Effect of Cognitive Empathy Training on Dementia Caregivers

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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 v
• Поведенческое 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.
• Процедура 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.
• Процедура 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 repeat

Первичные конечные точки

• Zarit Burden Scale score [Срок оценки: Baseline, immediately post-training (10-Day) , 6 months post-training]
• The Center for Epidemiological Studies Depression (CESD) Scale score [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• The State/Trait Anxiety Index (STAI) score [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• Perspective-taking subscale if the Interpersonal Reactivity Index (IRI) [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• Dyadic Relationship Scale score [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• IL-6 levels [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• IL-10 levels [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• TNF-α levels [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• Epstein-Barr virus antibody titers [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]
• fMRI activation within dorsomedial prefrontal cortex (DMPFC) for contrast (own person - unknown person) [Срок оценки: Baseline, immediately post-training (10-Day), 6 months post-training]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 3 центра

• Alter — Atlanta
• Emory Integrated Memory Care — Atlanta
• NIA Goizueta Alzheimer's Disease Research Center — Atlanta

Идентификаторы

NCT: NCT06650527 · STUDY00007266 · 1R01AG087216-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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