Effect of Cognitive Empathy Training on Dementia Caregivers

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06650527
Status
Recruiting
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Conditions

  • Caregivers of People Living With Dementia
  • Dementia

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

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
  • 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.
  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Feb 13, 2025
Status verified
Aug 2025
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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)

Primary Outcome Measure

Zarit Burden Scale score [ Time Frame: Baseline, immediately post-training (10-Day) , 6 months post-training ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
AlterAtlantaGeorgia30302
Fayron Epps, PhD,RN
[email protected]
770-686-7730
Emory Integrated Memory CareAtlantaGeorgia30329
Carolyn Clevenger, PhD
[email protected]
404-712-2394
NIA Goizueta Alzheimer's Disease Research CenterAtlantaGeorgia30329
Allen Levey, MD, PhD
404-727-6050

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By research site
Alter· Atlanta, GAEmory Integrated Memory Care· Atlanta, GANIA Goizueta Alzheimer's Disease Research Center· Atlanta, GA

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