Caregiving StressSAGE LEAF 2NCT06708182
SAGE LEAF 2: An Online Program to Reduce Dementia Caregiver Burden
A study testing SAGE LEAF Positive Emotion Skills Course in people with Caregiving Stress and Caregiver Burden, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiving Stress, Caregiver Burden
- What is being tested?
- SAGE LEAF Positive Emotion Skills Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identifies as primary family caregiver of someone with dementia
- Speak and read English
- Has access to high speed internet and wi-fi enabled device
Who cannot join
- Care recipient lives in care facility
- Does not speak/read English
- Does not have access to internet
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- SAGE LEAF Positive Emotion Skills Course
- Keywords
- Caregiving, Alzheimer's disease, Positive Emotion, Psychological well-being, Dementia
- Medical subject headings
- Caregiver Burden, Alzheimer Disease, Psychological Well-Being, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGE LEAF Positive Emotion Skills CourseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SAGE LEAF Positive Emotion Skills Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start2 Jul 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiving StressStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), BrightOutcome
- Responsible party
- Principal investigator, Judith Moskowitz, Northwestern University
- Investigators
- Judith Moskowitz, PhD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708182
- Sponsor's protocol ID
- STU00222543
- Other IDs
- 2R44AG065080-03
- Acronym
- SAGE LEAF 2
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06708182
- Acronym / sponsor ID
- SAGE LEAF 2 / STU00222543
- Conditions
- Caregiving Stress, Caregiver Burden
- Keywords
- Caregiving, Alzheimer's disease, Positive Emotion, Psychological well-being, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), BrightOutcome
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Positive emotion skills intervention | Experimental | Behavioral: SAGE LEAF Positive Emotion Skills CourseParticipants will go through a 6-week positive emotion skills course where 1 new skill lesson opens each week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Identifies as primary family caregiver of someone with dementia
- Speak and read English
- Has access to high speed internet and wi-fi enabled device
Key exclusion criteria (3 listed)
- Care recipient lives in care facility
- Does not speak/read English
- Does not have access to internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGE LEAF Positive Emotion Skills CourseThe 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. | Behavioural | Experimental: Positive emotion skills intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Related trials for Caregiving Stress
Recruiting
Leveraging Interventions for Caregiver Growth, Health, Training, Empowerment and Navigation: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain
Elevated Caregiver Strain, Dementia Caregiver
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.
Breast Cancer, Lung Cancer
Active, not recruiting
Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
Head and Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Moskowitz, PhD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAGE LEAF Positive Emotion Skills Course in people with Caregiving Stress and Caregiver Burden, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden measured using the Zarit Burden Interview. (time frame: Baseline and 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.