Caregivers of People Living With DementiaNCT06650527
Effect of Cognitive Empathy Training on Dementia Caregivers
A study testing Cognitive Empathy Training, Pre and post intervention blood spot collection and Pre and post intervention MRI session in people with Caregivers of People Living With Dementia and Dementia, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers of People Living With Dementia, Dementia
- What is being tested?
- Cognitive Empathy Training, Pre and post intervention blood spot collection and Pre and post intervention MRI session
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Feb 2025to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Alter
Atlanta, Georgia, 30302
Fayron Epps, PhD,RN, 770-686-7730, outreach@alterdementia.com
- Recruiting
Emory Integrated Memory Care
Atlanta, Georgia, 30329
Carolyn Clevenger, PhD, 404-712-2394, carolyn.clevenger@emory.edu
- Recruiting
NIA Goizueta Alzheimer's Disease Research Center
Atlanta, Georgia, 30329
Allen Levey, MD, PhD, 404-727-6050
About this study
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
Read the 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.
- Being tested
- Cognitive Empathy Training, Control Condition, Pre and post intervention blood spot collection, Pre and post intervention MRI session
- Keywords
- Cognitive empathy, People Living With Dementia, Caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Empathy TrainingBehavioural
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 ConditionBehavioural
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 collectionProcedure or surgery
Also called Labs
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 sessionProcedure or surgery
Also called MRI scan
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Behavioral: Control Condition; Procedure: Pre and post intervention blood spot collection; Procedure: Pre and post intervention MRI session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, immediately post-training (10-Day), 6 months post-training
IL-6 levels
Cytokine (Measure of inflammation)
Measured: Baseline, immediately post-training (10-Day), 6 months post-training
IL-10 levels
Cytokine (Measure of inflammation)
Measured: Baseline, immediately post-training (10-Day), 6 months post-training
TNF-α levels
Cytokine (Measure of inflammation)
Measured: Baseline, immediately post-training (10-Day), 6 months post-training
Epstein-Barr virus antibody titers
Measure of immune system functioning
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, immediately post-training (10-Day), 6 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start13 Feb 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregivers of People Living With DementiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, James K. Rilling, Emory University
- Investigators
- James Rilling, PhD, Principal investigator, Emory College of Arts & SciencesKenneth Hepburn, PhD, Principal investigator, Emory School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650527
- Sponsor's protocol ID
- STUDY00007266
- Other IDs
- 1R01AG087216-01
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Empathy Training on Dementia Caregivers
- ClinicalTrials.gov ID
- NCT06650527
- Acronym / sponsor ID
- STUDY00007266
- Keywords
- Cognitive empathy, People Living With Dementia, Caregivers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1: Empathy Training | Experimental | Behavioral: Cognitive Empathy Training, Procedure: Pre and post intervention blood spot collection, Procedure: Pre and post intervention MRI sessionParticipants 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) |
| Group 2: Control Condition | Other | Behavioral: Control Condition, Procedure: Pre and post intervention blood spot collection, Procedure: Pre and post intervention MRI sessionDuring 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Empathy TrainingParticipants 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 | Behavioural | Group 1: Empathy Training |
| Control ConditionIn 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. | Behavioural | Group 2: Control Condition |
| Pre and post intervention blood spot collectionAlso: LabsAt 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. | Procedure or surgery | Group 1: Empathy Training, Group 2: Control Condition |
| Pre and post intervention MRI sessionAlso: MRI scanIn 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. | Procedure or surgery | Group 1: Empathy Training, Group 2: Control Condition |
Primary outcome
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.
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.
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.
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
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.
IL-6 levels
Time frame: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
IL-10 levels
Time frame: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
TNF-α levels
Time frame: Baseline, immediately post-training (10-Day), 6 months post-training
Cytokine (Measure of inflammation)
Epstein-Barr virus antibody titers
Time frame: Baseline, immediately post-training (10-Day), 6 months post-training
Measure of immune system functioning
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Rilling, PhD principal investigator
Emory College of Arts & Sciences
Kenneth Hepburn, PhD principal investigator
Emory School of Nursing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Empathy Training, Pre and post intervention blood spot collection and Pre and post intervention MRI session in people with Caregivers of People Living With Dementia and Dementia, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Rilling, PhD (404-727-3062, jrillin@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Burden Scale score (time frame: Baseline, immediately post-training (10-Day) , 6 months post-training). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.