Ecological Momentary Intervention for Stroke Caregivers' Psychological Support
1 other identifier
interventional
256
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Sep 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
First Submitted
Initial submission to the registry
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 11, 2024
July 1, 2024
1.8 years
June 15, 2021
July 10, 2024
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 (6)
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
24-week
Stress level (Perceived Stress Scale [PSS-4])
24-week
Caregiver's burden (Zarit Burden Interview [ZBI-4])
24-week
Caring experience (Positive Aspects of Caregiving [PAC])
24-week
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
24-week
- +1 more secondary outcomes
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 nurse-led real-time chat-based support messages, delivered according to participants' preferences.
Eligibility Criteria
You may qualify if:
- Primary family caregiver of stroke patient (modified Barthel Index \[mBI\] \<15; usually represent moderate disability)
- Able to read and communicate in Chinese
- Aged ≥18
- Able to use mobile phone text messaging function
- PHQ-9 ranged from 5 to 19
You may not qualify if:
- Professional medical personnel and professional carer
- Has provided care for \<1 month prior to recruitment
- 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
June 15, 2021
First Posted
June 23, 2021
Study Start
September 17, 2021
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share