Mindfulness Program for Caregiver Stress

(SOCIAL Trial)

Overseen By Maggie Crean, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Depression, Anxiety

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: 6-8 weeks

82 Participants Needed

Trial Summary

Do I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you've had a recent change in prescribed medications for depression or anxiety within the past 6 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've recently changed medications for depression or anxiety in the past 6 weeks.

What data supports the idea that Mindfulness Program for Caregiver Stress is an effective treatment?

The available research shows that the Mindfulness Program for Caregiver Stress can be effective in reducing stress and improving resilience among caregivers. For example, a study on caregivers of Alzheimer's patients found that an 8-week mindfulness-based stress reduction course significantly improved their psychological resilience. Another study on caregivers of people with mental illness showed that mindfulness and self-compassion were important in reducing depression, anxiety, and stress over six months. These findings suggest that mindfulness programs can help caregivers manage their stress and improve their well-being. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Mindful and Self-Compassionate Care Program (MASC) for caregiver stress?

Research shows that mindfulness and self-compassion training can help reduce stress and improve resilience in caregivers, as seen in studies with caregivers of Alzheimer's patients and nurses. These programs have been associated with lower levels of depression, anxiety, and stress, suggesting that similar benefits might be expected from the MASC program. ^{1 2 3 4 5}

What safety data exists for the Mindfulness Program for Caregiver Stress?

The provided research does not contain specific safety data for the Mindfulness Program for Caregiver Stress or its variants like the Mindful and Self-Compassionate Care Program (MASC). The studies focus on self-directed care models for mental health, which are not directly related to the mindfulness program in question. ^{6 7 8 9 10}

Is the Mindfulness Program for Caregiver Stress safe for participants?

Research on mindfulness-based programs, including Mindful Self-Compassion, suggests they are generally safe, but the potential for harm has not been comprehensively studied. Participants in these programs often report high satisfaction and improved well-being, but more research is needed to fully understand any risks. ^{1 11 12 13 14}

Is the Mindful and Self-Compassionate Care Program (MASC) a promising treatment for caregiver stress?

Yes, the Mindful and Self-Compassionate Care Program (MASC) is a promising treatment for caregiver stress. Mindfulness-based programs, like MASC, have been shown to improve psychological resilience, reduce stress, anxiety, and depression, and enhance overall well-being for caregivers. These programs can be delivered in a cost-effective manner, such as through mobile apps, making them accessible and beneficial for caregivers of dementia patients. ^{1 15 16 17 18}

How is the Mindful and Self-Compassionate Care Program (MASC) treatment different from other treatments for caregiver stress?

The Mindful and Self-Compassionate Care Program (MASC) is unique because it combines mindfulness practices with self-compassion techniques, which may enhance psychological resilience and reduce stress in caregivers. Unlike other treatments, it focuses on both mindfulness and self-compassion, potentially offering a more holistic approach to managing caregiver stress. ^{1 15 16 17 18}

What is the purpose of this trial?

Building on limitations of prior research, the investigators developed 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. The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial. Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.

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 caregivers of individuals with Alzheimer's Disease and Related Dementias (ADRD) who experience stress from their caregiving duties. It aims to help them manage this stress, including the challenges that come with difficult patient behaviors.

Inclusion Criteria

English fluency and literacy

Must live with and care for an individual with ADRD

Must have been in a caregiver role for more than 6 months

Exclusion Criteria

Recent change in psychotropic treatment for depression or anxiety

Involvement in another clinical trial for caregivers

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

6-8 weeks

6 virtual group sessions

Follow-up

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

3 months

Treatment Details

Interventions

• Mindful and Self-Compassionate Care Program (MASC)

Trial Overview The trial tests a new program called MASC which teaches mindfulness, self-compassion, and behavioral management skills through group training. Its effectiveness will be compared to a Health Education Program in a pilot randomized controlled trial.

Participant Groups

Group I: Mindful and Self-Compassionate Care Program (MASC) Experimental Treatment 1 Intervention

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

Group II: Health Education Program (HEP) Active Control 1 Intervention

The control arm will be comprised of: Six Virtual Group Sessions. The sessions will discuss caregiver stress, sleep hygiene, nutrition, and ways to stay physically active as a caregiver. At Home Practice. After each group session, participants will have the opportunity to complete journal exercises that encourage them to integrate the health information that they learn into their daily lives.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

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]

Nurses who practice mindful self-compassion (MSC) training are likely to experience greater resilience against stress and burnout, which can enhance their ability to provide compassionate care to patients.

