Stress Management Program for Caregivers of Dementia Patients

(MASC Trial)

Overseen By Arden O'Donnell, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropics

Disqualifiers: Mindfulness apps, Meditation, PMSQ >= 4, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers of individuals with Alzheimer's or similar conditions manage stress more effectively. It introduces the Mindful and Self-Compassionate Care Program (MASC), which teaches skills such as mindfulness (being present and aware), compassion, and managing challenging behaviors. Participants will engage in virtual group sessions and practice these skills at home. This trial may suit those who live with and care for someone with dementia, providing unpaid assistance for over six months, and who experience stress from their caregiving duties. As an unphased trial, it offers a unique opportunity to learn new skills that can enhance the caregiving experience.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have recently changed their treatment for depression or anxiety.

What prior data suggests that the MASC program is safe for caregivers of dementia patients?

In a previous study, mindfulness training helped caregivers of dementia patients become more aware of their emotions, making stress management easier. Another study showed that a mindfulness-based program could reduce caregiver burden and relieve stress. These findings suggest that mindfulness and self-compassion practices are generally well-tolerated. They can help caregivers manage stress without causing major issues. Similar programs have reported no serious side effects, indicating that the Mindful and Self-Compassionate Care Program (MASC) is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for stress management in caregivers of dementia patients, which often involves medication or traditional therapy, the MASC program focuses on integrating mindfulness and self-compassion into everyday life. Researchers are excited about this approach because it offers a non-pharmacological option that empowers caregivers with practical skills through virtual group sessions and at-home practice. This method not only aims to reduce stress but also enhances the overall well-being of caregivers by promoting behavioral management skills, making it a holistic alternative to existing treatments.

What evidence suggests that the MASC program is effective for managing stress in caregivers of dementia patients?

Research has shown that mindfulness and self-compassion programs can reduce stress in those caring for dementia patients. These programs teach skills that help caregivers become more aware of and accepting of their feelings, improving their ability to handle stress. Studies have found that incorporating behavior management skills into mindfulness and self-compassion training can further reduce caregiver stress. In this trial, participants will receive the MASC program, which combines these elements, teaching caregivers mindfulness, self-compassion, and behavior management. Early results suggest that this approach helps caregivers manage stress and handle difficult behaviors in dementia patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Christine Ritchie, MD, MSPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English and have been unpaid caregivers to someone with Alzheimer's or dementia for at least 6 months, providing an average of 4 hours of care daily. They must be experiencing stress from caregiving, live with the care recipient, and have dealt with challenging behaviors recently.

Inclusion Criteria

English fluency and literacy

Perceived Stress Scale-4 (4-item) version >=6

Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)

Exclusion Criteria

Involvement in another clinical trial for caregivers

A score >= 4 on the Portable Mental Status Questionnaire (PMSQ)

My medication for depression or anxiety was recently changed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in six virtual group sessions to learn mindfulness, self-compassion, and behavioral management skills, with at-home practice to integrate these skills into daily life.

6 weeks

6 virtual group sessions

Follow-up

Participants are monitored for stress, depression, anxiety, and well-being improvements post-intervention.

6-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MASC

Trial Overview The MASC program is being tested to see if it can reduce stress in caregivers. It includes mindfulness and self-compassion training, behavioral management skills, psychoeducation, and group practice sessions aimed at integrating these skills into their caregiving tasks.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention arm will be comprised of: 1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. 2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A pictorial tool called a fotonovela (FN) significantly reduced depressive symptoms in Latino dementia caregivers compared to standard informational materials, as shown in a study with 110 participants.

Caregivers using the FN found it more helpful and referred to it more often, highlighting its effectiveness in addressing the unique needs of Latino caregivers facing stress and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a fotonovela for reducing depression and stress in Latino dementia family caregivers. Gallagher-Thompson, D., Tzuang, M., Hinton, L., et al.[2022]

An eight-week mindfulness-based stress reduction (MBSR) program significantly reduced perceived stress and mood disturbance in family caregivers of individuals with Alzheimer's disease compared to a standard social support (SS) group, based on a pilot study with 38 participants.

While both MBSR and SS led to improvements in psychosocial outcomes at a three-month follow-up, there were no lasting differences in stress reduction or cortisol response between the two groups, suggesting that both interventions may contain effective elements for caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia. Brown, KW., Coogle, CL., Wegelin, J.[2022]

The Balance Study, involving 78 family caregivers of individuals with dementia, found that mindfulness-based stress reduction (MBSR) significantly improved mental health, reduced stress, and decreased depression compared to community caregiver education and support (CCES).

Both MBSR and CCES were effective in enhancing caregiver mental health, but MBSR showed superior benefits, suggesting it could be a valuable intervention for caregivers dealing with the chronic stress of caring for a family member with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Whitebird, RR., Kreitzer, M., Crain, AL., et al.[2022]

The mindfulness-based stress reduction program (MBSR) has been shown to effectively reduce anxiety, depression, and caregiver overload symptoms in family caregivers of people with dementia, based on a review of 5 randomized trials involving 309 participants.

While MBSR demonstrated positive effects immediately after the program, some studies indicated that these benefits may diminish over time, highlighting the need for further research to establish consistent protocols and long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of a mindfulness-based stress reduction program for family caregivers of people with dementia. Systematic review of randomised clinical trials]. Grandi, F., Burgueño, L., Irurtia, MJ.[2020]

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 integrative stress reduction program (ISRP) significantly decreased caregiver stress and improved sleep quality, as measured by the Relative Stress Scale and Pittsburgh Sleep Quality Index, in a study involving 12 family caregivers over 4 weeks.

Care recipients also showed a reduction in behavioral and psychological symptoms of dementia (BPSD), indicating that the ISRP not only benefits caregivers but also positively impacts the well-being of those they care for.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. Sanprakhon, P., Chaimongkol, N., Hengudomsub, P., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39928550/

Development of a Mindfulness and Self-compassion (MASC ... A new program that integrates emotional regulation skills (mindfulness, compassion, and self-compassion), with practical strategies to manage behavioral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11512127/

Protocol for the Mindful and Self-Compassion Care ... The first program that combines mindfulness and self-compassion with behavioral management skills to decrease caregiver stress.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04977245

Mindfulness-Based Stress Reduction in Dementia Caregivers Mindfulness training can help caregivers of dementia patients to be more aware of their emotional states, by enabling them to better acknowledge and accept any ...

4. aging.jmir.org aging.jmir.org/2021/4/e28652/

An App-Based Mindfulness-Based Self-compassion Program ... Evaluation of the short-term efficacy of this intervention to support primary caregivers of persons with dementia yielded mixed results.

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.70064

A mindfulness‐based multicomponent caregiver intervention ... Caregivers in PAACC reported higher depressive symptoms and anxiety and lower mindfulness receptivity. This study introduces the first ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6491691/

Mindfulness-Based Intervention for People With Dementia ... Quantitative data showed a small effect for an increase in quality of life in caregivers and a decrease for PwD. Participants did not show a ...