Intervention Programs and Outcomes for Managing Behavioral Problems in Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Client-Related Burnout (Copenhagen Burnout Inventory, Professional Caregivers)
研究概览
简要总结
The goal of this clinical trial is to learn whether a brief, digitally-supported mindfulness program can reduce caregiver burnout in professional caregivers (such as nurses, case managers, and care workers) and informal family caregivers in Taiwan.
The main questions it aims to answer are:
Does the mindfulness program reduce personal and work-related burnout among professional caregivers?
Does the mindfulness program reduce caregiver burden among informal family caregivers?
Researchers compared an immediate-intervention group with a wait-list control group to see if those who received the program earlier experienced greater improvements.
Participants were asked to:
Join five weekly 90-minute live online classes led by an instructor.
Practice daily 10-minute guided mindfulness sessions using the AIZEN digital platform.
Complete questionnaires about stress and caregiver burden at three time points: baseline (T1), after the 5-week program (T2), and 5-week follow-up (T3).
详细描述
This study was a randomized, stratified, wait-list-controlled pilot clinical trial conducted in Taiwan to evaluate the feasibility and preliminary efficacy of a digitally-supported mindfulness program for caregivers.
Participants were randomized 1:1 to either:
Immediate-intervention group (received the 5-week program immediately after randomization), or
Wait-list control group (received the same program after completing their post-intervention assessment at 5 weeks).
Participants were stratified by caregiver type (professional vs. informal), age (younger vs. older than the sample median), and perceived stress level (low vs. high). Randomization was computer-generated and implemented independently of outcome assessment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Currently engaged in paid professional caregiving (e.g., nurse, care worker, case manager) or unpaid informal/family caregiving
- •Able to attend weekly online sessions via Microsoft Teams
- •Willing to complete web-based questionnaires
- •Willing to undertake at least 10 minutes of daily mindfulness practice
- •No prior meditation experience within the three months preceding recruitment
排除标准
- •Did not meet the definition of caregiver (professional or informal)
- •Prior meditation practice within the three months before recruitment
- •Unwilling or unable to provide written informed consent
研究组 & 干预措施
Immediate Meditation Intervention
Participants received a 5-week digitally supported mindfulness program immediately after randomization. The program included five weekly 90-minute live online classes led by an instructor and daily guided mindfulness practice (about 10 minutes per day) using the AIZEN digital platform, with automated reminders delivered via the LINE messaging service.
干预措施: Mindfulness-Based Digital Intervention (AIZEN Program) (Behavioral)
Wait-list Control
Participants were assigned to a wait-list control condition and did not receive the intervention during the first 5 weeks after randomization. After completing post-intervention assessments at Week 5, they received the identical 5-week mindfulness program, consisting of weekly 90-minute live online classes and daily guided mindfulness practice with the AIZEN platform.
结局指标
主要结局
Change in Client-Related Burnout (Copenhagen Burnout Inventory, Professional Caregivers)
时间窗: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
Client-related burnout was measured using the Chinese version of the Copenhagen Burnout Inventory (CBI). This subscale consists of 6 items that assess exhaustion specifically attributed to interactions with care recipients or clients. Each item is scored on a 5-point scale (0 = "never" to 100 = "always"), and the subscale score is calculated as the mean of all items, with higher scores indicating greater burnout.
Change in Personal Burnout (Copenhagen Burnout Inventory, Professional Caregivers)
时间窗: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
Personal burnout was measured using the Chinese version of the Copenhagen Burnout Inventory (CBI). This subscale includes 5 items that assess general physical and psychological exhaustion. Each item is scored on a 5-point scale (0 = "never" to 100 = "always"), and the subscale score is calculated as the mean of all items, with higher scores indicating greater burnout.
Change in Work-Related Burnout (Copenhagen Burnout Inventory, Professional Caregivers)
时间窗: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
Work-related burnout was measured using the Chinese version of the Copenhagen Burnout Inventory (CBI). This subscale consists of 5 items that assess exhaustion specifically attributed to work demands. Each item is scored on a 5-point scale (0 = "never" to 100 = "always"), and the subscale score is calculated as the mean of all items, with higher scores indicating greater burnout.
次要结局
- Change in Caregiver Burden (Zarit Burden Interview, Informal Caregivers)(Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10))