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NCT Number: NCT06650527

Effect of Cognitive Empathy Training on Dementia Caregivers

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

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Key information

Conditions

Caregivers of People Living With Dementia Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alter, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Labs

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.

Other names: MRI scan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. IL-6 levels

    Time frame: Baseline, immediately post-training (10-Day), 6 months post-training

    Cytokine (Measure of inflammation)

  7. IL-10 levels

    Time frame: Baseline, immediately post-training (10-Day), 6 months post-training

    Cytokine (Measure of inflammation)

  8. TNF-α levels

    Time frame: Baseline, immediately post-training (10-Day), 6 months post-training

    Cytokine (Measure of inflammation)

  9. Epstein-Barr virus antibody titers

    Time frame: Baseline, immediately post-training (10-Day), 6 months post-training

    Measure of immune system functioning

  10. 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

  11. 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

  12. 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

  13. 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

Study contacts

Contact information is provided by the study sponsor or research team.

James Rilling, PhD

CONTACT

[email protected]

404-727-3062

Kenneth Hepburn, PhD

CONTACT

[email protected]

404-712-9286

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2024
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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