Clinical trial NCT04936828: Ecological Momentary Intervention for Stroke Caregivers' Psychological Support
Official title: Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Caregiver Burnout
Depressive Symptoms
Psychological Distress
Mobile Phone Use
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 256
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: 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.

Detailed 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.

Eligibility criteria: 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)

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: Caregiver's burden (Zarit Burden Interview [ZBI-4])
timeFrame: 24-week
measure: Caring experience (Positive Aspects of Caregiving [PAC])
timeFrame: 24-week
measure: Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
timeFrame: 24-week
measure: Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
timeFrame: 24-week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong PHAB Association
city: Hong Kong
country: Hong Kong
facility: Hong Kong Stroke Association
city: Hong Kong
country: Hong Kong
facility: NT West Community Rehabilitation Day Centre
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Society for Rehabilitation
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
References: