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

NCT06708182 | Active Not Recruiting DMC

• 2 other identifiers: STU002225432R44AG065080-03
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caregiving Stress; Caregiver Burden

Keywords

Caregiving; Alzheimer's disease; Positive Emotion; Psychological well-being; Dementia

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

Study Arms (1)

Experimental: Positive emotion skills intervention

EXPERIMENTAL

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

Interventions

SAGE LEAF Positive Emotion Skills Course BEHAVIORAL

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.

Experimental: Positive emotion skills intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identifies as primary family caregiver of someone with dementia
• Speak and read English
• Has access to high speed internet and wi-fi enabled device

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Aging (NIA): collaborator
• BrightOutcome: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Alzheimer Disease; Psychological Well-Being; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction

Study Officials

• Judith Moskowitz, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair for Scientific and Faculty Development, Department of Medical Social Sciences

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)