Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892965
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-05-28
Brief Title:
Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy iCBT for Post-stroke Depression
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Instant Message-delivered Brief Internet-based Cognitive Behavioural Therapy iCBT for Post-stroke Depression a Mixed Method Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 063 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 073 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 eg 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 n80 or Control group n80 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 n20 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None