The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Instant Message Intervention for Psychological Well-being Among Stroke Survivors

Conditions
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Stroke, Depressive Symptoms, Mobile Phone Use

Intervention / Treatment
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* Other: iCBT-based EMI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences. | Other: iCBT-based EMI<br>* Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and real-time chat-based support messages, delivered according to participants' preferences.<br>|
| No Intervention: Control group<br>Receive general mental health information through instant message. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 24-week |