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

13 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment MASC for caregivers of dementia patients?

Research shows that stress reduction programs, like the integrative stress reduction program (ISRP) and mindfulness-based stress reduction (MBSR), can significantly decrease stress and improve sleep quality for caregivers of dementia patients. These programs have also been shown to reduce behavioral and psychological symptoms in dementia patients, suggesting that similar treatments like MASC may also be effective. ^{1 2 3 4 5}

Is the Stress Management Program for Caregivers of Dementia Patients safe for humans?

The stress management programs mentioned, which include non-drug tools like animatronic pets and aromatherapy, are described as simple and safe for use at home. These interventions have been shown to reduce stress and improve sleep quality in caregivers, suggesting they are generally safe for humans. ^{1 2 6 7 8}

How is the MASC treatment different from other treatments for caregivers of dementia patients?

The MASC treatment is unique because it focuses on stress management specifically for caregivers of dementia patients, potentially incorporating elements like mindfulness and educational sessions, which are not typically part of standard medical treatments for dementia caregiving stress. ^{1 2 4 9 10}

What is the purpose of this trial?

Building on limitations of prior research, the investigators proposed to develop the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.

Research Team

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Christine Ritchie, MD, MSPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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)

No stated concerns or distress related to care recipient's disruptive behaviors

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The Going to Stay at Home program: combining dementia caregiver training and residential respite care. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a fotonovela for reducing depression and stress in Latino dementia family caregivers. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia. [2022]

6. Canada 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Stress in Persons with Dementia: Benefits of a Memory Center Day Program. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Opening Minds through Art: A preliminary study evaluating the effects of a creative-expression program on persons living with dementia and their primary care partners. [2021]

9. Spain 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]. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Supporting Caregivers of Veterans with Dementia. [2023]