Effect of Cognitive Empathy Training on Dementia Caregivers

August 16, 2026 updated by: James K. Rilling, Emory University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30302
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Emory Integrated Memory Care
        • Contact:
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • NIA Goizueta Alzheimer's Disease Research Center
        • Contact:
          • Allen Levey, MD, PhD
          • Phone Number: 404-727-6050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Behavioral: Cognitive Empathy Training
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
Procedure: Pre and post intervention blood spot collection
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.
Other Names:
  • Labs
Procedure: Pre and post intervention MRI session
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.
Other Names:
  • MRI scan
Other: 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)
Procedure: Pre and post intervention blood spot collection
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.
Other Names:
  • Labs
Procedure: Pre and post intervention MRI session
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.
Other Names:
  • MRI scan
Behavioral: Control Condition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zarit Burden Scale score
Time Frame: 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.
Baseline, immediately post-training (10-Day) , 6 months post-training
IL-6 levels
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
Baseline, immediately post-training (10-Day), 6 months post-training
IL-10 levels
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
Baseline, immediately post-training (10-Day), 6 months post-training
TNF-α levels
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
Baseline, immediately post-training (10-Day), 6 months post-training
Epstein-Barr virus antibody titers
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of immune system functioning
Baseline, immediately post-training (10-Day), 6 months post-training
fMRI activation within precuneus for contrast (own person - unknown person)
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of activation within one cognitive empathy ROI
Baseline, immediately post-training (10-Day), 6 months post-training
fMRI activation within ventrolateral prefrontal cortex for contrast (own person - unknown person)
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of activation within an emotion regulation ROI
Baseline, immediately post-training (10-Day), 6 months post-training
Dyadic Relationship Scale score
Time Frame: 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.
Baseline, immediately post-training (10-Day), 6 months post-training
fMRI activation within dorsomedial prefrontal cortex (DMPFC) for contrast (own person - unknown person)
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
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)
Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of activation within one cognitive empathy (region of interest) ROI
Baseline, immediately post-training (10-Day), 6 months post-training
The Center for Epidemiological Studies Depression (CESD) Scale score
Time Frame: 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.
Baseline, immediately post-training (10-Day), 6 months post-training
The State/Trait Anxiety Index (STAI) score
Time Frame: 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.
Baseline, immediately post-training (10-Day), 6 months post-training
Perspective-taking subscale if the Interpersonal Reactivity Index (IRI)
Time Frame: 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
Baseline, immediately post-training (10-Day), 6 months post-training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: James Rilling, PhD, Emory College of Arts & Sciences
  • Principal Investigator: Kenneth Hepburn, PhD, Emory School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 16, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007266
  • 1R01AG087216-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available no later than the time of an associated publication or the end of the performance period, whichever comes first

IPD Sharing Access Criteria

Open Science Framework

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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