Clinical trial NCT06650527: Effect of Cognitive Empathy Training on Dementia Caregivers
Official title: Effect of Cognitive Empathy Training on Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregivers of People Living With Dementia
Dementia
Keywords: Cognitive empathy
People Living With Dementia
Caregivers
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-21
Enrollment: 118
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Zarit Burden Scale score
timeFrame: Baseline, immediately post-training (10-Day) , 6 months post-training
measure: The Center for Epidemiological Studies Depression (CESD) Scale score
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: The State/Trait Anxiety Index (STAI) score
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: Perspective-taking subscale if the Interpersonal Reactivity Index (IRI)
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: Dyadic Relationship Scale score
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: IL-6 levels
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: IL-10 levels
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: TNF-α levels
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: Epstein-Barr virus antibody titers
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: fMRI activation within dorsomedial prefrontal cortex (DMPFC) for contrast (own person - unknown person)
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: fMRI activation within precuneus for contrast (own person - unknown person)
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: fMRI activation within temporo-parietal junction for contrast (own person - unknown person)
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
measure: fMRI activation within ventrolateral prefrontal cortex for contrast (own person - unknown person)
timeFrame: Baseline, immediately post-training (10-Day), 6 months post-training
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Alter
state: Georgia
city: Atlanta
country: United States
facility: Emory Integrated Memory Care
state: Georgia
city: Atlanta
country: United States
facility: NIA Goizueta Alzheimer's Disease Research Center
state: Georgia
Study officials:
affiliation: Emory College of Arts & Sciences
name: James Rilling, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory School of Nursing
name: Kenneth Hepburn, PhD
role: PRINCIPAL_INVESTIGATOR
References: