An interventional study of iCBT-based EMI in Stroke, Caregiver Burnout and Depressive Symptoms, sponsored by The University of Hong Kong. Completed at 7 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Other
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.
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.
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 256 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.
Other: iCBT-based EMI
Receive general mental health information through instant message.
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.
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
Time frame: 24-week
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24-week
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Jun 2023, 21 months.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 21 months is close to that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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