Effect of Cognitive Empathy Training on Dementia Caregivers

Emory University

Status: Enrolling

Conditions: Caregivers of People Living With Dementia; Dementia

Treatments: Behavioral: Control Condition; Behavioral: Cognitive Empathy Training; Procedure: Pre and post intervention blood spot collection; Procedure: Pre and post intervention MRI session

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06650527

1R01AG087216-01 (U.S. NIH Grant/Contract)

STUDY00007266

Details and patient eligibility

About

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

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

118 participants in 2 patient groups

Group 1: Empathy Training

Experimental group

Description:

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)

Treatment:

Procedure: Pre and post intervention MRI session

Procedure: Pre and post intervention blood spot collection

Behavioral: Cognitive Empathy Training

Group 2: Control Condition

Other group

Description:

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)

Treatment:

Procedure: Pre and post intervention MRI session

Procedure: Pre and post intervention blood spot collection

Behavioral: Control Condition