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Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05907005
Acronym
EPI
Enrollment
152
Registered
2023-06-18
Start date
2023-07-24
Completion date
2025-07-31
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burden, Mobile Phone Use, Stroke

Keywords

Cognitive-behavioural therapy, ecological momentary intervention, early psychological intervention

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.

Interventions

BEHAVIORALiCBT-based EMI

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])24-weekA 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom

Secondary

MeasureTime frameDescription
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])24-weekA 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-weekA 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-weekThe 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-weekThe total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance

Countries

Hong Kong

Contacts

Primary ContactJung Jae LEE
leejay@hku.hk+852 3917 6971

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026