Effect of Cognitive Empathy Training on Dementia Caregivers

BEHAVIORAL

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

BEHAVIORAL

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.

PROCEDURE

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.

PROCEDURE

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.

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.