- Where
- 7 sitesHong Kong
- Study dates
- 4 Oct 2021to 23 Dec 2022
- 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 text messaging function on mobile phones
- MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)
- Discharged home from hospital within preceding 6 months
- PHQ-9 (depressive symptom) score range from 5 to 19 (cf. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)
Who cannot join
- Currently receiving active stroke care in acute or post-acute inpatient settings
- 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
The proposed pilot trial aims to evaluate the feasibility of iCBT based EMI, which is a real-time, real-world, personalised and cost-effective approach, for stroke survivors' psychological well-being.
- 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 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
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
Loneliness (UCLA Loneliness Scale [ULS-8])
An 8-item scale with score ranging from 8 to 32, higher scores indicate higher level 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 posted5 Aug 2022
- Study start4 Oct 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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
- 40 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
- NCT05490069
- Sponsor's protocol ID
- 20-526
- Status last verified
- Apr 2023
- First submitted
- 3 Aug 2022
- Last updated
- 1 May 2023
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
- ClinicalTrials.gov ID
- NCT05490069
- Acronym / sponsor ID
- 20-526
- Conditions
- Stroke, Depressive Symptoms, Mobile Phone Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 5 Aug 2022 (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 pilot trial aims to evaluate the feasibility of iCBT based EMI, which is a real-time, real-world, personalised and cost-effective approach, for stroke survivors' psychological well-being.
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 (7 listed)
- Diagnosis of stroke (ICD-10 codes: I60-I69)
- Aged ≥18
- Able to read and communicate in Chinese (Cantonese or Putonghua)
- Able to use text messaging function on mobile phones
- MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)
Key exclusion criteria (4 listed)
- Currently receiving active stroke care in acute or post-acute inpatient settings
- 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 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
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
Time frame: 24-week
Loneliness (UCLA Loneliness Scale [ULS-8])
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 1 May 2023.
- 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 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 7 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: finished, as of the sponsor's last update on 1 May 2023. 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 1 May 2023.