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Clinical Trials/NCT05907005
NCT05907005
Recruiting
Not Applicable

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

The University of Hong Kong5 sites in 1 country152 target enrollmentJuly 24, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
The University of Hong Kong
Enrollment
152
Locations
5
Primary Endpoint
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 24, 2023
End Date
July 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])

Time Frame: 24-week

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

Secondary Outcomes

  • Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])(24-week)
  • Stress level (Perceived Stress Scale [PSS-4])(24-week)
  • Loneliness level (UCLA Loneliness Scale [ULS-8])(24-week)
  • Acceptance and Action Questionnaire-II (AAQ-II)(24-week)

Study Sites (5)

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