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

Last updated: October 14, 2025
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

SAGE LEAF Positive Emotion Skills Course

Clinical Study ID

NCT06708182
STU00222543
2R44AG065080-03
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Identifies as primary family caregiver of someone with dementia

  • Speak and read English

  • Has access to high speed internet and wi-fi enabled device

Exclusion

Exclusion Criteria:

  • Care recipient lives in care facility

  • Does not speak/read English

  • Does not have access to internet

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: SAGE LEAF Positive Emotion Skills Course
Phase:
Study Start date:
July 02, 2025
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

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