NCT06708182

SAGE LEAF 2: An Online Program to Reduce Dementia Caregiver Burden

Social Augmentation of Self-Guided Electronic Delivery of the Life Enhancing Activities for Family Caregivers (SAGE LEAF 2): An Online Self-Guided Positive Emotion Regulation Program to Reduce Alzheimer's Dementia Caregiver Burden Delivered Through Caregiver-Serving Organizations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers) online positive emotion skill-building program delivered through Caregiver Serving Organizations can help family caregivers of individuals with dementia cope with stress. The main questions it aims to answer are: * How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family caregivers? * What are the challenges and successes when rolling out an online program in partnership with Caregiver Serving Organizations? Participants will complete the 8-week online SAGE LEAF intervention as well as two survey assessments, one before the intervention and one after.

Detailed description

The SAGE LEAF 2 study is a single-arm fully online implementation trial of the SAGE LEAF program delivered to family caregivers through Caregiver Serving Organizations (CSOs). The SAGE LEAF intervention is 8 weeks long and involves weekly self-guided positive emotion skill lessons, daily skill practice exercises, and daily emotion reporting, all housed on the SAGE LEAF website. The website also includes social features, such as a discussion board and profile pages, to facilitate social connection among participants. Up to n=140 family caregivers of individuals with dementia will be recruited through CSOs and the general population. To participate, caregivers must (1) identify as the primary family caregiver of a person with dementia, (2) be at least 18 years old, (3) speak and read English, and (4) have access to high-speed internet. Participants will complete survey assessments via REDCap before and after they go through the SAGE LEAF intervention. All study activities will take place online. Individual level effectiveness will be assessed using self-reported outcomes, such as positive affect, caregiver burden, loneliness, and depression. These outcomes will be measured both pre- and post-intervention. Implementation barriers and facilitators will be assessed using follow-up qualitative interviews.

Conditions

• Caregiving Stress
• Caregiver Burden

Interventions

Type	Name	Description
BEHAVIORAL	SAGE LEAF Positive Emotion Skills Course	The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access. A week will consist of 1-2 days of didactic material and 5-6 days of real-life skills practice and reporting. Participants cannot skip ahead, and can only progress to the next lesson if they have completed the current one, but they can return to old lessons or exercises if they wish to. Skills include: positive events, capitalizing, gratitude, mindfulness, positive reappraisal, personal strengths, achievable goals, self-compassion.

Timeline

• Start date: 2025-07-02
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-11-27
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States