The article reviews the effectiveness of an MSC curriculum and offers practical techniques for nurses to implement MSC strategies in their daily routines, promoting both their well-being and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of mindful self-compassion for frontline nurses. Biber, DD.[2023]

An 8-week compassion cultivation training (CCT) program significantly reduced psychological distress in caregivers of individuals with mental illness, with 161 participants assessed over 6 months.

Key mediators of this reduction included self-compassion and mindfulness, which were shown to effectively lower levels of depression, anxiety, and stress among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators for the Effect of Compassion Cultivating Training: A Longitudinal Path Analysis in a Randomized Controlled Trial Among Caregivers of People With Mental Illness. Hansen, NH., Fjorback, LO., Frydenberg, M., et al.[2021]

A brief mindfulness-based curriculum delivered in five one-hour sessions was feasible and well-received by 29 palliative care providers, leading to significant improvements in mindfulness and mindfulness practices that were maintained for seven months.

While participants reported lower burnout levels than national averages, there was no significant change in burnout over the study period, suggesting that while mindfulness training is beneficial, it may not directly reduce burnout in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Mindfulness-Based Self-Care Curriculum for an Interprofessional Group of Palliative Care Providers. Podgurski, L., Greco, C., Croom, A., et al.[2020]

Written emotional disclosure showed a significant short-term reduction in caregiver burden, as measured by the Zarit Caregiver Burden Index, with a decline of -4.21 points at week 4 compared to control, although this effect diminished by week 8.

While overall distress and quality of life worsened for all groups, the written emotional disclosure group experienced the least worsening, suggesting it may be a beneficial strategy for managing caregiver distress in the context of advanced liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Tapper, EB., Saleh, ZM., Lizza, S., et al.[2023]

The Florida Self-Directed Care (FloridaSDC) program, which serves individuals with severe mental illness, allows participants to manage their own care budgets, leading to modest improvements in their functional assessment scores while they remained in the community.

Despite low income and limited employment among participants, their ability to make personalized service choices did not negatively impact their outcomes, suggesting that self-directed care can be effective in supporting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-directed care: participants' service utilization and outcomes. Spaulding-Givens, JC., Lacasse, JR.[2018]

Self-directed care (SDC) significantly improved outcomes for low-income individuals with serious mental illness, including greater perceived competence in self-management, better recovery from symptoms, and increased employment compared to traditional services.

Despite the enhanced outcomes, SDC did not lead to higher service costs, indicating that it can be a cost-effective alternative to standard mental health care while maintaining high user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Self-Directed Care for Medically Uninsured Adults With Serious Mental Illness. Cook, JA., Jonikas, JA., Burke-Miller, JK., et al.[2023]

Participants in a self-directed care program showed significant improvements in their recovery, spending less time in psychiatric inpatient and criminal justice settings after enrollment compared to the year before.

The program allowed participants to control approximately $58,000 in funds, with nearly half spent on traditional psychiatric services, indicating a preference for conventional care while also exploring alternative supports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic grand rounds: a self-directed care model for mental health recovery. Cook, JA., Russell, C., Grey, DD., et al.[2017]

Programs of All-Inclusive Care for the Elderly (PACE) are effectively positioned to provide integrated, person-centered care for older adults with co-occurring serious mental illness and substance misuse, addressing their complex medical and emotional needs.

A case study highlighted the importance of understanding the impact of trauma on the mental health and substance use of dual-diagnosis patients, emphasizing the need for tailored care strategies within the PACE model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Person-Centered Care for Older Adults With Serious Mental Illness and Substance Misuse Within a Program of All-Inclusive Care for the Elderly. Cacchione, PZ., Eible, L., Gill, LL., et al.[2018]

In a study involving 60 participants with serious mental illness, self-directed care (SDC) allowed individuals to make 507 requests for nontraditional goods and services, highlighting their need for personalized support beyond conventional mental health services.

The most common requests focused on self-care and general tasks, indicating that SDC can empower individuals to address unmet needs and utilize personal-medicine strategies effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Personal Medicine as Part of Self-Directed Care: Expanding Perspectives on Medical Necessity. Snethen, G., Bilger, A., Maula, EC., et al.[2018]

While mindfulness-based programs (MBPs) are known for their benefits, the potential for harm has not been thoroughly investigated, indicating a need for more research in this area.

The study identifies three key factors that may contribute to harm in MBPs: program-related factors, participant-related factors, and clinician-related factors, suggesting that understanding these can help improve safety and effectiveness in future mindfulness practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. Baer, R., Crane, C., Miller, E., et al.[2023]

Mindfulness and compassion practices, such as focus and insight meditation, are effective in reducing stress among healthcare professionals, helping them manage emotional distress and improve emotional regulation.

Training in mindfulness and compassion can transform empathy into compassion, which may counteract empathy fatigue and enhance self-care, making group training in healthcare settings a beneficial approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevent burnout in health care with mindfulness and compassion]. Yu, W.[2019]

A randomized controlled trial is underway to assess the feasibility and effectiveness of the Healthy Minds Program (HMP) mobile app in reducing stress and emotional distress among caregivers of individuals with Alzheimer's disease and related dementias, with 80 caregivers expected to participate over 12 weeks.

Preliminary enrollment has begun, with 27 caregivers enrolled as of June 2023, indicating the potential for HMP to be a cost-effective intervention that improves caregiver health and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial. Woodworth, EC., Briskin, EA., Plys, E., et al.[2023]

A study involving 16 participants with chronic diseases and their caregivers revealed that mindfulness programs could effectively reduce stress related to disease management, highlighting the importance of addressing the unique stressors faced by this population.

Participants expressed a need for mindfulness programs to be tailored to their specific circumstances, suggesting that culturally relevant instruction and accessible formats could enhance participation and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of mindfulness practices as a support for individuals managing caregiving responsibilities and chronic disease: A qualitative study. West, NT., Harmon, BE., Rawlett, KE., et al.[2023]

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]

A feasibility study involving 19 certified nursing assistants (CNAs) in long-term care settings showed that an online mindfulness-based intervention (MBI) significantly reduced depressive symptoms, with a moderate effect size (d = 0.47).

Out of the initial participants, 68% completed the intervention, suggesting that MBIs could be a promising approach to improve job satisfaction and reduce burnout among CNAs, warranting further research with a larger group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Online Mindfulness-based Intervention for Certified Nursing Assistants in Long-term Care. Young, CC., Kesler, S., Walker, VG., et al.[2023]

References

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

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. [2021]

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

Benefits of mindful self-compassion for frontline nurses. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Mediators for the Effect of Compassion Cultivating Training: A Longitudinal Path Analysis in a Randomized Controlled Trial Among Caregivers of People With Mental Illness. [2021]

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

A Brief Mindfulness-Based Self-Care Curriculum for an Interprofessional Group of Palliative Care Providers. [2020]

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

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. [2023]

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

Self-directed care: participants' service utilization and outcomes. [2018]

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

Randomized Controlled Trial of Self-Directed Care for Medically Uninsured Adults With Serious Mental Illness. [2023]

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

Economic grand rounds: a self-directed care model for mental health recovery. [2017]

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

Person-Centered Care for Older Adults With Serious Mental Illness and Substance Misuse Within a Program of All-Inclusive Care for the Elderly. [2018]

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

Exploring Personal Medicine as Part of Self-Directed Care: Expanding Perspectives on Medical Necessity. [2018]

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

Mindfulness Self-Compassion: Helping Family Caregivers Cope with Cognitive Behaviors of Dementia. [2023]

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

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. [2023]

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Psychophysiological stress response after a 6-week Mindful Self-Compassion training in psychiatric rehabilitation inpatients: a randomized post-test only study. [2023]

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[Prevent burnout in health care with mindfulness and compassion]. [2019]

15. Canada pubmed.ncbi.nlm.nih.gov

Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial. [2023]

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

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[Effectiveness of a mindfulness-based stress reduction program for family caregivers of people with dementia. Systematic review of randomised clinical trials]. [2020]

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An Online Mindfulness-based Intervention for Certified Nursing Assistants in Long-term Care. [2023]