Integrative Therapeutic Program to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial: a Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 主要终点
- Expressed emotions
研究概览
简要总结
This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes).
详细描述
A dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program can be developed to address EE in caregivers, such as (1) reduce caregivers' EE, (2) reduce caregivers' depressive symptoms, (3) reduce the behaviorally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and (4) improve caregivers' perceived stress from PLwD's BPSD.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •with a high level of expressed emotion as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C);(Kavanagh et al., 1997; Van Humbeeck et al., 2002; Yu et al., 2016)
- •provides care at least 4 hours per day;(Moon & Adams, 2013)
- •consent to participate, and
- •no acute psychiatric illness.
排除标准
- •with a low level (scored lower than 35 on FAS-C) of expressed emotion
- •do not provide consistent or sufficient care (fewer than 4 hours per day) to PLwD
- •do not consent to participate;
- •with comorbid acute psychiatric illness.
研究组 & 干预措施
COPE program
a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes)
干预措施: Caregivers Of dementia Processing Emotions (COPE) program (Behavioral)
Waitlist control
Participants in the waitlist control group, in comparison to those in the intervention group who receive treatment immediately, are placed on a waiting list and receive the same set of intervention sessions after the formal trial. This approach ensures participants have equal opportunity to receive treatment while strengthening the study's validity and overall quality by maximally controlling for potential confounding variables and biases
结局指标
主要结局
Expressed emotions
时间窗: From baseline to 3rd month followup
Family Attitude Scale - Chinese version (FAS-C) will measure caregivers' EE (i.e., criticism and hostility) held towards the PLwD. FAS-C items are rated on a 5-point Likert scale, with higher scores indicating a higher level of EE.(Kavanagh et al., 1997; Van Humbeeck et al., 2002) Its Cronbach's alpha has been reported as 0.95, with evidence of good construct validity
次要结局
- depressive symptoms(From baseline to 3rd month followup)
- BPSD(From baseline to 3rd month followup)
- social dynamics(From baseline to 3rd month followup)
研究者
Shuangzhou Chen
Post doctoral fellow/Principal Investigator
The University of Hong Kong