Mobile Message Intervention for Stroke Caregivers' Psychological Support

Study Overview
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Brief Summary
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The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress.

Detailed Description
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75% of stroke caregivers report severe caregiver burdens, with 60% of stroke caregivers reporting at least one depressive symptom in Hong Kong. However, caregivers can experience difficulties in accessing and fully utilising existing services due to the varying types of care needs and its intensities amongst stroke survivors. Ecological momentary intervention (EMI) as an innovative and personalised intervention has shown great potential in supporting psychological well-being; yet, there are no studies on using EMI for the caregivers' psychological support. The proposed trial aims to reduce stroke caregivers' psychological distress by delivering EMI through instant messaging applications to provide personalised and real-time support led by healthcare professionals. Stroke caregivers screened by Patient Health Questionnaire-9 (PHQ-9) with scores ranging from 5 to 19 will be recruited from multiple sites including community centres, rehabilitation centres and outpatient clinics in public hospitals in Hong Kong, and individually randomised into the intervention group (n=20) or control group (n=20). The intervention group will receive the personalised instant messages for 4 weeks. The control group will receive general health information and regular messages reminding them to participate in follow-up surveys. The primary outcome will be the score of PHQ-9 at 4 weeks. Secondary outcomes will include anxiety, perceived stress, and caregiver burden.

Official Title
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The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial

Conditions
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Stroke, Caregiver Burnout, Mobile Phone Use, Depressive Symptoms, Psychological Distress

Intervention / Treatment
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* Other: Ecological Momentary Intervention (EMI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary family caregiver of stroke survivor Able to read and communicate in Chinese Able to use mobile phone text messaging function PHQ-9 ranged from 5 to 19 Exclusion Criteria: Professional medical personnel and care assistants 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 support intervention

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 |
| --- | --- |
| Active Comparator: Intervention group<br>receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group. | Other: Ecological Momentary Intervention (EMI)<br>* Using the messaging function of mobile devices, EMI offers a framework to deliver health information to the target population, corresponding to each individual's demands in terms of type (e.g., photo, text and/or voice message), timing, duration, and frequency of the messages, which are different to the features from other interventions<br>|
| No Intervention: Control group<br>receive general health information through a mobile message. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks | Patient Health Questionnaire (PHQ-9) Scale: PHQ-9 is a scale for screening depression in primary care. It consists of 9 items with 4 likert scale. Score range is from 0 to 27 (higher score = higher severity of depressive symptom). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks | Generalized Anxiety Disorder-7 (GAD-7) Scale: GAD-7 is a scale for screening anxiety in primary care. It consists of 7 items with 4 likert scale. Score range is from 0 to 21 (higher score = higher severity of anxiety symptom). | 4 weeks | 
| Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks | Perceived Stress Scale (PSS-4); PSS-4 is a scale for screening stress level. It consists of 4 items with 5 likert scale. Score range is from 0 to 16 (higher score = higher severity of stress). | 4 weeks | 
| Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks | Burden Interview-4 (ZBI-4) Scale: ZBI-4 is a scale for screening carer's burdens. It consists of 4 items with 5 likert scale. Score range is from 0 to 16 (higher score = higher severity of caring burden). | 4 weeks |