Cluster RCT of Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong (NCT06473012) | Clinical Trial Compass
CompletedNot Applicable
Cluster RCT of Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong
Hong Kong255 participantsStarted 2024-09-03
Plain-language summary
The goal of this cluster randomized controlled trial study is to compare the effectiveness of a novel psychosocial intervention based on Cognitive Behavioral Therapy, lifestyle intervention and effective communication skills in caregivers of older adults in Hong Kong. The main question\[s\] it aims to answer are:
What is the impact of the 6-week psychosocial intervention on distress and burden among participants? Participants will participate in a 6-week psychosocial intervention. Researchers will compare the results between the intervention group and the active control group to see if participants in the intervention group have lower distress and burden.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* family member needs to be the identified adult primary caregiver to an older adult aged 60 years old or above who living in the community
* caregiver needs to score \< 50 using the Caregiver Self-Efficacy Scale (CSES-8) which represents significant insufficiency in self-efficacy
* report mild to moderate depressive symptoms: a total score ranged from 5 to 14 using the Patient Health Questionnaire (PHQ-9)
* report mild to moderate anxiety: a total score ranged from 5 to 14 using the Generalized Anxiety Disorder 7-item (GAD-7)
* living in designated clusters in Hong Kong
Exclusion Criteria:
* caregivers diagnosed with Alzheimer's disease or other types of dementia
* older family member with caregiving needs is receiving government-subvented service
* suffering from acute health conditions, such as conditions caused by a virus, infection, injury, misuse of drugs or medications, preventing the provision of caregiving support
* illiterate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.