Effect of Cognitive Empathy Training on Dementia Caregivers

NCT06650527 | Recruiting

• 2 other identifiers: STUDY000072661R01AG087216-01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

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

Keywords

Cognitive empathy; People Living With Dementia; Caregivers

Outcome Measures

Primary Outcomes (13)

• 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

  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

Study Arms (2)

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)

Behavioral: Cognitive Empathy Training; Procedure: Pre and post intervention blood spot collection; Procedure: Pre and post intervention MRI session

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)

Behavioral: Control Condition; Procedure: Pre and post intervention blood spot collection; Procedure: Pre and post intervention MRI session

Interventions

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

Group 1: Empathy Training

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.

Group 2: Control Condition

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.

Also known as: Labs

Group 1: Empathy Training; Group 2: Control Condition

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.

Also known as: MRI scan

Group 1: Empathy Training; Group 2: Control Condition

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Alter

Atlanta, Georgia, 30302, United States

RECRUITING

Emory Integrated Memory Care

Atlanta, Georgia, 30329, United States

RECRUITING

NIA Goizueta Alzheimer's Disease Research Center

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

Lead; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• James Rilling, PhD

  Emory College of Arts & Sciences

  PRINCIPAL INVESTIGATOR

• Kenneth Hepburn, PhD

  Emory School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Rilling, PhD

CONTACT

404-727-3062; jrillin@emory.edu

Kenneth Hepburn, PhD

CONTACT

404-712-9286; khepbur@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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
• Access Criteria: Open Science Framework

Locations

US (3)