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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Caregiver Burden; Caregiving Stress
• Intervention / Treatment: Behavioral: SAGE LEAF Positive Emotion Skills Course

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Criteria:

• Care recipient lives in care facility
• Does not speak/read English
• Does not have access to internet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: Positive emotion skills intervention; Participants will go through a 6-week positive emotion skills course where 1 new skill lesson opens each week.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Burden measured using the Zarit Burden Interview.	Assesses perceived burden in caregivers by assessing subjective feelings of the impact of caregiving on emotional and physical health, financial strain, and social functioning. Scale values range from "Never" to "Nearly Always" with higher scores reflect greater burden.	Baseline and 8 weeks
Positive Aspects of Caregiving measured using the Positive Aspects of Caregiving scale	11-item scale that identifies positive consequences of caregiving, such as feeling more useful, feeling appreciated, and strengthening relationships with others. Values range from "Disagree a lot" to "Agree a lot." Higher scores indicate greater identification of the positives of being a caregiver.	Baseline and 8 weeks
Positive Affect measured using the PROMIS Bank v1.0 Positive Affect	Computer adaptive test (CAT) that assess momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, elation, contentment, pride, affection, happiness, engagement, and excitement, over the past 7 days, using a scale of not at all to very much, where higher scores indicate higher levels of positive emotion.	Baseline and 8 weeks
Caregiver self-efficacy/mastery measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure	12-item Caregiving Mastery subscale of the Caregiving Appraisal Measure. Values range from "Disagree a lot" to "Agree a lot" and "Never" to "Nearly Always" with higher scores indicating higher feelings of caregiving mastery.	Baseline and 8 weeks
Anxiety measured by PROMIS Bank v1.0 Anxiety	Computer adaptive test (CAT) that assesses level of anxiety by having participants rate items focused on depressive symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of anxiety.	Baseline and 8 weeks
Depression measured by PROMIS Bank v1.0 Depression	Computer adaptive test (CAT) that assesses depressive mood by having participants rate items focused on depressive symptoms over the past 7 days, using scale from Never to Always, where higher scores indicate higher levels of depression.	Baseline and 8 weeks
Perceived stress measured by Cohen's Perceived Stress Scale	Ten item scale that measure the degree to which situations in one's life are appraised as stressful. Respondents are asked to indicate how often they felt or thought a certain way during the last month on a scale of 0 (Never) to 4 (Very Often), with higher scores indicating higher levels of perceived stress.	Baseline and 8 weeks
Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)	12-item measure of perceived adequacy of social support from three sources: family, friends, & significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree), where higher scores indicate higher perceptions of social support.	Baseline and 8 weeks
Meaning and Purpose measured using PROMIS Bank v1.0 Meaning and Purpose	Computer adaptive test (CAT) assesses the degree to which one feels life has purpose and there are good reasons for living, including hopefulness, optimism, goal-directedness, and feelings that one's life is worthy. Scale values range from "Strongly disagree" to "Strongly agree" on items 1-3, and "Not at all" to "Very much" on items 4-8, with higher values associated with a higher sense of meaning and purpose.	Baseline and 8 weeks
Social isolation measured by PROMIS Bank v2.0 Social Isolation	Computer adaptive test (CAT) that assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Values range from Never to Always, and higher scores indicate higher degree of social isolation.	Baseline and 8 weeks
Self-efficacy measured by PROMIS Bank v1.0 General Self-Efficacy	Computer adaptive test (CAT) that assesses ones confidence in their ability to succeed in specific situations or complete a task. Values range from "I am not at all confident" to "I am very confident", where higher scores indicate higher confidence.	Baseline and 8 weeks
Life satisfaction measured by PROMIS Bank v1.0 General Life Satisfaction	Computer adaptive test (CAT) assesses one's cognitive evaluation of life experiences and whether one likes his/her life or not. Values range from "Strongly disagree" to "Strongly agree" with higher scores indicating higher degrees of satisfaction with one's life.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute on Aging (NIA); BrightOutcome
• Investigators: Principal Investigator: Judith Moskowitz, PhD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Dementia; Caregiving; Psychological well-being; Positive Emotion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavior; Personal Satisfaction; Caregiver Burden; Alzheimer Disease; Dementia; Psychological Well-Being
• Other Study ID Numbers: STU00222543; 2R44AG065080-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No