SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support — SAGE-LEAF  

Alzheimer Disease Clinical Trial

Official title: SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support

Status Completed

Clinical Trial Summary

The goal of the proposed study, is to adapt a positive emotion intervention for Alzheimer's Disease (AD) caregivers into a self-guided online format that incorporates social connection components and adaptive system feedback mechanisms to promote intervention adherence. Previous tests of the facilitated version of the program, called SAGE-LEAF (Social Augmentation to self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), have shown efficacy for improving well-being in dementia caregivers. If effective, the SAGE-LEAF program can be disseminated to Alzheimer's caregivers nationwide through AD treatment and research centers.

Clinical Trial Description

The prevalence of Alzheimer's Disease (AD) and other dementias is steadily climbing and predicted to affect as many as 16 million Americans by 2050. In 2016, 59% of dementia caregivers reported experiencing high levels of emotional and physical stress, and the risk that the chronic stress of dementia caregiving places on caregivers for developing a range of physical and mental health issues is extensively documented. Caregiving-related stress contributes to social isolation, loneliness, and physical illness and increases the risk of caregiver death. Interventions for dementia caregivers have primarily focused on reducing negative emotions and burden. However, over the past few decades, it has become clear that positive emotions are uniquely related to better psychological and physical well-being, independent of the effects of negative emotion suggesting that an intervention that specifically targets positive emotion holds promise for improving caregiver well-being and, ultimately, quality of care for the individual living with AD. The investigators' recent randomized trial of the positive emotion skills intervention, delivered by trained facilitators via the web in N = 170 family caregivers of people with dementia resulted in significant improvements in caregiver psychological well being. However, facilitator-delivered interventions are costly and difficult to implement with fidelity on a large scale. Furthermore, a major challenge to advancing behavioral interventions delivered by trained facilitators is assuring fidelity. The investigators have developed a self-guided online version of the intervention that has shown feasibility and acceptability in several samples, but this version does not capture the critical social connection aspects of the facilitator-delivered intervention. The investigators propose to take the next step toward closing the science-to-practice gap for the positive emotion regulation intervention by tailoring the self-guided online version specifically for dementia caregivers that incorporates the social connection components to combat the loneliness and isolation experienced by many Alzheimer's caregivers. The intervention, called SAGE-LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), leverages the lessons learned from the original LEAF project and adapts its positive emotion intervention to AD caregivers in a self-guided format while incorporating social connection components and adaptive system feedback mechanisms to promote intervention adherence. ;

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT05562583
• Study type: Interventional
• Source: BrightOutcome
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Completion date: April 30, 2022