Cluster Randomized Controlled Trial to Test the Efficacy of a Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
详细描述
Proposed Study:
The investigators propose a 6-week cluster randomized controlled trial to compare the effectiveness of a novel psychosocial intervention for caregivers of older adults in Hong Kong. The intervention is based on Cognitive Behavioral Therapy, lifestyle intervention, and effective communication skills.
Cluster Randomization:
The research team will perform cluster randomization using statistical software and notify the district-based caregiver support units of their group allocations. Randomisation will be first stratified by SES of district-based caregiver support units, then using random permuted blocks via an online computer randomisation system from an independent clinical trials unit. District-based caregiver support units will be randomised into an intervention or control group.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CBT Experimental Group
Group intervention based on Cognitive Behavioral Therapy, lifestyle intervention, and effective communication.
干预措施: Cognitive Behavioral Therapy for Caregivers of Older Adults (Behavioral)
Active Control Group
The session focused on education about lifestyle and communication.
干预措施: Control intervention for Caregivers of Older Adults (Behavioral)
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: 3 months
The PHQ-9 is a self-report instrument used to assess depression symptoms, consisting of nine items that correspond to the diagnostic criteria for major depressive disorder. Participants will rate the frequency of symptoms experienced over the past two weeks, helping to determine the severity of depressive symptoms.
Generalized Anxiety Disorder (GAD-7)
时间窗: 3 months
The GAD-7 is a widely used screening tool that measures the severity of generalized anxiety disorder by assessing the frequency of anxiety symptoms experienced over the past two weeks.
次要结局
- Carer multidimensional assessment tool(3 months)
- Cantonese short version of the Zarit Burden Interview (CZBI)(3 months)
- The World Health Organization Quality of Life (WHOQoL-BREF)(3 months)
- Connor-Davidson Resilience Scale (CD-RISC-25)(3 months)
- Self-Care Self-Efficacy Scale (SCSES-10)(3 months)
研究者
Prof. Vivian W.Q. Lou
Professor
The University of Hong Kong