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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG087216-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Empathy Training | Experimental | 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) |
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| Group 2: Control Condition | Other | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Empathy Training | Behavioral | Participants will engage in a mentalization activity by captioning photos of their care recipients, reflecting on what the care recipient might be thinking or feeling. Over 10 days, caregivers will take 3-5 daily pictures of their care recipient and caption each with descriptive text representing the recipient's inner voice. This task encourages caregivers to consider the care recipient's perspective and motivations behind their behavior or emotional experiences. Photos will be shared securely via encrypted email. Utilizing accessible smartphone technology, the study allows caregivers to capture and reflect on meaningful moments with their care recipients |
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Scale score | 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. | Baseline, immediately post-training (10-Day) , 6 months post-training |
| The Center for Epidemiological Studies Depression (CESD) Scale score | 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. | Baseline, immediately post-training (10-Day), 6 months post-training |
| The State/Trait Anxiety Index (STAI) score | 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. | Baseline, immediately post-training (10-Day), 6 months post-training |
| Perspective-taking subscale if the Interpersonal Reactivity Index (IRI) | The Perspective-Taking scale of the IRI ranges from 0-28, and higher scores are a better outcome | Baseline, immediately post-training (10-Day), 6 months post-training |
| Dyadic Relationship Scale score | The Dyadic Relationship Scale ranges from 0-33 and higher scores are a worse outcome. | Baseline, immediately post-training (10-Day), 6 months post-training |
| IL-6 levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Rilling, PhD | Contact | 404-727-3062 | jrillin@emory.edu | |
| Kenneth Hepburn, PhD | Contact | 404-712-9286 | khepbur@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| James Rilling, PhD | Emory College of Arts & Sciences | Principal Investigator |
| Kenneth Hepburn, PhD | Emory School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alter | Recruiting | Atlanta | Georgia | 30302 | United States |
All behavioral, neuroimaging, and inflammation biomarker data will be preserved and shared. Photo captions will be shared without the photographs. In addition, basic participant demographics and ID numbers will be provided.
Data will be made available no later than the time of an associated publication or the end of the performance period, whichever comes first
Open Science Framework
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D007854 | Lead |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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Using a crossover design, caregivers will be randomized to either cognitive empathy training (n=59) or a control condition (n=59). Neuroimaging, questionnaire, and biomarker data will be collected before the 10-day training, immediately after the training, and six months after. At the 6 month visit, participants will cross over to the other treatment
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| Control Condition | Behavioral | In the control condition, participants will be asked to take 3-5 daily photographs of nature over 10 days. They will be asked to caption each photo with a description of what they see. This exercise will involve many of the same activities as the cognitive empathy training, except that participants will not be mentalizing or taking the the perspective of their PLWD or anyone else. |
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| Pre and post intervention blood spot collection | Procedure | At their initial study visit, participants will provide a blood spot sample for measurement of C-reactive protein, pro-inflammatory cytokines and Epstein-Barr virus antibody titers. |
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| Pre and post intervention MRI session | Procedure | In this study, caregivers will be positioned in a Siemens Trio 3T MRI scanner for functional imaging. They will view images of their care recipient care recipient, other similar care recipients care recipient, and photographs of friends or family members, pressing a button each time they see their care recipient care recipient's photo to monitor attention. The task involves viewing eight photos of four individuals with happy and neutral expressions, followed by rest periods. This sequence repeats five times, with each stimulus presented for 5 seconds and inter-trial intervals of 2, 3, or 4 seconds, totaling 11 minutes and 15 seconds. A subsequent 10-minute diffusion-weighted scan will assess brain white matter integrity, using 60 diffusion directions. All scans will be completed within 40 minutes. |
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Cytokine (Measure of inflammation) |
| Baseline, immediately post-training (10-Day), 6 months post-training |
| IL-10 levels | Cytokine (Measure of inflammation) | Baseline, immediately post-training (10-Day), 6 months post-training |
| TNF-α levels | Cytokine (Measure of inflammation) | Baseline, immediately post-training (10-Day), 6 months post-training |
| Epstein-Barr virus antibody titers | Measure of immune system functioning | Baseline, immediately post-training (10-Day), 6 months post-training |
| fMRI activation within dorsomedial prefrontal cortex (DMPFC) for contrast (own person - unknown person) | Measure of activation within one cognitive empathy ROI | Baseline, immediately post-training (10-Day), 6 months post-training |
| fMRI activation within precuneus for contrast (own person - unknown person) | Measure of activation within one cognitive empathy ROI | Baseline, immediately post-training (10-Day), 6 months post-training |
| fMRI activation within temporo-parietal junction for contrast (own person - unknown person) | Measure of activation within one cognitive empathy (region of interest) ROI | Baseline, immediately post-training (10-Day), 6 months post-training |
| fMRI activation within ventrolateral prefrontal cortex for contrast (own person - unknown person) | Measure of activation within an emotion regulation ROI | Baseline, immediately post-training (10-Day), 6 months post-training |
| Emory Integrated Memory Care | Recruiting | Atlanta | Georgia | 30329 | United States |
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| NIA Goizueta Alzheimer's Disease Research Center | Recruiting | Atlanta | Georgia | 30329 | United States |
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| D001523 | Mental Disorders |
| D013057 |
| Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |