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Active, Not Recruiting

NCT Number: NCT06708182

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Caregiving Stress Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Personal Satisfaction Psychological Well-Being Stress, Psychological Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Caregiver Burden measured using the Zarit Burden Interview.

    Time frame: Baseline and 8 weeks

    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.

  2. Positive Aspects of Caregiving measured using the Positive Aspects of Caregiving scale

    Time frame: Baseline and 8 weeks

    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.

  3. Positive Affect measured using the PROMIS Bank v1.0 Positive Affect

    Time frame: Baseline and 8 weeks

    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.

  4. Caregiver self-efficacy/mastery measured using the Caregiving Mastery subscale of the Caregiving Appraisal Measure

    Time frame: Baseline and 8 weeks

    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.

  5. Anxiety measured by PROMIS Bank v1.0 Anxiety

    Time frame: Baseline and 8 weeks

    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.

  6. Depression measured by PROMIS Bank v1.0 Depression

    Time frame: Baseline and 8 weeks

    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.

  7. Social isolation measured by PROMIS Bank v2.0 Social Isolation

    Time frame: Baseline and 8 weeks

    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.

  8. Self-efficacy measured by PROMIS Bank v1.0 General Self-Efficacy

    Time frame: Baseline and 8 weeks

    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.

  9. Life satisfaction measured by PROMIS Bank v1.0 General Life Satisfaction

    Time frame: Baseline and 8 weeks

    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.

  10. Perceived stress measured by Cohen's Perceived Stress Scale

    Time frame: Baseline and 8 weeks

    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.

  11. Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Baseline and 8 weeks

    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.

  12. Meaning and Purpose measured using PROMIS Bank v1.0 Meaning and Purpose

    Time frame: Baseline and 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • BrightOutcome
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: SAGE LEAF 2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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