Cognitive Empathy Training for Dementia Caregivers

Recruiting at 2 trial locations

Overseen By James Rilling, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Seizures, Neurological disorders, Alcoholism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cognitive empathy training can improve mental health and immune function, and reduce inflammation in those caring for individuals with dementia. Researchers aim to determine if this training benefits caregivers and to understand the biological mechanisms behind its effectiveness. Participants will be divided into two groups: one will receive the training first, while the other will serve as a control before switching roles. Eligible participants should live with the person they care for, experience a significant caregiving burden, speak English, and have a phone capable of taking photos. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance caregiver well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cognitive empathy training is safe for caregivers of people living with dementia?

Studies have shown that cognitive empathy training is generally safe for caregivers. Research indicates that increasing cognitive empathy can enhance caregivers' well-being and reduce stress without major safety concerns. In similar programs, such as the Dementia LiveTM program, caregivers demonstrated improved skills, suggesting these activities are well-received. Notably, there are no specific reports of negative effects linked to this kind of training. This suggests cognitive empathy training is a safe option for those considering participation in such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Empathy Training for dementia caregivers because it emphasizes enhancing interpersonal skills, a unique approach compared to standard pharmaceutical treatments focused on managing symptoms. This training aims to improve caregivers' ability to understand and emotionally connect with those they care for, potentially reducing caregiver stress and improving patient outcomes. Unlike medications, this method offers a non-invasive, skill-based intervention that could lead to more compassionate care and a better quality of life for both caregivers and patients.

What evidence suggests that cognitive empathy training is effective for improving caregiver mental health and immune function?

Research has shown that training in understanding and sharing feelings, known as cognitive empathy training, can benefit those who care for people with dementia. This trial will evaluate the effects of cognitive empathy training, which participants in Group 1 will receive during the first phase. This training can reduce stress and increase empathy. Studies also suggest it might lower inflammation and improve the immune system, both crucial for maintaining health. By focusing on understanding others' feelings, caregivers may find their work less stressful and more fulfilling. This approach could lead to better care for people with dementia and improved well-being for the caregivers. ^{1 6 7 8 9}

Who Is on the Research Team?

Kenneth Hepburn, PhD

Principal Investigator

Emory School of Nursing

James Rilling, PhD

Principal Investigator

Emory College of Arts & Sciences

Are You a Good Fit for This Trial?

This trial is for caregivers of individuals with dementia, including Alzheimer's Disease. Participants should be in good general health and willing to undergo empathy training as well as pre and post intervention assessments like blood spot collection and MRI sessions.

Inclusion Criteria

Caregivers must be able to read and write English

Care recipient not in hospice

Caregivers must live with their care recipient

Exclusion Criteria

Subjects with a history of seizures or other neurological disorders, alcoholism, or any other substance abuse

Subjects with a history of head trauma based on Survey

Subjects with MRI contra-indications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Empathy Training

Participants receive cognitive empathy training through a photo captioning intervention

6 months

Assessments at baseline, 10-day, and 6-month

Crossover

Participants crossover to the control condition or initiate the intervention

6 months

Assessments at 6-month and 10-day post-crossover

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

Assessment at 12-month completion

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Empathy Training

Trial Overview The study tests if cognitive empathy training can improve mental health, reduce inflammation, and boost immune function in dementia caregivers. It includes a control group for comparison and uses blood tests and MRIs to measure changes before and after the training.

How Is the Trial Designed?

Group I: Group 2: Control Condition Experimental Treatment 3 Interventions

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)

Group II: Group 1: Empathy Training Experimental Treatment 3 Interventions

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)

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The AREduX program uses augmented reality to simulate the physical and cognitive challenges faced by people living with dementia, aiming to enhance empathy among healthcare providers and caregivers.

This innovative training approach is designed to improve patient care and satisfaction by fostering empathetic responses, addressing a significant gap in existing empathy training programs for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented Reality Education Experience (AREduX): An Augmented Reality Experience and Experiential Education Medium to Teach Empathy to Healthcare Providers and Caregivers of Persons Living With Dementia. Hollaender, G., Peisachovich, E., Kapralos, B., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06650527

Effect of Cognitive Empathy Training on Dementia Caregivers Additionally, fostering cognitive empathy in caregivers may improve their mental health and the quality of care provided to individuals with dementia, ...

2. news.emory.edu news.emory.edu/stories/2024/10/er_aging_study_grant_dementia_caregivers_29-10-2024/story.html

Emory receives National Institute of Aging grant to study ... If successful, cognitive empathy training could be a cost-effective, scalable intervention to improve the quality of life for both caregivers ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5322939/

Effectiveness of person-centered care on people with ... Person-centered care interventions were shown to reduce agitation, neuropsychiatric symptoms, and depression and to improve the quality of life.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457224000375

Effects of empathy training on psychological concerns and ... Empathy training with a focus on cognitive empathy diminished psychological concerns in caregivers of older people and increased the levels of this ability ...

5. withpower.com withpower.com/trial/phase-caregivers-of-people-living-with-dementia-10-2024-6c652

Cognitive Empathy Training for Dementia Caregivers Trial Overview The study tests if cognitive empathy training can improve mental health, reduce inflammation, and boost immune function in dementia caregivers.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11918966/

Effectiveness of Virtual Reality on the Caregiving ... The subgroup analysis results showed significant improvement in caregiving competence in caregivers trained by the Dementia LiveTM program (effect size = 0.322 ...

7. link.springer.com link.springer.com/article/10.1007/s42979-025-04366-7

Immersive Simulation for Caregiver Empathy Training The rising prevalence of cognitive impairments in older adults necessitates novel caregiver training approaches.

8. digitalcommons.iwu.edu digitalcommons.iwu.edu/cgi/viewcontent.cgi?article=1016&context=all_honors

Evaluating Empathy and Understanding in Caregivers Increasing cognitive empathy can improve caregiver well-being, reduce distress, and foster more positive relationships with PWD. (Karana & Paun, ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S104161022401295X

Communication skills training in dementia care This review shows that communication skills training in dementia care significantly improves the quality of life and wellbeing of people with dementia.