Ecological Momentary Intervention for Stroke Caregivers' Psychological Support

Stroke Clinical Trial

Official title:

Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936828
• Other study ID #: 17617620
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: The University of Hong Kong
• Contact: Jung Jae LEE
• Phone: +85239176971
• Email: leejay[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed trial aims to evaluate the effectiveness of internet-delivered cognitive behavioural therapy (iCBT) based ecological momentary intervention (EMI) for psychological well-being in stroke family caregivers.

Description:

Many stroke patients require long-term care in the community. In Hong Kong (HK), most stroke caregivers in the community are family members, and many require psychological support for caregiver stress. However, these caregivers have difficulties accessing existing centre-based services due to varying work and care responsibilities, and therefore require alternative support services to meet their unique needs and schedules. Evidence shows that internet-delivered cognitive behavioural therapy (iCBT) is effective in managing psychological distress including depressive symptoms, especially when guided by healthcare professionals. Ecological momentary intervention (EMI) is an innovative and cost-effective intervention 'framework' that utilises mobile messages to deliver personalised psychological interventions. The proposed trial aims to deliver iCBT-based EMI through instant messaging applications (e.g. WhatsApp) to provide personalised and real-time psychological support led by nurses. Screened stroke caregivers with Patient Health Questionnaire-9 (PHQ-9) scores ranging from 5 to 19 (mild to moderately severe depressive symptoms) will be recruited from community centres, rehabilitation centres and outpatient clinics in HK. They will then be individually randomised into the Intervention group (n=128) or Control group (n=128). The Intervention group will receive the iCBT-based EMI for 12 weeks, which includes instant messages sent at the times and frequencies of the participants' choosing, and chat-based psychological support led by nurses to enhance effects of iCBT through real-time counselling and practical advice. The control group will only receive instant messages on general mental health information and reminders to participate in follow-up surveys. The primary outcome is PHQ-9 scores at 24 weeks. Secondary outcomes will include anxiety, perceived stress, caregiver burden, caring experience, spiritual well-being and quality-of-daily-life. We will strictly follow the CONSORT-EHEALTH checklist. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI. The intervention will be highly applicable for all caregivers requiring psychological support and will be one step further in meeting the World Health Organization's recommendations in supporting caregivers in the context of global ageing populations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary family caregiver of stroke patient (modified Barthel Index [mBI] <15; usually represent moderate disability)
• Able to read and communicate in Chinese
• Aged =18
• Able to use mobile phone text messaging function
• PHQ-9 ranged from 5 to 19

Exclusion Criteria:

• Professional medical personnel and professional carer
• Has provided care for <1 month prior to recruitment
• Has diagnosis of psychiatric disease or is currently taking psychotropic drug
• PHQ-9 = 20 (i.e., severe depressive symptom)
• Currently participating in any type of psychological intervention (e.g., CBT)

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Depression
• Depressive Symptoms
• Mobile Phone Use
• Psychological Distress
• Stroke

Intervention

Other:
• 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	Hong Kong PHAB Association	Hong Kong
Hong Kong	Hong Kong Stroke Association	Hong Kong
Hong Kong	NT West Community Rehabilitation Day Centre	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Southern District Elderly Community Centre	Hong Kong
Hong Kong	The Hong Kong Society for Rehabilitation	Hong Kong
Hong Kong	Tung Wah 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	Caregiver's burden (Zarit Burden Interview [ZBI-4])	A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden	24-week
Secondary	Caring experience (Positive Aspects of Caregiving [PAC])	An 11-item scale with score ranging from 0 to 44, higher scores indicate more positive appraisal of caregiving experience	24-week
Secondary	Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])	An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being	24-week
Secondary	Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])	A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life	24-week