Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers

Stroke Clinical Trial

— EPI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05907005
• Other study ID #: EPI2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2023
• Source: The University of Hong Kong
• Contact: Jung Jae LEE
• Phone: +852 3917 6971
• Email: leejay[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: July 31, 2025
• Est. primary completion date: July 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Mobile Phone Use
• Stroke

Intervention

Behavioral:
• iCBT-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.

Locations

Country	Name	City	State
Hong Kong	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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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