Effect of Cognitive Empathy Training on Dementia Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- fMRI activation within ventrolateral prefrontal cortex for contrast (own person - unknown person)
研究概览
简要总结
The goal of this project is to investigate the effect of cognitive empathy training on mental health, inflammation, and immune function in caregivers of people living with dementia (PLWD), and to examine the underlying psychological and neurobiological mechanisms.
The primary aim is to establish the effectiveness of cognitive empathy training in improving caregiver mental health and immune function, and in decreasing caregiver inflammation
The secondary aim is to investigate the psychological and neurobiological mechanism by which cognitive empathy training improves caregiver well-being
详细描述
In the U.S., over 7 million people currently live with Alzheimer's disease and related disorders (ADRD), a number projected to exceed 16 million by 2060. Family caregivers, numbering more than 11 million, play a crucial role in managing the care of these individuals, often bearing significant emotional and financial burdens. In 2021, the cost of care for dementia reached $593 billion, with families contributing a substantial portion. Caregivers frequently experience negative mental and physical health impacts due to chronic stress, including increased rates of depression and inflammation. Research indicates that caregiving leads to decreased immune function, with elevated Epstein-Barr virus antibody titers serving as a marker for immune health. Interventions aimed at supporting caregivers, such as psychoeducational programs, have shown benefits, particularly in enhancing coping skills. Additionally, fostering cognitive empathy in caregivers may improve their mental health and the quality of care provided to individuals with dementia, potentially mitigating some of the adverse health effects associated with caregiving stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregivers must live with their care recipient
- •Caregivers must have a Zarit Burden Scale score of 19 or higher
- •Caregivers must have no plans to move their care recipient to an institutional setting within the next year
- •Caregivers must be able to read and write English
- •Care recipient not in hospice
- •Access to a mobile phone that can take and email photographs
排除标准
- •Subjects with a history of seizures or other neurological disorders, alcoholism, or any other substance abuse
- •Subjects with a history of psychiatric illness (excluding depression and anxiety disorders) will also be excluded
- •Subjects with a history of head trauma based on Survey
- •Subjects with MRI contra-indications
研究组 & 干预措施
Group 1: Empathy Training
Participants will be randomly assigned to the empathy training or control condition for 6 months. During the first phase of the study, participants in Group 1 will receive the photo captioning intervention.
At the 6-month time point, participants in Group 1 will crossover to control.
Assessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover) and 12-month (completion)
干预措施: Cognitive Empathy Training (Behavioral)
Group 1: Empathy Training
Participants will be randomly assigned to the empathy training or control condition for 6 months. During the first phase of the study, participants in Group 1 will receive the photo captioning intervention.
At the 6-month time point, participants in Group 1 will crossover to control.
Assessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover) and 12-month (completion)
干预措施: Pre and post intervention blood spot collection (Procedure)
Group 1: Empathy Training
Participants will be randomly assigned to the empathy training or control condition for 6 months. During the first phase of the study, participants in Group 1 will receive the photo captioning intervention.
At the 6-month time point, participants in Group 1 will crossover to control.
Assessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover) and 12-month (completion)
干预措施: Pre and post intervention MRI session (Procedure)
Group 2: Control Condition
During the first phase of the study, participants in Group 2 are controls. At the 6-month time point, participants in Group 2 will crossover and initiate the intervention.
Assessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover), and 12-month (completion)
干预措施: Pre and post intervention MRI session (Procedure)
Group 2: Control Condition
During the first phase of the study, participants in Group 2 are controls. At the 6-month time point, participants in Group 2 will crossover and initiate the intervention.
Assessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover), and 12-month (completion)
干预措施: Control Condition (Behavioral)
Group 2: Control Condition
During the first phase of the study, participants in Group 2 are controls. At the 6-month time point, participants in Group 2 will crossover and initiate the intervention.
Assessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover), and 12-month (completion)
干预措施: Pre and post intervention blood spot collection (Procedure)
结局指标
主要结局
fMRI activation within ventrolateral prefrontal cortex for contrast (own person - unknown person)
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of activation within an emotion regulation ROI
Zarit Burden Scale score
时间窗: Baseline, immediately post-training (10-Day) , 6 months post-training
Zarit Burden Inventory (ZBI) score is a 22-item Likert scale. Each item is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score is obtained by summing all items endorsed. Higher scores indicate greater perceived burden.
The Center for Epidemiological Studies Depression (CESD) Scale score
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.
The State/Trait Anxiety Index (STAI) score
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
Perspective-taking subscale if the Interpersonal Reactivity Index (IRI)
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
The Perspective-Taking scale of the IRI ranges from 0-28, and higher scores are a better outcome
Dyadic Relationship Scale score
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
The Dyadic Relationship Scale ranges from 0-33 and higher scores are a worse outcome.
IL-6 levels
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
IL-10 levels
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
TNF-α levels
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
Epstein-Barr virus antibody titers
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of immune system functioning
fMRI activation within dorsomedial prefrontal cortex (DMPFC) for contrast (own person - unknown person)
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of activation within one cognitive empathy ROI
fMRI activation within precuneus for contrast (own person - unknown person)
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of activation within one cognitive empathy ROI
fMRI activation within temporo-parietal junction for contrast (own person - unknown person)
时间窗: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of activation within one cognitive empathy (region of interest) ROI
次要结局
未报告次要终点
研究者
James K. Rilling
Professor
Emory University