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Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

Not Applicable
Recruiting
Conditions
Stroke
Caregiver Burden
Mobile Phone Use
Interventions
Behavioral: iCBT-based EMI
Registration Number
NCT05907005
Lead Sponsor
The University of Hong Kong
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
152
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention GroupiCBT-based EMIReceive iCBT-based EMI with message content, delivery frequency and timing personalised to participants' preferences.
Primary Outcome Measures
NameTimeMethod
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])24-week

A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom

Secondary Outcome Measures
NameTimeMethod
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])24-week

A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms

Stress level (Perceived Stress Scale [PSS-4])24-week

A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress

Loneliness level (UCLA Loneliness Scale [ULS-8])24-week

The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness

Acceptance and Action Questionnaire-II (AAQ-II)24-week

The total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance

Trial Locations

Locations (5)

Kwong Wah Hospital

🇭🇰

Hong Kong, Hong Kong

Princess Margaret Hospital

🇭🇰

Hong Kong, Hong Kong

Queen Elizabeth Hospital

🇭🇰

Hong Kong, Hong Kong

Queen Mary Hospital

🇭🇰

Hong Kong, Hong Kong

United Christian Hospital

🇭🇰

Hong Kong, Hong Kong

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