Recruiting

Cognitive Empathy Training

Sponsor:

Emory University

Code:

NCT06650527

Conditions

Caregivers of People Living With Dementia

Dementia

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Cognitive Empathy Training

Control Condition

Pre and post intervention blood spot collection

Pre and post intervention MRI session

Study Details

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

Conditions

Caregivers of People Living With Dementia

Dementia

Study ID

NCT06650527

Start date

Feb 13, 2025

Status verified date

Aug, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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)

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)

Interventions

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

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.

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.

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.

Primary outcome measure

  • Zarit Burden Scale score [ Time Frame: 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 State/Trait Anxiety Index (STAI) score [ Time Frame: 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 ]
  • Dyadic Relationship Scale score [ Time Frame: 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 ]
  • IL-10 levels [ Time Frame: 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 ]
  • Epstein-Barr virus antibody titers [ Time Frame: 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 ]
  • fMRI activation within precuneus for contrast (own person - unknown person) [ Time Frame: 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 ]
  • fMRI activation within ventrolateral prefrontal cortex for contrast (own person - unknown person) [ Time Frame: Baseline, immediately post-training (10-Day), 6 months post-training ]

Central Contacts and Locations

Central contacts

James Rilling, PhD

404-727-3062jrillin@emory.edu

Kenneth Hepburn, PhD

404-712-9286khepbur@emory.edu

Locations

Alter

Recruiting

Atlanta, Georgia, United States, 30302

Contacts

Fayron Epps, PhD,RN

770-686-7730outreach@alterdementia.com

Emory Integrated Memory Care

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Carolyn Clevenger, PhD

404-712-2394carolyn.clevenger@emory.edu

NIA Goizueta Alzheimer's Disease Research Center

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Allen Levey, MD, PhD

404-727-6050

More Information

Sponsor

Emory University

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Cognitive empathy
  • People Living With Dementia
  • Caregivers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.