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

Not Applicable

Completed

Conditions: Alzheimer Disease

Interventions: Behavioral: SAGE LEAF

Registration Number: NCT05562583

Lead Sponsor: BrightOutcome

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

Inclusion Criteria

Adults age 18 and over who identify as the primary caregiver of a family member with Alzheimer's Disease
Co-reside with the family caregiver
Speak and read English
Have internet access and a reliable email address

Exclusion Criteria

None

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention (single arm)	SAGE LEAF	5 session self-guided online delivered positive emotion regulation intervention with social components.

Primary Outcome Measures

Name	Time	Method
Percentage of Skill Pages in SAGE-LEAF Accessed by a Participant	Post-study (week 6)	This is to measure adherence to SAGE-LEAF intervention. Score range: 0-100%. A higher percentage means better adherence to the SAGE-LEAF intervention.
Willingness to Recommend SAGE-LEAF to Other AD Caregivers	Post-study (week 6)	This is to measure the acceptability of SAGE-LEAF. Score range: 1-10. A higher score indicates higher acceptability.
System Usability Scale	Post-study (week 6)	This is to measure the usability of SAGE-LEAF. Score range: 0-100. A higher score indicates better usability.

Secondary Outcome Measures

Name	Time	Method
Zarit Burden Interview	Pre-study and post-study (week 6)	Measuring caregiving burden. Score range: 0-88. Higher scores indicate greater burden.
Oberst Caregiving Burden Scale - Time	Pre-study and post-study (week 6)	Measuring caregiving burden in terms of time. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Caregiving Mastery Subscale of the Caregiving Appraisal Measure	Pre-study and post-study (week 6)	Measuring caregiving mastery. Score range: 1-5. Higher scores indicate better caregiving mastery.
Role Captivity Sub-scale of Caregiver Reaction Assessment	Pre-study and post-study (week 6)	Measuring role captivity in caregiving. Score 1-4. Higher scores indicate stronger feelings of role captivity.
Overload Sub-scale of Caregiver Reaction Assessment	Pre-study and post-study (week 6)	Measuring the feeling of overload in caregiving. Score 1-4. Higher scores indicate stronger feelings of overload.
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance	Pre-study and post-study (week 6)	Measuring sleep disturbance level. Score range: 20-80. Higher scores indicate higher levels of sleep disturbance.
Oberst Caregiving Burden Scale - Difficulty	Pre-study and post-study (week 6)	Measuring caregiving burden in terms of difficulty. Score range: 1-5. Higher scores indicate higher levels of caregiver burden.
Positive Aspects of Caregiving Scale	Pre-study and post-study (week 6)	Measuring positive aspects to caregiving for dementia patients. Score range: 5-45. Higher scores indicate better caregivers' outlook on life and self-affirmations.
Cohen's Perceived Stress Scale	Pre-study and post-study (week 6)	Measuring perceived stress. Score range: 0-40. Higher scores indicate higher levels of perceived stress
Patient-Reported Outcomes Measurement Information System - Depression	Pre-study and post-study (week 6)	Measuring depression level. Score range: 20-80. Higher scores indicate higher depression levels.
Patient-Reported Outcomes Measurement Information System - Anxiety	Pre-study and post-study (week 6)	Measuring anxiety level. Score range: 20-80. Higher scores indicate higher anxiety levels.
Patient-Reported Outcomes Measurement Information System - Meaning and Purpose	Pre-study and post-study (week 6)	Measuring one's sense of life having purpose and that there are good reasons for living. Score range: 20-80. Higher scores indicate hopefulness, optimism, goal-directedness, and feelings that one's life is worthy.
Patient-Reported Outcomes Measurement Information System - Social Isolation	Pre-study and post-study (week 6)	Measuring perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Score range: 20-80. Higher scores indicate higher levels of perception of social isolation.
Positive Affect in Differential Emotions Scale	Pre-study and post-study (week 6)	Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of positive emotions.
Negative Affect in Differential Emotions Scale	Pre-study and post-study (week 6)	Measuring positive emotions. Score range: 1-5. Higher scores indicate higher levels of negative emotions.