The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors
1 other identifier
interventional
40
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Oct 2021
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2021
CompletedFirst Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2022
CompletedMay 1, 2023
April 1, 2023
1.2 years
August 3, 2022
April 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
24-week
Secondary Outcomes (4)
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
24-week
Stress level (Perceived Stress Scale [PSS-4])
24-week
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
24-week
Loneliness (UCLA Loneliness Scale [ULS-8])
24-week
Study Arms (2)
Intervention group
EXPERIMENTALReceive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.
Control group
NO INTERVENTIONReceive general mental health information through instant message.
Interventions
Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and real-time chat-based support messages, delivered according to participants' preferences.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hong Kong PHAB Association
Hong Kong, Hong Kong
Hong Kong Stroke Association
Hong Kong, Hong Kong
NT West Community Rehabilitation Day Centre
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
The Hong Kong Society for Rehabilitation
Hong Kong, Hong Kong
Tung Wah Hospital
Hong Kong, Hong Kong
United Christian Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 5, 2022
Study Start
October 4, 2021
Primary Completion
December 23, 2022
Study Completion
December 23, 2022
Last Updated
May 1, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share