Online Program for Dementia Caregiver Burden

(SAGE LEAF 2 Trial)

Overseen By Caroline Leong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Care recipient in facility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program to determine if it can help family caregivers of people with dementia manage stress more effectively. It focuses on teaching positive emotion skills to see if these can reduce feelings of loneliness and depression and lessen the burden of caregiving. Participants will complete an 8-week online course, the SAGE LEAF Positive Emotion Skills Course, and take surveys before and after to assess changes. It suits those who are primary caregivers of someone with dementia, can speak and read English, and have internet access. As an unphased trial, this study offers caregivers a unique opportunity to explore innovative strategies for stress management and emotional well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SAGE LEAF program is safe for caregivers?

Research has shown that the SAGE LEAF online program has been tested for its effects on caregivers of people with dementia. In earlier studies, caregivers who participated in similar online programs focusing on positive emotions reported improved emotional well-being. These programs teach skills to enhance positive feelings and manage stress.

No negative side effects or major safety issues have been reported with the SAGE LEAF program. The program's main goal is to teach skills for better stress management, indicating it is generally well-tolerated. As an online course aimed at improving emotional skills, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAGE LEAF Positive Emotion Skills Course because it offers a fresh approach to alleviating caregiver burden for dementia. Unlike traditional options that might focus on direct medical interventions or support groups, this program empowers caregivers through emotional skills training over six weeks. By enhancing positive emotions, it aims to provide caregivers with tools to better cope with stress, potentially improving both their well-being and the care they give. This psychological approach is unique as it directly targets the emotional resilience of caregivers, rather than just addressing the physical aspects of caregiving.

What evidence suggests that the SAGE LEAF program is effective for reducing caregiver burden in dementia?

Studies have shown that the SAGE LEAF online program, which participants in this trial will undergo, can help reduce the stress of caring for someone with dementia and boost positive feelings. Research indicates that participants often feel less lonely and less depressed after completing the program. Specifically, one study found that caregivers using this online course experienced small to medium improvements in managing their emotions. These findings suggest that learning and using positive emotion skills through SAGE LEAF can significantly improve the well-being of those caring for people with dementia. ^{1 2 3 6 7}

Who Is on the Research Team?

Judith Moskowitz, Ph.D.

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for family caregivers of individuals with dementia. Participants should be experiencing stress related to their caregiving responsibilities and must have access to the internet to complete an 8-week online program. The study aims to help them cope better.

Inclusion Criteria

* Identifies as primary family caregiver of someone with Alzheimer's disease

* Speak and read English

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete the 8-week online SAGE LEAF intervention, involving weekly self-guided positive emotion skill lessons, daily skill practice exercises, and daily emotion reporting.

8 weeks

Follow-up

Participants are monitored for changes in positive emotion, caregiver burden, loneliness, and depression after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAGE LEAF Positive Emotion Skills Course

Trial Overview The SAGE LEAF online course is being tested for its effectiveness in reducing caregiver burden and improving positive emotions, loneliness, and depression among dementia caregivers through a self-guided program delivered by Caregiver Serving Organizations.

How Is the Trial Designed?

Group I: Experimental: Positive emotion skills intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

BrightOutcome, Inc.

Collaborator

Trials

4

Recruited

240+

BrightOutcome

Industry Sponsor

Trials

7

Recruited

610+

Published Research Related to This Trial

A systematic review of 19 studies found that online dementia training programs significantly improve the preparedness and condition of both formal and informal caregivers, addressing the growing need for skilled dementia care as Alzheimer's disease rates rise.

Future research should focus on enhancing study designs by incorporating multiple time points, control groups, and personalized, interactive content to better evaluate the effectiveness of these online training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online dementia caregivers training programs: A systematic review. Pleasant, M., Molinari, V., Dobbs, D., et al.[2021]

The dementia Carer Education Programme increased carers' knowledge about dementia but did not significantly improve their quality of life, burden, or well-being after six months, based on a study of 32 carers.

Carers who reported a worsening situation post-programme experienced poorer quality of life and increased burden, highlighting that patient behavior disturbance was a key factor affecting their experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dementia carer education and patient behaviour disturbance. Coen, RF., O'Boyle, CA., Coakley, D., et al.[2006]

A systematic review of 24 studies on dyadic psychoeducational support programs for people with dementia and their caregivers found that tailored, goal-oriented programs significantly improve various aspects of health and quality of life for both parties.

The review highlights the importance of long-term, individualized support programs to address the progressive needs of individuals with dementia and their caregivers, suggesting that such interventions can lead to sustained positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of dyadic psychoeducational programs for persons with dementia and their family caregivers. Ghosh, M., Dunham, M., O'Connell, B.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06708182?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22BrightOutcome%22)&viewType=Table&rank=3

SAGE LEAF 2: An Online Program to Reduce Dementia ... Individual level effectiveness will be assessed using self-reported outcomes, such as positive affect, caregiver burden, loneliness, and depression. These ...

2. withpower.com withpower.com/trial/online-program-for-dementia-caregiver-burden-e5cb0

Online Program for Dementia Caregiver Burden Trial Overview The SAGE LEAF online course is being tested for its effectiveness in reducing caregiver burden and improving positive emotions, loneliness, and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05562583

SAGE-LEAF: Reducing Burden in Alzheimer's Disease ... The goal of the proposed study, is to adapt a positive emotion intervention for Alzheimer's Disease (AD) caregivers into a self-guided online format that ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6501812/

Randomized Controlled Trial of a Facilitated Online Positive ... This randomized controlled trial of the online facilitated positive emotion regulation intervention in dementia caregivers demonstrated small to medium effect ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06708182/sage-leaf-2-an-online-program-to-reduce-dementia-caregiver-burden

SAGE LEAF 2: An Online Program to Reduce Dementia ... The main questions it aims to answer are: How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family ...

6. ctv.veeva.com ctv.veeva.com/study/sage-leaf-2-an-online-program-to-reduce-dementia-caregiver-burden

An Online Program to Reduce Dementia Caregiver Burden The SAGE LEAF intervention is 8 weeks long and involves weekly self-guided positive emotion skill lessons, daily skill practice exercises, and daily emotion ...

7. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-04817-5

Randomized controlled trial of a positive emotion regulation ... The LEAF 2.0 study aims to test whether web-based, self-guided delivery can confer similar benefits for caregivers of individuals with Alzheimer's disease.