Effect of Cognitive Empathy Training on Dementia Caregivers
NCT ID: NCT06650527
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
118 participants
INTERVENTIONAL
2025-02-13
2028-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
NCT05949047
Efficacy of VR Educational Program on Empathy and Attitudes Toward Dementia in Caregivers
NCT06072274
Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?
NCT05359679
Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)
NCT04603482
Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers
NCT04686266
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
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
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.
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)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
James K. Rilling
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Rilling, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory College of Arts & Sciences
Kenneth Hepburn, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory School of Nursing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alter
Atlanta, Georgia, United States
Emory Integrated Memory Care
Atlanta, Georgia, United States
NIA Goizueta Alzheimer's Disease Research Center
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Allen Levey, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00007266
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.