Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

Study Overview
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Brief Summary
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Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. A recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively. An evidence profile report by the World Health Organization(WHO) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. Therefore, early psychological intervention (EPI) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving. The main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. Internet-delivered cognitive-behavioural therapy (iCBT) is delivered as an ecological momentary intervention (EMI) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.

Official Title
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Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study

Conditions
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Stroke, Caregiver Burden, Mobile Phone Use

Intervention / Treatment
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* Behavioral: iCBT-based EMI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary family caregiver of first-ever stroke patient who has <15 modified Barthel Index(mBI) scores (moderate disability); Caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days; Aged ≥18; Able to read and communicate in Chinese (Cantonese or Putonghua); Able to use mobile phone instant messaging function; and PHQ-9 (depressive symptom) score ranging from 5 to 19 (note. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27) Exclusion Criteria: Caregiver of stroke patient who is admitted to intensive care unit; Professional medical personnel and/or professional carer; Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants; PHQ-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and Currently participating in any type of psychological 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 |
| --- | --- |
| Experimental: Intervention Group<br>Receive iCBT-based EMI with message content, delivery frequency and timing personalised to participants' preferences. | Behavioral: iCBT-based EMI<br>* 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.<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 | 
| Loneliness level (UCLA Loneliness Scale [ULS-8]) | The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness | 24-week | 
| Acceptance and Action Questionnaire-II (AAQ-II) | The total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance | 24-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive-behavioural therapy, ecological momentary intervention, early psychological intervention