Clinical trial NCT05907005: Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers
Official title: Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Caregiver Burden
Mobile Phone Use
Keywords: Cognitive-behavioural therapy
ecological momentary intervention
early psychological intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
timeFrame: 24-week
Secondary outcomes:
measure: Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
timeFrame: 24-week
measure: Stress level (Perceived Stress Scale [PSS-4])
timeFrame: 24-week
measure: Loneliness level (UCLA Loneliness Scale [ULS-8])
timeFrame: 24-week
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: 24-week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
References: