Stress Management Toolkit for Dementia

Overseen By Susan N Hastings, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Duke University

Disqualifiers: Hearing impairment, Visual impairment, Cytokine therapy, Radiation therapy, Cushing, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on creating and testing a stress management toolkit for people living with dementia and their care partners. The goal is to evaluate how well simple tools like weighted blankets, robotic pets, and aromatherapy help manage stress at home. After using these tools for two weeks, participants will provide feedback on their ease of use and effectiveness. This trial suits individuals with dementia who can communicate verbally and their caregivers, particularly if they live together outside of assisted living. As an Early Phase 1 trial, this research aims to understand how these innovative tools function in real-life settings, offering participants the opportunity to explore new stress management solutions.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are currently receiving cytokine-based therapy or radiation therapy to the salivary glands or thyroid, or if you have Cushing or Addison's disease.

What prior data suggests that this stress management toolkit is safe for people living with dementia and their care partners?

Research shows that the tools in the Stress Management Toolkit are very safe. These tools include weighted blankets, robotic pets, guided journals, aromatherapy, and bright light therapy devices. Previous studies have found that these tools are generally easy to use and pose minimal risk when used correctly.

The study's main concerns involve emotional reactions from discussing stress or the time commitment required. Improper use of the tools might cause slight physical discomfort, but each toolkit includes instructions. A research team member will review the safety information with participants to ensure correct usage. Overall, the study expects participants to face no more than minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stress Management Toolkit for dementia because it offers a personalized approach to managing stress for both patients and caregivers, unlike typical pharmaceutical treatments. This toolkit includes low-burden, high-safety tools like weighted blankets and robotic pets, which are designed to be user-friendly and non-invasive. Additionally, the toolkit's development involves direct feedback from dementia-caring pairs, ensuring that the tools are tailored to real-world needs and preferences. This approach could improve quality of life by addressing stress in a holistic and innovative way, potentially transforming dementia care.

What evidence suggests that this stress management toolkit is effective for dementia?

Studies have shown that certain tools can help manage stress for people with dementia and their caregivers. Weighted blankets, robotic pets, and aromatherapy calm and reduce anxiety. For example, weighted blankets feel like a gentle hug, which can be soothing. Robotic pets and baby dolls provide companionship and help with feelings of loneliness. Aromatherapy, using scents like lavender, may relax the mind. Early research suggests these tools improve mood and decrease stress when used regularly. This trial will combine these proven stress-relief methods into an easy-to-use Stress Management Toolkit, and participants will provide feedback on its usability and effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Susan N Hastings, MD

Principal Investigator

Duke University

Melissa L Harris, PhD

Principal Investigator

Duke University School of Nursing

Are You a Good Fit for This Trial?

This trial is for people aged 60 and over with any type of dementia who can speak English and express themselves verbally. It's also for their care partners. The study aims to help them manage stress at home using a toolkit.

Inclusion Criteria

Dyadic eligibility criteria: both the PLWD and care partner reside in the same household or personal residence in the community, dyad has lived together for at least 1 month, dyad has telephone or internet access

I am over 60, diagnosed with dementia, can speak for myself, and speak English.

Exclusion Criteria

My care partner has a hearing or visual impairment that affects their participation.

Dyads: reside in assisted living or other long-term care setting

I have dementia and a hearing or visual impairment that affects my participation in studies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prototype Development

Focus groups are conducted to explore experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress management and toolkit features.

4 weeks

4 focus groups (in-person)

User Testing

Ten dyads use the stress management toolkit at home for 2 weeks. Feedback on usability, feasibility, and acceptability is collected through questionnaires and focus groups.

2 weeks

3 focus groups (in-person) and questionnaires at end of weeks 1 and 2

Follow-up

Participants are monitored for stress-related outcomes and toolkit effectiveness after the user testing phase.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Stress Management Toolkit

Trial Overview The trial is testing a stress management toolkit designed specifically for those living with dementia and their caregivers. Participants will use tools like weighted blankets, robotic pets, journals, aromatherapy devices, etc., and provide feedback on the experience.

How Is the Trial Designed?

Group I: Stress Management Toolkit Prototype User Testing Experimental Treatment 1 Intervention

10 dyads will use the toolkit for 2 weeks in their own homes. Feedback on usability, feasibility, and acceptability will be collected through questionnaires and focus groups. Stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and salivary cortisol biospecimens will be collected at baseline and end of week 2, to explore their utility as endpoints in a future pilot study to examine efficacy.

Group II: Stress Management Toolkit Prototype Development Active Control 1 Intervention

3-4 qualitative focus groups (n=3-4 dyads/group) will be held to explore experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools (e.g., weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy, bright light therapy devices, massage and acupressure tools).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The Baycrest Quick-Response Caregiver ToolTM (BQRCT) was found to be highly feasible and helpful for 21 family caregivers managing neuropsychiatric symptoms of dementia, allowing them to effectively recognize and manage their emotions in real time.

Healthcare providers also found the tool useful, with most recommending it to others, highlighting its potential as a valuable online resource for caregivers who may struggle to access in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Instrument for Caregivers in Managing Neuropsychiatric Symptoms of Dementia: Baycrest Quick-Response Caregiver ToolTM. Madan, R., Natadiria, M., Berall, A., et al.[2022]

A randomized controlled trial involving 111 dyads of people with dementia and their caregivers tested a multi-component intervention but found no significant benefits on caregivers' mood, burden, or health outcomes over time.

The lack of effectiveness may be due to changes made in the intervention's design, such as its shortening and the exclusion of cognitive reframing, highlighting the importance of tailoring interventions to the specific needs and contexts of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a multi-component dyadic intervention on the psychological distress of family caregivers providing care to people with dementia: a randomized controlled trial. Prick, AE., de Lange, J., Twisk, J., et al.[2022]

The study aims to develop and test a user-friendly stress management toolkit for people living with dementia and their care partners, using simple, nonpharmacologic tools like animatronic pets and aromatherapy, to help manage stress effectively.

By employing a human-centered design approach and involving dementia caring dyads in the co-design process, the intervention is expected to be more acceptable and feasible for real-world use, with preliminary data supporting its potential for implementation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. Harris, M., Van Houtven, C., Hastings, S.[2022]

The program 'Learning to feel better… and help better' was successfully implemented in French-speaking Switzerland, showing high acceptance and strong participant engagement among informal caregivers of persons with dementia.

Participants experienced significant improvements in caregiver burden, psychological distress, and self-efficacy, indicating that the intervention effectively helps caregivers manage stress and apply learned coping strategies in their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with dementia caregiving: a mixed-methods study on feasibility and benefits of a psycho-educative group program. Pihet, S., Kipfer, S.[2019]

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]

The iCare Stress Management e-Training Program significantly reduced perceived stress among dementia family caregivers compared to an Education/Information-Only condition, indicating its potential efficacy in stress management.

Despite the positive results, the study faced a high dropout rate of about one-third of participants, highlighting the need for strategies to enhance engagement and retention in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. Kajiyama, B., Thompson, LW., Eto-Iwase, T., et al.[2022]

In a study of 213 caregivers, the most significant predictors of distress varied by caregiver type: for spouses, it was the impact on health and schedule, while for adult children living with the patient, it was primarily the impact on health.

Adult children not living with the person with dementia experienced distress related to health, schedule, and finances, highlighting the need for tailored support strategies for different caregiver profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of caregiver distress among spouses, adult children living with the person with dementia, and adult children not living with the person with dementia. Wawrziczny, E., Duprez, C., Antoine, P.[2021]

An educational intervention based on the Progressively Lowered Stress Threshold (PLST) model significantly improved the knowledge and caregiving practices of 38 caregivers for people with dementia over a two-year period in Isfahan, Iran.

The study demonstrated that tailored educational content, considering cultural and religious backgrounds, effectively enhanced caregivers' skills in managing challenging behaviors associated with dementia, as indicated by statistically significant increases in their knowledge and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of educational intervention based on the Progressively Lowered Stress Threshold extended model on the process of caregiving for people with dementia. Zamani-Alavijeh, F., Zahed, S., Emami, M., et al.[2023]

A music intervention for people with dementia and their family caregivers led to significantly lower morning cortisol levels in caregivers, indicating reduced stress levels after 8 weeks of the program.

The study involved 34 participants (24 in the intervention group and 10 in the control group) who provided saliva samples to measure stress biomarkers, demonstrating the potential of using such biomarkers to assess the effectiveness of interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing stress using repeated saliva concentration of steroid hormones in dementia care dyads: results from a controlled pilot care music intervention. Emami, A., Theorell, T., Kim, H., et al.[2023]

An 8-week mindfulness-based stress reduction (MBSR) training course significantly improved psychological resilience in non-professional caregivers of Alzheimer's patients, indicating its potential as an effective intervention for caregiver stress.

The study identified specific biomarkers in blood that predict which caregivers are likely to benefit from MBSR, providing insights into the mechanisms behind its health benefits and paving the way for personalized approaches in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. Ho, L., Bloom, PA., Vega, JG., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9798268/

Development of a Home-Based Stress Management ... This study will yield a working prototype of a stress management toolkit for dementia caring dyads, as well as preliminary data to support the feasibility and ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05465551

Study Details | NCT05465551 | Stress Management Toolkit ... We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and ...

3. trialx.com trialx.com/clinical-trials/listings/275185/stress-management-toolkit-for-people-living-with-dementia-and-their-care-partners/

Stress Management Toolkit for People Living With ... We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and ...

4. withpower.com withpower.com/trial/early-phase-1-caregiver-burden-7-2022-d34f8

Stress Management Toolkit for Dementia · Info for Participants The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia ...

5. aging.jmir.org aging.jmir.org/2025/1/e66017

Multimethods Pilot Study - JMIR Aging The outcome measures for people with dementia included self-care abilities, cognitive function, behavioral symptoms, and happiness levels.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05465551/stress-management-toolkit-for-people-living-with-dementia-and-their-care-partners

Stress Management Toolkit for People Living With Dementia and ... The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia ...

7. scholars.duke.edu scholars.duke.edu/publication/1556575

Development of a Home-Based Stress Management Toolkit ... RESULTS: This study will yield a working prototype of a stress management toolkit for dementia caring dyads, as well as preliminary data to support the ...