Effect of Cognitive Empathy Training on Dementia Caregivers
- Conditions
- Caregivers of People Living With DementiaDementia
- Registration Number
- NCT06650527
- Lead Sponsor
- Emory University
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method fMRI activation within ventrolateral prefrontal cortex for contrast (own person - unknown person) Baseline, immediately post-training (10-Day), 6 months post-training Measure of activation within an emotion regulation ROI
Zarit Burden Scale score 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 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 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) 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 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 Baseline, immediately post-training (10-Day), 6 months post-training Cytokine (Measure of inflammation)
IL-10 levels Baseline, immediately post-training (10-Day), 6 months post-training Cytokine (Measure of inflammation)
TNF-α levels Baseline, immediately post-training (10-Day), 6 months post-training Cytokine (Measure of inflammation)
Epstein-Barr virus antibody titers 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) 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) 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) Baseline, immediately post-training (10-Day), 6 months post-training Measure of activation within one cognitive empathy (region of interest) ROI
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Alter
🇺🇸Atlanta, Georgia, United States
Emory Integrated Memory Care
🇺🇸Atlanta, Georgia, United States
NIA Goizueta Alzheimer's Disease Research Center
🇺🇸Atlanta, Georgia, United States