阿尔茨海默病患者家属压力的积极情绪调节干预的随机对照试验：LEAF 2.0 研究的方案和设计。

Randomized controlled trial of a positive emotion regulation intervention to reduce stress in family caregivers of individuals with Alzheimer's disease: protocol and design for the LEAF 2.0 study.

机构信息

Department of Medical Social Sciences, Northwestern University, Chicago, Illinois USA, USA.

Unversity of California, San Francisco, CA, USA.

出版信息

BMC Geriatr. 2024 Mar 27;24(1):289. doi: 10.1186/s12877-024-04817-5.

DOI:10.1186/s12877-024-04817-5

PMID:38539083

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10976670/

Abstract

BACKGROUND

Caring for a loved one with Alzheimer's disease can be stressful, resulting in poorer emotional and physical health among family caregivers. Although supportive resources for caregivers are available, distance, caregiver health, and the daily demands of caregiving are barriers to access. Based on research demonstrating the importance of positive emotions in coping with stress, our previous trial showed that dementia caregivers who participated in facilitated, web-based delivery of a positive emotion regulation intervention called LEAF (Life Enhancing Activities for Family caregivers) experienced increased positive emotion and decreased depression and anxiety. Building on this evidence, the LEAF 2.0 study aims to test whether web-based, self-guided delivery can confer similar benefits for caregivers of individuals with Alzheimer's disease.

METHODS

This paper presents the design and methods for LEAF 2.0, a 3-arm web-based randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's disease (AD) are randomized to (1) the LEAF intervention facilitated remotely via the web (N = 200), (2) the LEAF intervention self-guided online (N = 200), or (3) an emotion reporting control (N = 100), which then crosses over to the intervention after approximately 6 months, half to the facilitated arm and half to the self-guided arm. We aim to (1) compare the effect of the facilitated and self-guided LEAF positive emotion interventions to an emotion reporting control condition on AD caregiver well-being (positive emotion, depression, anxiety, and perceived stress) and secondary outcomes (caregiving burden, caregiving self-efficacy, positive aspects of caregiving, quality of care, and AD patient quality of life); (2) assess whether effects are mediated by improvements in positive emotion or other aspects of caregiver well-being; and (3) test whether caregiver age or gender or the care recipient's dementia severity moderates the effects of the intervention.

DISCUSSION

If demonstrated to be effective, LEAF can be widely disseminated and ultimately have a significant impact on the stress experienced by AD caregivers and the well-being of people living with Alzheimer's disease.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03610698.

摘要

背景

照顾患有阿尔茨海默病的亲人可能会带来压力，导致家庭照顾者的情绪和身体健康状况恶化。尽管有支持性资源供照顾者使用，但距离、照顾者的健康以及日常照顾需求都成为了获取资源的障碍。基于研究表明积极情绪在应对压力方面的重要性，我们之前的试验表明，参与了促进性、基于网络的积极情绪调节干预（称为 LEAF：家庭照顾者的生活增强活动）的痴呆症照顾者体验到了更多的积极情绪，同时抑郁和焦虑症状减轻。在此基础上，LEAF 2.0 研究旨在测试基于网络的自我指导交付是否可以为阿尔茨海默病患者的照顾者带来类似的益处。

方法

本文介绍了 LEAF 2.0 的设计和方法，这是一项 3 臂基于网络的随机对照试验（N=500），其中阿尔茨海默病（AD）患者的家庭照顾者被随机分为（1）通过网络远程促进的 LEAF 干预组（N=200），（2）在线自我指导的 LEAF 干预组（N=200），或（3）情绪报告对照组（N=100），大约 6 个月后交叉到干预组，一半进入促进组，一半进入自我指导组。我们的目标是：（1）比较促进和自我指导的 LEAF 积极情绪干预与情绪报告对照组在 AD 照顾者健康状况（积极情绪、抑郁、焦虑和感知压力）和次要结果（照顾负担、照顾自我效能、积极照顾方面、护理质量和 AD 患者生活质量）方面的效果；（2）评估效果是否通过积极情绪或照顾者健康状况的其他方面的改善来介导；（3）测试照顾者年龄或性别或受护理者痴呆症严重程度是否调节干预的效果。